Biotech & Pharma Jobs

Sr. Quality Review Specialist – Regulatory Documentation and Submissions

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Sr. Quality Review Specialist – Regulatory Documentation and Submissions at a prestigious Fortune 500® company working in Foster City. Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within. Job Title: Sr. Quality Review Specialist – Regulatory Documentation and Submissions Pay: $60 – 73 per hour depending on experience Duties The Quality department resides organizationally within Regulatory Documentation and Submissions (RDS) and provides various services including, but not limited to: quality reviews (data/content verification and consistency, style application, editing), audit readiness support, process improvement support, and compliance monitoring to support a wide variety of regulatory submissions across all therapeutic indications. Responsibilities of the Senior Associate, RDS Quality, include the following : •Perform high-quality reviews of regulatory deliverables •Function as the RDS Quality Lead for various regulatory deliverables •Assist in audit preparation •Support RDS Quality initiatives •Act as a departmental RDS Quality resource •Performs detailed and thorough quality reviews to ensure data integrity, internal content consistency, completeness on a wide range of regulatory deliverables (CSRs, IB/Updates, CTDs, PK/Pop PK reports, etc.) in accordance with RDS Quality standards and tools. •Performs editorial reviews to ensure style is consistent with the R & D Manual of Style and within regulatory deliverable. •Serves at the primary RDS Quality point-of-contact for assigned deliverables, monitors timelines, communicates with Lead Writer to ensure review expectations are understood and met, and alerts Lead Writer in a timely manner if deliverable is at risk. •Participates in RDS Quality team meetings presenting timelines and updates of assigned deliverables alerting team of any potential resourcing issues. Advises on deliverable review strategies. •Able to forecast individual project workload and proactively identify and communicate potential workload peaks. •Closely collaborates with Audit SME and Lead Writer to support audit preparation by gathering documents and performing quality review to ensure audit package is complete and accurate. •Assists with the development and delivery of relevant training and new hire o on boarding programs. •Participates in development and/or revision of internal policies and procedures impacting quality standards and tools. •Contributes to the development and maintenance of applicable standard operating procedures, manuals, and work practices. •Responds to general Quality questions, helps train writers on review process and expectations, and remains current with industry Quality standards. •Ability to work independently on basic job duties and understands criticality and time expectations of assigned activities and prioritizes as appropriate. •Has developed organizational skills; is detail oriented; and able to work in a fast paced, deadline-driven environment. •Displays flexible thinking and willingness to adapt to changing approaches based on project needs and expectations. •Familiar with AMA Manual of Style. •Has excellent verbal and written communication skills and interpersonal skills. •Can effectively communicate with a variety of teams and individuals, including team leadership and members of senior management. •Is capable of using advanced functions of various software applications, particularly the Microsoft Office Suite, Adobe Acrobat, and a Regulatory Document Management System. Requirements : •A BS degree •A minimum of 4+ years of relevant experience within clinical R&D or regulatory affairs such as pharmaceuticals/biotechnology, including a minimum of 2 or more years of relevant experience in a medical writing/clinical submissions environment preparing documents for regulatory submissions. •Ideal candidates include those who are familiar with Phase 1 to 3 clinical protocols and study reports and understand the drug development process leading to marketing applications •Well developed computer skills including proficiency in Word, Adobe and Excel. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com . Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world. Kelly Services is an Equal Opportunity Employer Why Kelly ® ? With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year. You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today. About Kelly ® At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ]]

Director of Software Operations (Reliability & Infrastructure)

