Biotech & Pharma Jobs

Medical Affairs Project Manager

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 Medical Affairs Project Manager at a prestigious Fortune 500® company working in Santa Monica. 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: Medical Affairs Project Manager Pay: $100 Duties : We are seeking a highly motivated individual to join us as a Program Manager, Medical Communications. This role is responsible for creating and managing core scientific content and for leading medical affairs advisory board meetings and congress activities. The Program Manager, Medical Communications will work with in-house medical directors to execute advisory board meetings and investigator meetings; work with the field Medical Science Liaisons to develop MSL tools, along with other key deliverables. This position will report to the Senior Director of Medical Communications. Responsibilities (include but are not limited to): • Develop Clinical/Scientific Advisory Board meeting materials; experience with contracts and FMV assessments • Develop core scientific content in support of key CAR T and TCR programs • Develop MSL tools in line with Medical Affairs strategy consisting of slide decks, interactive media, and training materials • Serve as point of contact for Medical Communications with field MSL team • Provide scientific content support to cross-functional and EU teams as needed • Coordinate with cross-functional team to deliver a strategic congress plan that may include: o Development of Medical Affairs exhibit materials o Coordination of scientific data assessment coverage o Executing large scientific exchange events o Conduct congress kickoff, alignment, and debrief sessions with key stakeholders o Planning and executing investigator events o Create and manage timelines to execute on congress deliverables o Align activities with corporate communications, marketing, investor relations, and MSLs • Source and manage external vendors to support deliverable development • Assist with developing company guidelines and SOPs pertaining to function • Collaborate across stakeholders to drive external communication strategies and deliverables Requirements : • Advanced degree in life science (PhD, Pharm D, MD) • 6+ years of experience in industry (eg, biotech/pharmaceutical/medical device company, Contract Research Organization, Medical Communications Agency), or academic research, including 3+ years in oncology • Extensive experience developing scientific slide decks and presentations • Excellent organizational, time management, budget management, and problem-solving skills • Ability to work across multi-disciplinary groups and to lead decision-making discussions • Excellent interpersonal, negotiation, communication, and collaborative skills with individuals, groups, and senior management (internal and external) • Experience in hematology/oncology and/or immuno-oncology or related therapeutic area preferred • Working knowledge of medical affairs, clinical, legal, regulatory functions; pre- and post-launch experience is strongly preferred 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.

Clinical Project Manager – Data Management

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 Clinical Project Manager at a prestigious Fortune 500® company working in Redwood City, CA. 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: Clinical Project Manager – Data Management Pay: $97 per hour Description This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences. Responsibilities •Aligns DSS study teams with program- and study-level strategies. Assigned programs may include programs that are of low complexity and size. For assigned programs and studies, leads the DSS Study Team and represents DS as a member of the cross-functional study team •For assigned programs and studies, acts as single point of contact and accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational objectives. Engages and connects global functional and cross-functional teams at the study level •Interacts with and influences cross-functional team members to achieve program objectives •Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions •Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development. If assigned, participates as the DS study owner in regulatory inspections and internal quality audits •Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance •Responsible for coaching and mentoring team members •Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives •Conducts study execution “lessons learned” across functions •May include indirect supervision of employee as well as supervision of work of contract resources Qualifications •Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred. PMP Certification or Lean Six Sigma Green Belt desired. •Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience). •In-depth understanding of clinical trial processes and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferred •Demonstrated performance as a functional leader •Demonstrated ability to influence others without direct authority •Demonstrated ability to successfully coach / mentor in a matrix environment •Demonstrated effective communication skills •Demonstrated effective analytical skills Monday to Friday WFH-One day a week Desired experience EDC Data Management Clinical Project Management 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.

