Manufacturing Jobs

Project Manager, RAQA

Kelly Services is currently seeking a Project Manager, RA/QA for one of our top medical technology clients located in Mahwah, NJ. Job Title: Project Manager, RA/QA Location: Mahwah, NJ 07430 Type: Temporary Length: 6-Months Est. Start Date: 3/9/2020 Schedule: Monday – Friday, 8:00 AM – 5:00 PM Pay Rate: $70 – $78 per hour Description: Plans, monitors and manages internal projects from initiation through completion. Secures required resources and uses formal processes and tools to manage resources, budgets, risks and changes. Manages projects to ensure on-time completion according to specifications and within budgeted costs. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. This position requires professional mastery of a specialized field of expertise that typically requires a college degree or equivalent. The job requires professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, in order to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 4 or more years’ experience. APPLY TODAY! **Important information : This position is recruited for by a remote Kelly office, not your local Kelly branch. If you have questions about the position, you may contact the recruiter recruiting for this position Robv492@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 ]]

Tax Manager – Remote

Tax Manager – Remote We are the 10th largest accounting firm in Chicago & have proudly served middle market businesses since the early 1900’s. Excellence, unparalleled client service and a customized approach to each clients priorities distinguish us as a trusted resource of each organization we serve. How do we differ for you? If you asked around, our reputation & company culture speaks for itself. Apply & find out for yourself! What You Will Be Doing – High-net worth, C-Corp, S-Corp, Entities – Real-estate, Construction, Manufacturing, Tech Start-up clients – Some Non-profit as well – Client facing services – Mentoring our team of Tax Seniors & Staff – Working directly with the partners to ensure client success What You Need for this Position – 8+ years of post graduate accounting experience – 2+ years as a Tax Supervisor or Tax Manager – CPA is required – BS in Accounting or related field What’s In It for You – Competitive base (130-160) + Bonus – 401K Match – Top of the line medical, dental & vision – Life Insurance – Disability insurance – Generous PTO & Sick Time – Paid Holidays So, if you are a Tax Manager – 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.

High Power Laser Designer

High Power Laser Designer If you are a High Power Laser Designer with FP Laser design experience, please read on! Job Title: High Power Laser Designer – FP Lasers Job Location: Sunnyvale, CA or REMOTE w/ 30% – 40% travel to China Compensation: $150K – $200K+ DOE Backed by multibillion conglomerates, our company is focusing on laser technologies from research and development, custom design, fast prototyping, new product introduction and mass production. Our products including Edge-Emitting Lasers for telecom and consumer market, VCSELs and VCSEL arrays for Datacom and consumer market and Photo Detectors. Our affiliates provide in-house Epitaxy growth, a world-class manufacturing facility and excellent quality in high volume manufacturing. We are rapidly expanding and currently looking to hire an expert High-Power Laser Designer with experience with FP Laser or VCSEL design. Top Reasons to Work with Us 1) Competitive Compensation ($150K – $200K+ base salary plus bonus depending on experience and track record) 2) Competitive Benefits package with bonus and stock incentives! 3) Career growth with a path to management level, leading the local engineering team. 4) Stable environment with a start-up like upside potential (our company falls under the umbrella of a public company with a $17 Billion USD market cap) 5) The opportunity to work REMOTE with 30% – 40% travel to China. What You Will Be Doing – Design and develop epi structures of high-power lasers, specifically Fabry-Perot (FP), and VCSEL to achieve highest performances in terms of optical power, efficiency, wavelength stability, beam angle, modulation speed,reliability, etc. – Data analysis to build correlation between performance and designs. – Failure analysis of issues affecting functionality and performance. – Work closely with internal and external epitaxial engineer, integration engineer, packaging/testing for product development and quality improvement. What You Need for this Position M.S. or Ph.D. in Electrical Engineering or Physics, with 5+ years experience with the following: – Subject matter expert knowledge and substantial experience with current state-of-the-art laser diodes, including semiconductor device physics (gain, cavity design, heterostructure charge transport) and device reliability physics. – Nationally-recognized expertise in laser semiconductor design. – Experience with high power laser diode arrays, laser diode simulation software, laser diode current driver requirements, III-V semiconductor fabrication and materials technologies, and/or optoelectronic component packaging. – Expert communication, facilitation, and collaboration skills necessary to present, explain, and advise senior management and/or external sponsors. Desired Qualifications – High-Power Laser Design – Fabry-Perot (FP) or VCSEL design preferred – Expertise with 600nm – 800nm Diode Lasers – Work experience at Coherent, IPG Photonics, or similar company highly-preferred So, if you are a High Power Laser Designer with experience, please apply today! or send an updated copy of your resume to Mike.Vandenbergh@CyberCoders.com for immediate consideration! – 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 ]]