Director of Software Operations (Reliability & Infrastructure) Based in Redwood City, CA, we are a publicly-traded biotechnology software company focused on reproductive and clinical testing products. We are a collective group of people committed to saving people’s lives! We are a team of Software & QA Engineers, Data Scientists, Bioinformaticians, and Product Managers who are passionate about building systems that will make a real-world impact. Currently, we are looking to bring on a Director of Software Infrastructure & Reliability who will be responsible for DevOps infrastructure, reliability, and technical support of our software in production. If you would like to have strategic and operational ownership of DevOps/SecOps and production support, and also mature our CI/CD processes, we would love the time to tell you more about this amazing opportunity! Top Reasons to Work with Us 1. Work with cutting edge technologies and one of the most advanced products in the diagnostics industry. 2. Join a world class Engineering/PM team with a solid work/life balance and great flexibility 3. Growth, Our trajectory has been on a steady upswing. We are a continually growing and stable publicly traded company (as of 2 years ago). 4. Rewarding – Help families identify and manage genetic diseases 5. Stock options/RSUs 6. Work with a passionate, bright, uplifting, and a go-the-extra-mile for your colleague group. What You Will Be Doing – This individual will be responsible for DevOps infrastructure, reliability and technical support of our software in production. Strategic and operational ownership of DevOps/DevSecOps and production support. – Responsible for setting up and managing CI/CD, DevOps and DevSecOps processes. – Lead continuous improvement projects with the objective to maximize the reliability and scalability of our applications. – Partner with the business teams to analyze, implement, and support a global, technical support model and group that meets the business objectives. – Work closely with developers, QA engineers, and engineering management to create and maintain reliable and scalable infrastructure for our software. – Lead 2 teams (15 members) – Develop the vision, goals, priorities and work alongside the team to accomplish them. – Drive operational excellence; highly scalable and reliable infrastructure, excellent customer service, efficient and agile operations measured with industry-leading metrics. – Implement and manage CI/CD, DevOps and DevSecOps across the department. – Ensure compliance of platform components including security and monitoring mechanisms. – Lead development of internal tools to facilitate engineering infrastructure and support activities. – Guide the career development of team members, including both technical and interpersonal skills necessary for being effective and successful in a professional software engineering organization. What You Need for this Position – BS or MS in Computer Science or equivalent industry experience – 5+ years of experience managing BOTH DevOps/SRE Teams and Technical Support Teams – 5+ years of experience as a Software Engineer, Infrastructure Engineer, SRE, or a DevOps engineer. – Experience managing remote teams – Experience writing code in either Java or Python. – Good knowledge of relational databases – Hands-on experience with managing infrastructure in AWS. – Experience with provisioning tools, like Ansible, Terraform. – Experience with Docker, Jenkins, Kubernetes and/or Rancher. – Hands-on experience implementing, troubleshooting, and supporting Internet-based applications, web servers, data storage, workflow engines, and Linux/Unix operating systems. -Nice to have/preferred skills and experience: – Experience with Atlassian stack (Bitbucket, Bamboo) – Experience in the healthcare or biotech domain – Proven ability to execute in a customer-focused environment and advocate for customers across a cross-functional organization. – MS in CS What’s In It for You 1. Salary 2. Bonus (20%) 3. Stock options/RSUs 4. Excellent ESPP 5. Competitive Benefits 6. Healthy Catered Lunches 7. Onsite Gym 8. Game room/TV 9. Onsite Dry Cleaning & Alteration Service 10. Company Organized Sports Leagues 11. 401k Matching 12. PTO 13. Commuter FSA Program So, if you have a strong DevOps and Infrastructure background, with a desire to grow and be challenged, please apply today! – Applicants must be authorized to work in the U.S. CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Director of Software Operations (Reliability & Infrastructure)