Bilingual Recruiter (Spanish/English)

Kelly Services is currently seeking a Bilingual Recruiter (Spanish/English) for a global biopharmaceutical company located in Summit, NJ and Tampa, FL. This position also has remote capability. This is a 1+ year contract. Job Title: Bilingual RECRUITER (Spanish/English – fluent reading/writing/speaking) Duration : One year from start date Typical Daily Work Hours : Mon-Fri, 40 Hrs/Wk, 8am to 5pm (some flexibility in daily start/end times) Weekend & OT work : Very rare, but candidates should be open to it if needed Onsite (at Summit NJ or Tampa FL) or remote candidates. We are seeking an experienced, successful recruiter who will be a member of the Talent Acquisition team. They will be a key driver to proactively deliver on fulltime hiring needs within the business/functional areas they support. They will have responsibility for managing the end to end recruiting process from the Recruiting Strategy meeting, to posting, screening until the offer has been accepted. This will happen in collaboration with the Hiring Manager and HRBP. Responsibilities include: • Set expectations in the Recruiting Strategy meeting as to roles and responsibilities of the hiring manager and HRBP . • Recruiter will be responsible for providing quality candidates to the hiring manager & HRBP, timeliness of their presentations, while providing updates throughout the interview process • Will manage relationships with third party vendors (if engaged) • Provide recruitment status updates to the Hiring Manager and HRBP • Champion structured interviewing and selection methodology / approach with client group • Screen candidates • Prior to onsite interviews, the recruiter will prepare the candidate for their interview day • Manage candidate debrief sessions following the interviews – communication with the candidate throughout the interviewing process. • Work with the HRBP in order to put forward a competitive offer package – with input from the hiring manager Prerequisites: • BA/BS degree in a concentration related to business, marketing, or life sciences required or equivalent experience • Five (5)+ years of successful recruiting experience in Pharma/Biotech industry Skills/Knowledge Required: • Bachelor’s degree preferred • MUST BE fully Fluent in English and Spanish (speaking, reading and writing) • Demonstrated experience/interface with senior level management and business partners • Proficient in using an ATS – Taleo preferred • Superior communication skills, both written and verbal • Ability to work independently on multiple concurrent tasks. • Ability to appropriately handle highly confidential information. • Ability to work with limited day-to-day supervision 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

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.

Software Engineering Manager (Relocation Assistance Provided)

Software Engineering Manager (Relocation Assistance Provided) Based in Austin, TX, 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 Software Engineering Manager who will lead the development of our cloud-based software product, our customer applications, as well as our internal laboratory information management system. If you would like to lead and mentor a distributed engineering team, and handle high-level architectural design, 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 The Software Engineering Manager will lead project development on our cloud-based software application as well as our internal Laboratory Management System. This role includes leadership and mentorship of a distributed engineering team, high-level architecture design, project management and professional communication responsibilities on high impact, high visibility products. – Provide technical leadership to software development engineers, both onsite and remote, to ensure software development efforts meet corporate objectives. – Act as project manager for large software development projects: – Identify project objectives, the scope of software deliverables, external dependencies, resources, and framework for the project activities. – Oversee collaboration among cross-functional project teams of developers, software quality engineers, and product managers. – Mediate conflicts, evaluate project performance, bring the project to a close, and capture the lessons learned. – Lead the technical design, architecture, and implementation strategy development, assure the use of the best engineering practices. – Provide feedback to management and promote changes to optimize software development processes with a focus on quality, innovation, and efficient product delivery – 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. – Provide systematic and direct individual performance feedback focused on recognition of achievement and opportunities for growth. – Build and maintain strong and effective relationships with internal and external stakeholders. What You Need for this Position – 2+ years leading, building, and managing an engineering team – Experience leading geographically distributed/remote teams – 4+ years of software development using Java – Architecture design – Experience in the biotech/healthcare domain (experience in a regulated environment/HIPAA) – Bonus skills or experience: – AWS – Docker – Jenkins – Modern JS frameworks (React/ Angular/ Vue/ etc.) & UI frameworks – Healthcare, Genetics, Biotech industry (LIMS, LIS, LES, or ELN – LabVantage) What’s In It for You 1. Salary ($160k – $180k) 2. Bonus 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 14. Relocation assistance provided for non-local candidate So, if have a strong Java background and experience leading an engineering team, 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.