Director of Software Operations (Reliability & Infrastructure) Based in Redwood City, CA, we are a publicly-traded biotechnology software company focused on reproductive and clinical testing products. We are a collective group of people committed to saving people’s lives! We are a team of Software & QA Engineers, Data Scientists, Bioinformaticians, and Product Managers who are passionate about building systems that will make a real-world impact. Currently, we are looking to bring on a Director of Software Operations who will be responsible for DevOps infrastructure, reliability, and technical support of our software in production. If you would like to have strategic and operational ownership of DevOps/SecOps and production support, and also mature our CI/CD processes, we would love the time to tell you more about this amazing opportunity! Top Reasons to Work with Us 1. Work with cutting edge technologies and one of the most advanced products in the diagnostics industry. 2. Join a world class Engineering/PM team with a solid work/life balance and great flexibility 3. Growth, Our trajectory has been on a steady upswing. We are a continually growing and stable publicly traded company (as of 2 years ago). 4. Rewarding – Help families identify and manage genetic diseases 5. Stock options/RSUs 6. Work with a passionate, bright, uplifting, and a go-the-extra-mile for your colleague group. What You Will Be Doing – This individual will be responsible for DevOps infrastructure, reliability and technical support of our software in production. Strategic and operational ownership of DevOps/DevSecOps and production support. – Responsible for setting up and managing CI/CD, DevOps and DevSecOps processes. – Lead continuous improvement projects with the objective to maximize the reliability and scalability of our applications. – Partner with the business teams to analyze, implement, and support a global, technical support model and group that meets the business objectives. – Work closely with developers, QA engineers, and engineering management to create and maintain reliable and scalable infrastructure for our software. – Lead 2 teams (15 members) – Develop the vision, goals, priorities and work alongside the team to accomplish them. – Drive operational excellence; highly scalable and reliable infrastructure, excellent customer service, efficient and agile operations measured with industry-leading metrics. – Implement and manage CI/CD, DevOps and DevSecOps across the department. – Ensure compliance of platform components including security and monitoring mechanisms. – Lead development of internal tools to facilitate engineering infrastructure and support activities. – Guide the career development of team members, including both technical and interpersonal skills necessary for being effective and successful in a professional software engineering organization. What You Need for this Position – BS or MS in Computer Science or equivalent industry experience – 5+ years of experience managing BOTH DevOps/SRE Teams and Technical Support Teams – 5+ years of experience as a Software Engineer, Infrastructure Engineer, SRE, or a DevOps engineer. – Experience managing remote teams – Experience writing code in either Java or Python. – Good knowledge of relational databases – Hands-on experience with managing infrastructure in AWS. – Experience with provisioning tools, like Ansible, Terraform. – Experience with Docker, Jenkins, Kubernetes and/or Rancher. – Hands-on experience implementing, troubleshooting, and supporting Internet-based applications, web servers, data storage, workflow engines, and Linux/Unix operating systems. -Nice to have/preferred skills and experience: – Experience with Atlassian stack (Bitbucket, Bamboo) – Experience in the healthcare or biotech domain – Proven ability to execute in a customer-focused environment and advocate for customers across a cross-functional organization. – MS in CS What’s In It for You 1. Salary 2. Bonus (20%) 3. Stock options/RSUs 4. Excellent ESPP 5. Competitive Benefits 6. Healthy Catered Lunches 7. Onsite Gym 8. Game room/TV 9. Onsite Dry Cleaning & Alteration Service 10. Company Organized Sports Leagues 11. 401k Matching 12. PTO 13. Commuter FSA Program So, if you have a strong DevOps and Infrastructure background, with a desire to grow and be challenged, please apply today! – Applicants must be authorized to work in the U.S. CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Senior Site Reliability Engineer (Remote)

Senior Site Reliability Engineer (Remote) -This position can be fully remote but is a big plus if you are local to Philadelphia- Job Title: Senior Site Reliability Engineer Salary: $120k- $160k DOE, Benefits, 401k Match We are fast growing and extremely well funded SaaS healthcare and data analytics company. Our software is relied on heavily by pharmaceutical/ biotech companies, government agencies, and healthcare providers. We are backed by huge partners including significant investment by Google Ventures. We are looking for more to continue the success of our company. The best part is we never go stale with technology! We are always expanding and pushing the boundaries with modern technology. If you like rolling up your sleeves and growing with a tech company that values your opinions please apply today! Top Reasons to Work with Us – Competitive Salary ($120k – $160k) + 401k Matching + Great Benefits + PTO – Opportunity to work both independently and part of a larger team with various levels of responsibilities – Opportunity to join an early stage + Well funded startup with an existing customer base and a growing list of partners – Work Remote! What You Will Be Doing – Develop tooling, Infrastructure, APIs, etc. – Development and architecture for highly-available services and data – Automate the entire lifecycle of production microservices What You Need for this Position – 5-10+ years of software development with experience/knowledge with: – Site Reliability – AWS infrastructure – Kubernetes – Terraform – Kafka – Docker/Linux containers is a plus – Experience with Javascript/Node, Python, Go, Ruby, etc. – Experience at a healthcare software company is a plus – BS in CS (or related is preferred) So, if you are a Senior Site Reliability Engineer (Remote) with experience, please apply today! – Applicants must be authorized to work in the U.S. CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Director of Real World Evidence (RWE)

Director of Real World Evidence (RWE) If you are a Director of Real World Evidence (RWE) with experience, please read on! Top Reasons to Work with Us We are an international healthcare consultancy specializing in end to end evidence development, optimization, and communication. The company’s core competencies reside in Meta Research, Modeling, Data Analytics, Scientific Writing and Simulation & Risk Analytics. Senior Management has over 50 years of life sciences experience working in pharma, medical device, consulting, and academia. Through our integrated capabilities in data analytics, epidemiology, health economics, market access and medical communications, we provide our clients with a competitive edge in this dynamic market environment. What You Will Be Doing You will be taking on a senior level within our company and working to support new business, accountable to revenue targets/budgets, and cultivate key client relationships within the health-care/pharmaceutical industries. Location: Hoboken, NJ…Remote may be considered for strong candidates Responsibilities: – Business leadership: Serve as primary client contact and project leader to ensure all deliverable are met. Participate in new business development and identification of client expansion opportunities. – Project Oversight: Oversee a team of RWE researchers and projects for pharma/medical device/bio-tech clients. Develop process and methodology of projects with upper management. – Management: Supervise execution of projects in a matrix environment and assist in preparation of high-quality client deliverables in a timely manner. Provide oversight to team members and present deliverables to client. – Business Development: Participate in new business development and cultivation of key client relationships. What You Need for this Position MUST HAVE: – Masters/PharmD/PhD in relevant discipline – 5+ years of health-care/pharma/life-science industry experience or consulting experience – Global and US Real World Evidence (RWE) research experience – Demonstrable project leadership and business leadership experience – Experience working in a matrix environment and adaptability to client projects. NICE TO HAVE: – Specialty and Rare Disease experience What’s In It for You – Competitive Salary DOE – 401(k) with match – Generous PTO – Comprehensive Benefits package – Remote option available So, if you are a Director of Real World Evidence (RWE) with experience, please apply today! – Applicants must be authorized to work in the U.S. CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

FP&A Project Manager

Hello, My name is George Rogers and I am a Recruiter with Kelly Services, Inc., a Fortune 500 workforce solutions company. We are currently seeking to fill an FP&A Project Manager position in Foster City, CA. I have attached the details of the opportunity below: Duration: 12+ months Pay: $70.00 – $78.00/HOUR Description: Seeking a Finance Manager to join the Pharmaceutical Development & Manufacturing (PDM) Finance organization, based in Foster City, CA. The individual will provide project management and operational support to the PDM Finance team; specifically, he/she will be responsible for actively supporting the coordination and execution of project related ERP upgrade activities and providing financial management and business support for the month end close and reporting process, forecast development, and other related reporting and analytical tasks as required. A summary of key characteristics includes: Project Management: The candidate must possess the ability to actively coordinate the execution of projects that involve cross-functional stakeholders. This includes providing communication and guidance on project scope and timelines, coordinating testing processes, and providing feedback on project deliverables. Results Orientation: The ideal candidate will be results-driven and must thrive in a fast-paced, dynamic environment. He/She must have the ability to lead and meet deadlines for multiple priorities and projects and take ownership of issues and resolve them in a timely manner. A “can-do” attitude is an absolute must. Willingness to be hands-on: The candidate must be an independent self-starter with a willingness to become involved in operations to understand the processes and provide value added financial support. Collaboration: The candidate must demonstrate an ability to build strong relationships with Finance and other partners. The candidate should be a proactive leader exhibiting strong influencing capabilities and a willingness to maintain open and transparent communication within the company’s matrixed organization. Business Savvy and Financial Acumen: The candidate will possess exceptional financial analytical and problem-solving skills. These skills must be balanced by sound business judgment. Essential Duties and Job Functions: Establishes strong partnerships with the PDM Finance organization to provide comprehensive financial management and business support for forecasting, monthly close activities, management reporting processes and other related reporting and analytical tasks. Supports PDM financial reporting including planning and delivery of management reporting packages for budgeting, monthly close and other corporate requirements. Delivers accurate and timely reporting to drive discussions on business trends, forecast accuracy and upcoming projects/activities. Drives development of meaningful financial analyses and creates effective presentations to communicate conclusions and recommendations. Provides ongoing maintenance and clean-up support of financial master data and managerial hierarchy reporting structures. Supports development, updates, and periodic reviews of financial SOPs. Coordinates efforts of ERP upgrade testing process, including providing communication and feedback to project team. Manages and/or supports key PDM projects. Proactively engages with Finance colleagues and other partners to drive forward the execution of projects, ensuring quality and timeliness of deliverables. Supports ad hoc requests and ongoing analytics support to assist the PDM finance organization with tactical and strategic decision-making processes. Knowledge, Experience and Skillsets: 6+ years of relevant experience in Finance, having held positions of increasing scope and responsibility. A BS or BA is required and a CPA is preferred. MBA is a plus. Must have proficiency with Oracle, Hyperion, Microsoft Excel and PowerPoint. Demonstrated project management experience Excellent communication, interpersonal skills as well as the ability to work independently and as part of a team. Excellent problem solving and analytical abilities. Experience with project reporting, operational accounting and reporting is required. Demonstrated success working in a deadline driven and multi-task environment. Prior experience in biotech or pharmaceuticals industry or supporting manufacturing is preferred. Experience in multi-national organization a plus. **Important information : This position is recruited for by a remote Kelly office, not your local Kelly branch. Please submit your resume to be considered for this position by pressing the “SUBMIT RESUME” button below. If you have questions about the position, you may contact the recruiter recruiting for this position ( George.Rogers@kellyservices.com ), however, your resume should be uploaded via the “SUBMIT RESUME” button included within** Why Kelly ® ? As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined. About Kelly ® At Kelly , we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. #KellyGTS ]]