Sr. Software Engineering Manager (Biotech/Healthcare Experience)

Sr. Software Engineering Manager (Biotech/Healthcare Experience) 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 Sr. Software Engineering Manager who will lead the development of our cloud-based genetics data analysis pipeline and our internal laboratory information management systems (LIMS). If you would like to lead and mentor a distributed engineering team, handle high-level architectural design, influence the organizational and technical changes, and be initially 30% – 40% hands-on, 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 The Sr. Software Engineering Manager will lead project development on our cloud-based software application as well as our internal Laboratory Management System. This role includes leadership and mentorship of a distributed engineering team, high-level architecture design, project management and professional communication responsibilities on high impact, high visibility products. This person will be 30-40% hands-on initially. – Provide technical leadership to software development engineers, both onsite and remote, to ensure software development efforts meet corporate objectives. – Act as project manager for large software development projects: – Identify project objectives, the scope of software deliverables, external dependencies, resources, and framework for the project activities. – Oversee collaboration among cross-functional project teams of developers, software quality engineers, and product managers. – Mediate conflicts, evaluate project performance, bring the project to a close, and capture the lessons learned. – Lead the technical design, architecture, and implementation strategy development, assure the use of the best engineering practices. – Provide feedback to management and promote changes to optimize software development processes with a focus on quality, innovation, and efficient product delivery – 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. – Provide systematic and direct individual performance feedback focused on recognition of achievement and opportunities for growth. – Build and maintain strong and effective relationships with internal and external stakeholders. What You Need for this Position – BS or MS in Computer Science or equivalent industry experience – Working experience in the Healthcare, Diagnostics (Genetics), and/or Biotech industry (LIMS, LIS, LES, ELN, NGS) – 3 to 8 years leading, building, and managing an engineering team – Strong leadership skills – 5+ years of software development experience using Java – Experience leading geographically distributed/remote teams – Architecture design – AWS – Bonus skills or experience: – Docker – Jenkins – Modern JS frameworks (React/ Angular/ Vue/ etc.) & UI frameworks What’s In It for You 1. Salary ($175k – $205k) 2. Bonus – 15% 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 have a strong Java background and experience leading an engineering team, 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.

Software Engineering Manager (Biotech/Healthcare Experience)

Software Engineering Manager (Biotech/Healthcare Experience) 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 Software Engineering Manager who will lead the development of our cloud-based genetics data analysis pipeline and our internal laboratory information management systems (LIMS). If you would like to lead and mentor a distributed engineering team, handle high-level architectural design, and influence the organizational and technical changes, 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 The Software Engineering Manager will lead project development on our cloud-based software application as well as our internal Laboratory Management System. This role includes leadership and mentorship of a distributed engineering team, high-level architecture design, project management and professional communication responsibilities on high impact, high visibility products. – Provide technical leadership to software development engineers, both onsite and remote, to ensure software development efforts meet corporate objectives. – Act as project manager for large software development projects: – Identify project objectives, the scope of software deliverables, external dependencies, resources, and framework for the project activities. – Oversee collaboration among cross-functional project teams of developers, software quality engineers, and product managers. – Mediate conflicts, evaluate project performance, bring the project to a close, and capture the lessons learned. – Lead the technical design, architecture, and implementation strategy development, assure the use of the best engineering practices. – Provide feedback to management and promote changes to optimize software development processes with a focus on quality, innovation, and efficient product delivery – 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. – Provide systematic and direct individual performance feedback focused on recognition of achievement and opportunities for growth. – Build and maintain strong and effective relationships with internal and external stakeholders. What You Need for this Position – BS or MS in Computer Science or equivalent industry experience – Working experience in the Healthcare, Diagnostics (Genetics), and/or Biotech industry (LIMS, LIS, LES, ELN, NGS) – 2+ years leading, building, and managing an engineering team – Strong leadership skills – 5+ years of software development using Java – Experience leading geographically distributed/remote teams – Architecture design – AWS – Bonus skills or experience: – Docker – Jenkins – Modern JS frameworks (React/ Angular/ Vue/ etc.) & UI frameworks What’s In It for You 1. Salary ($165k – $200k) 2. Bonus 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 have a strong Java background and experience leading an engineering team, 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.

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.

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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