Senior Web (React) Engineer

Senior Web (React) Engineer Job Title: Senior Web Software Engineer Job Location: New York, NY (Midtown) Salary: $130k- $175k DOE, Benefits, 401k Match Requirements: 8+ years with Javascript, HTML/CSS, etc. + React experience We are fast growing and extremely well funded SaaS healthcare and data analytics company. Our software is relied on heavily by pharmaceutical/ biotech companies, government agencies, and healthcare providers. We are backed by huge partners including significant investment by Google Ventures. We are looking for more to continue the success of our company. The best part is we never go stale with technology! We are always expanding and pushing the boundaries with modern technology. If you like rolling up your sleeves and growing with a tech company that values your opinions please apply today! Top Reasons to Work with Us – Competitive Salary ($130k – $175k) + 401k Matching + Great Benefits + PTO – Partial Remote work – 401k Match – Dynamic and exciting work environment – Full Benefits (health, dental, vision, etc.) – Established and growing! What You Will Be Doing – Contribute to the technology and architecture of a global production-scale service layer – Code as part of a high-performing team in an Agile environment – Tackle architectural challenges around high availability of services and data – Continue to learn and expand your knowledge and skill set – Build features that serve customer-driven product goals – Prototype new ideas and explore new solutions additive to the growing list of problems the platform solves – Be comfortable translating requirements and wireframes into layouts for variety of browsers What You Need for this Position – 8+ years software development – JavaScript – React – HTML/CSS – Experience building scalable systems with cloud infrastructures like AWS or GCP is preferred – Healthcare/HIPAA experience is a big plus – BS in CS (or related) is desired So, if you are a Senior Web (React) Engineer with experience, please apply today! – Applicants must be authorized to work in the U.S. CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Associate Director-R&D

Job DetailsExperience 10 – 15 YearsAnnual Salary 130000.00-150000.00 USDWork Location Central Islip, New York, USADomain Pharmaceuticals/Biotechnology/Clinical ResearchJob DescriptionThe Associate Director, R&D (Solid Oral Dosage Form Product Transfer) position will lead all research and development (R&D) activities at co. NY . In this hands-on role the Associate Director, Technology Transfer, Solid Oral Dosage Forms (OSD), will be responsible for and provide technical leadership as related to technology transfer of product from company network of manufacturing facilities to another internal facility or to an external partner (e.g., CDMO/CRO). This position will report into the Senior Vice President and Head of R&D, North America. This position is based out of Long Island, NY. The job duties for this position include but are not limited to the following: Hands-on leadership of all R&D activities as related to product transfer of solid oral dosage form (OSD) products via the 505(j) pathway.Provide technical leadership as related to pre-formulation, formulation, manufacturing process development, technology transfer, established product support, analytical sciences with a focus on active pharmaceutical ingredient (API), excipients, intermediates and finished products. Single point accountability to lead a team of 1-3 scientists to implement technology transfer projects in a time bound manner to achieve business objectives.Manage scope, cost, time of projects as related to delivery against business objectives.Assess product characteristics and specific technologies associated with the products that are required to be transferred to ensure success at the receiving site.Assess equipment train associated with the approved products that are required to be transferred and use creative approaches to ensure product is successfully transferred with equipment train differences between transferring and receiving sites.Assess analytical methods associated with the approved products and proactively plan and implement analytical method transfer, verification or validation, as required. Assess strategy, plan and lead stability studies required to submit regulatory documents as related to qualification of second site.Work with Cipla global Regulatory Affairs to identify and draft strategy for product transfer; conduct relevant studies; provide and compile data for submission of regulatory approvals as related to qualification of second site.Work with Cipla global Supply Chain to proactively identify and troubleshoot supply chain topics to meet product transfer business objectives.Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to line functions. Maintain effective and pro-active communication and coordination of activities and deliverables with multi-functional stakeholders across geographical locations.Maintain effective working relationship and act as single-point technical contact for contract research organizations (CROs) and/or contract development and manufacturing organizations (CDMOs). Collaborate with project management (PM) function to lead execution of activities against approved plan.Train staff, peers and junior staff members on new techniques. TYPICAL DAY-TO-DAY ACTIVITIES Product transferTechnology transferTransferability assessmentEquipment train assessmentAnalytical method assessmentConsultation with supply chainR&D activities such as pre-formulation, formulation, process development or analytical method developmentTechnical troubleshootingProcess validationsMethod verificationsMethod validationsLeading activities at CROs and CMOsStability study managementDrafting dossier supportive documentsDrafting and responding to relevant requests from the US FDA or EU authoritiesTechnical ManagementFunctional Group Management EDUCATION AND EXPERIENCE Doctorate in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.Successful candidate may have specific background in Formulation and Process Development of solid oral dosage forms (OSD e.g., Tablets, Capsules etc.).Minimum 10 years of industry experience with demonstrated expertise in relevant area is required.In-depth understanding of physical pharmacy, physical chemistry, thermodynamics, chemical reaction kinetics is a must.In-depth understanding of various pre-formulation and formulation studies including excipient compatibility, forced degradation studies and unit steps in formulation manufacture is a must.In-depth understanding of pilot-scale and manufacturing-scale equipment is a must.Experience with process analytical technologies (PAT) is a plus.Experience with Analytical Sciences is a plus. PROFESSIONAL COMPETENCIES AND TECHNICAL SKILLSMust possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.Strong command over written and verbal English is a must. Past publication experience is a must.Must be able to work under minimal supervision and able to work independently and in a team environment.Must be able to exercise appropriate professional judgment on matters of significance.Must be proficient in computer skills and software applications such as Microsoft Office tools.Knowledge of statistical packages is a plus.Must communicate clearly and concisely across levels, both orally and in written. OTHER JOB INFORMATION Relocation negotiable.Employment sponsorship negotiable.No remote work available.Must be willing to work some weekends based on a relevant business need, if required.

Director R&D Analytical USA

Global Company InfoClient is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened their leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Company employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Company focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.A Pharmaceutical, also known as a company in New York, is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. Job DetailsExperience 10 – 15 YearsAnnual Salary Mid 100k-High 100k USDWork Location USADomainPharmaceuticals/Biotechnology/Clinical ResearchJob DescriptionThe Therapeutics business offers an opportunity to transform a generics company into an innovation-driven specialty business. This role is a unique opportunity to build a business with the backing of an 80-year-old legacy of sophisticated dosage forms expertise, CMC expertise, large scale manufacturing, and drug delivery. Company has a proven performance track record in 100 countries with over 1000+ products across various therapeutic categories. Company is known for creating businesses that are sustainable with a high focus on continuous innovation in R&D (with 20+ world firsts so far). Therapeutics will focus on Anti-infectives, Pain, Neurology and Respiratory therapies and building out a Branded business. Its Neurology pipeline has two early-stage assets in Spasticity, while in Respiratory, it has a Phase 2 ongoing asset for Aspergillosis in Asthma patients. It also has a Phase 3 completed “opioid-sparing” program for mild to moderate pain in hospital patients. It recently acquired an approved new generation intravenous aminoglycoside for cUTI.JOB DESCRIPTION The Director, R&D, Synthetic Organic Small Molecule Analytical Sciences position will lead all analytical sciences research and development (R&D) activities at Therapeutics. In this role the Director may lead a small team comprised of internal resources and/or contractors. The focus is on all topics analytical chemistry as applied to synthetic organic small molecule active pharmaceutical ingredient (API), formulation, process development and technology transfer. This position will report into the Senior Vice President and Head of R&D, North America. This position is based out of Warren, NJ or Long Island, NY. The job duties for this position include but are not limited to the following: · – Lead all Analytical Sciences, R&D activities as related to development and registration of synthetic organic small molecule products via 505(b)(1) and 505(b)(2) new drug application (NDA) pathways.· – Manage a team of scientists (internal and/or contractors) on all topics Analytical Sciences as applied to API, per-formulation, formulation, manufacturing process development, technology transfer, and established product support.· – – Lead technical deliverables as related to API, excipients, intermediates and finished products.· – Spearhead and/or contribute towards internal pipeline projects and collaborations with development partners (strategic development partners, CROs, CDMOs etc.).· – Operate as the subject matter expert (SME) on analytical sciences including process analytical technologies (PAT). Products may range from internal product development projects, products that are commercialized, products that are in-licensed from external entity or products that are co-developed with a development partner. – Lead and/or contribute towards API, excipient, packaging characterization; excipient compatibility and forced degradation studies. Recommend stage appropriate acceptance criteria for vendor and regulatory specifications. Utilize relevant theoretical modeling and statistical tools, as required.· – Generate, review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction. Develop and implement strategies to control related substances, where applicable.· -Work with relevant cross-functional stakeholders (e.g., Commercial Operations, Quality Control, Quality Assurance, Supply Chain Management, Procurement etc.) on analytical method transfers from R&D to commercial functions.· -Contribute towards process development, process verification/qualification, process pre-validation, process validation, site and equipment qualification in collaboration with relevant stakeholders. · -Operate as the subject matter expert (SME) on analytical methods for various internal and external projects. Independently develop, assess and/or verify and validate analytical test methods for APIs, excipients, packaging components, devices and drug products using industry standard methodologies including QbD principles for analytical methods; US FDA or EU guidance’s and requirements; United States Pharmacopoeia (USP) guidelines; International Council for Harmonization (ICH) guidelines. Techniques may include standard tools like HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle size analyses, XRPD, DVS, Rheometer etc. to more specialized techniques such as LC-MS/MS, NMR, SS-NMR etc.· — Act as SME on extractable and leachable strategies and methodology.· – Responsible to be single-point technical contact for contract research organizations (CROs) and/or contract development and manufacturing organizations (CDMOs). Collaborate with project management (PM) function to lead execution of activities against approved plan.· – Provide relevant subject matter expertise in collaboration with external partners in the form of participation in technical strategy discussions; consultation on technical studies; hands-on characterization and/or third-party interface (e.g., CROs, CDMOs etc.) · – Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).· -Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to line functions. · -Independently draft and/or review standard operating procedures (SOPs).· – Maintain effective and pro-active communication and coordination of activities with multi-functional stakeholders.· -Draft and/or participate in drafting relevant sections of NDA dossiers towards 505(b)(1) and 505(b)(2) submissions. Lead studies in support of responses to United States Federal Drug Administration (FDA) information requests or deficiency letters for various dossiers.· -Train staff, peers and junior staff members on new techniques. TYPICAL DAY-TO-DAY ACTIVES · New product development· R&D activities such analytical method development and validation· New Analytical Method Development· Method Validations· Technical Troubleshooting· Technology Transfer· Leading activities at CROs and CMOs· Drafting new drug application (NDA) dossier supportive documents· Drafting and responding to r

Associate Director of Research & Development

REJECTAssociate Director of Research & Development Pharmaceuticals/Biotechnology/Clinical ResearchCentral Islip, New York, USAClient DetailsLEADING ARMACEUTICAL COMPANY In the last 80+ years, CO. has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. CO. is a fast-growing pharmaceutical company which the view to preserve our strong legacy and carve out a stronger future, we articulated our 2022 winning aspiration to double the number of patients we serve and hence double the impact we create as a global pharmaceutical company. Job DetailsExperience 10 – 15 YearsAnnual Salary 130000.00-150000.00 USDWork Location Central Islip, New York, USADomain Pharmaceuticals/Biotechnology/Clinical ResearchNO H1B employment sponsorship. Due to the amount of time required with H-1B transfer petitions and other related activities, it is our preference to not provide employment sponsorship. Please request the recruiters to provide resumes of candidates who do not require employment sponsorship. Thanks. Please find below the difference between the two Associate Director R&D Scientist roles. One position is to oversee the R&D team and activities for the Cipla New York (InvaGen Pharmaceuticals, Inc.) business unit. The other position is to oversee the R&D team and activities for the Cipla USA Exelan business unit which will also be located at the Cipla New York site.Other informations Both positions will report to the SVP of R&D.PhD is mandatory. JOB DESCRIPTION The Associate Director, R&D position will lead all research and development (R&D) activities at co. NY Pharmaceuticals Inc. In this role the Associate Director will lead a team of scientists comprised of formulation, process development, technology transfer and analytical sciences. This position will report into the Senior Vice President and Head of R&D, North America. This position is based out of Long Island, NY. The job duties for this position include but are not limited to the following: · Lead all R&D activities as related to development and registration of products via 505(b)(1), 505(b)(2) and 505(j) pathways.· Lead a team of scientists comprised of pre-formulation, formulation, manufacturing process development, technology transfer, established product support, analytical sciences with a focus on active pharmaceutical ingredient (API), excipients, intermediates and finished products.· Lead internal pipeline projects and collaborations with development partners (strategic development partners, CROs, CDMOs etc.).· Manage scope, cost, time of projects as related to delivery against business objectives.· Operate as the subject matter expert (SME) on pre-formulation and formulation, process development and technology transfer or analytical sciences as applied to development, characterization, process analytical technologies (PAT) and incorporation of active pharmaceutical ingredients (APIs), excipients, packaging material and devices to develop finished products. Products may range from internal product development projects, products that are commercialized, products that are in-licensed from external entity or products that are co-developed with a development partner. · Conduct API, excipient, packaging characterization; excipient compatibility and forced degradation studies. Recommend stage appropriate acceptance criteria for vendor and regulatory specifications. Utilize relevant theoretical modeling and statistical tools, as required.· Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE). Recommend stage appropriate acceptance criteria. Utilize PAT where feasible. Utilize relevant statistical tools, as required.· Review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction. Develop and implement strategies to control related substances, where applicable.· Work with relevant cross-functional stakeholders (e.g., Commercial Operations, Quality Control, Quality Assurance etc.) on scale-up and technology transfer of processes from R&D to commercial functions.· Lead and/or participate in activities related to process development, process verification/qualification, process pre-validation, process validation, site and equipment qualification in collaboration with relevant stakeholders. · Operate as the subject matter expert (SME) on analytical methods for various internal and external projects. Independently develop, assess and/or verify and validate analytical test methods for APIs, excipients, packaging components, devices and drug products using industry standard methodologies including QbD principles for analytical methods; US FDA or EU guidance’s and requirements; United States Pharmacopoeia (USP) guidelines; International Council for Harmonization (ICH) guidelines. Techniques may include standard tools like HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle size analyses, XRPD, DVS, Rheometer etc. to more specialized techniques such as LS-MS/MS, NMR, SS-NMR, Synchrotron etc.· Act as single-point technical contact for contract research organizations (CROs) and/or contract development and manufacturing organizations (CDMOs). Collaborate with project management (PM) function to lead execution of activities against approved plan.· Provide relevant subject matter expertise in collaboration with external partners in the form of participation in technical strategy discussions; consultation on technical studies; hands-on characterization and/or third-party interface (e.g., CROs, CDMOs etc.) · Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).· Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to line functions. · Independently draft and/or review standard operating procedures (SOPs).· Maintain effective and pro-active communication and coordination of activities with multi-functional stakeholders.· Draft and/or participate in drafting relevant sections of dossiers towards 505(b)(1), 505(b)(2) or 505(j) submissions. Lead studies in support of responses to United States Federal Drug Administration (FDA) information requests or deficiency letters for various dossiers.· Train staff, peers and junior staff members on new techniques. TYPICAL DAY-TO-DAY ACTIVIES · New product development· R&D activities such as pre-formulation, formulation, process development or analytical method development· Technical Troubleshooting· Technology Transfer· Process Validations· Method Validations· New Analytical Method Development· Leading activities at CROs and CMOs· Drafting dossier supportive documents· Drafting and responding to relevant requests from the US FDA or EU authorities· Working with external partners on technical activities· Technical Management· Functional Group Management EDUCATION AND EXPERIENCE · Doctorate in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry. Decorate in Biochemistry, Peptide Chemistry or Protein Chemistry is preferred.· Successful candidate must have a strong analytical and formulation background.· In-depth understanding of UV-Vis, Liquid Chromatography (LC), Gas Chromatography (GC) and

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