Regional Sales Manager

Regional Sales Manager If you are a Regional Sales Manager with experience, please read on! Total Comp Earnings Year 1: Roughly a Base of $120-$140K + Variable Comp $55K – $65K… It all depends on experience as well. Car, phone, and travel covered! Top Reasons to Work with Us Headquartered in Houston, TX, we are a top global manufacturer and project engineering operations company in the Oil & Gas industry. What You Will Be Doing The Remote RSM in North Dakota will be responsible for winning new business and developing relationships with key customers and decision-makers in the pipeline installation and EPC (Engineering, Procurement and Construction) market. You will be assigned and managing an Account Executive, Sr. Account Executive and Program Account Manager. What You Need for this Position Required Skills:- Bachelor’s Degree – Oil & Gas Engineering/Manufacturing Industry Experience- 7+ years of experience selling highly engineered products- CRM (salesforce.com HIGHLY preferred)- Miller Heiman- Strategic Business Sales Methodologies- Cold Calling- Ability to travel regionally up to 50% Bonus Skills:- Pipeline or Oil & Gas Engineering, Procurement, Construction or Manufacturing sales experience- Miller Heiman certified or knowledge – Experience working with major exploration and production or midstream companies What’s In It for You – Base + Bonus/Commissions – Base of $120-$140K+ Variable Comp $55K – $65K It all depends on experience as well.- Travel Expenses Covered- Car/phone Allowances- 401K- PTO- Medical/ Dental/ Vision- Excellent company with amazing culture and people! So, if you are a Regional Sales Manager 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.

Remote- Mainframe Developer III

**please note this position will be remote in the US**Required Qualifications: -Experience in Adobe Experience Manager 6.3 –Content authoring via custom AEM components –Asset management, image loading, tagging –Multiple site edits with country specific content -Lite HTML/CSS abilities –Create lists, change sizes, colors, alignment -Knowledge of web design and search engine optimization best practices -Experience with Google analytics and Salesforce.com with the ability to make recommendations -Photoshop experience- Ability to resize, crop, and make edits to images Soft Skills: -Strong communication skills -Strong organizational abilities -Ability to shift priorities promptly Preferred Qualifications: -Experience in Adobe Experience Manager 6.5 Education: -Bachelor’s DegreeEstablished in 1978, NES Global Talent provides a complete range of contract and permanent talent solutions to the Oil and Gas, Power, Construction and Infrastructure, Life Sciences, Manufacturing and IT sectors worldwide. With more than 40 offices in 28 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. Offering far more than a traditional recruitment service, we fully support our contractors while they are on assignment with everything from securing visas and work permits, to providing market leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.

Embedded Software Engineer

Want to join a leader in the Autonomous Vehicle industry in the Silicon Valley area ? (The AV industry will grow to $550 Billion by 2026 !!!) To $160K+. Relo. assistance provided ! The Embedded Software Engineering team is responsible for developing and validating a broad array of safety critical code for our sensor and computer systems. Embedded Software Engineers work with cross functional teams to develop the requirements and software architecture for our embedded systems. They write and test software for microcontrollers and system-on-chip (SoC) devices in the vehicle. And they conduct system integration validation testing with their peers. What Youll Do Deliver RTOS solutions for safety critical embedded software in a robotics + automotive environment. Design software for sensor control, inter processor communications, monitoring, drivers, acceptance testing, and more. Work with other Hardware Engineers to define requirements for hardware systems. Work with other Software Engineers to integrate embedded systems into our autonomy software stack. What We and #x27;re Looking For Degree in Computer Engineering, Computer Science, Electrical Engineering, Robotics or a related field Experience in software development for embedded devices Experience in Low Level Communications Protocols Experience in Bare Metal Product Environments Strong C/C++ programming skills applied to embedded Microcontroller/Microprocessor targets Experience in Memory Constrained Environments Ability to understand PCB schematic and layout documents Experience with debugging tools and methods for embedded targets Quantitative / analytic mindset to probe, test and decompose challenging system problems into root cause issues with strong, detail oriented skills to solve them A record of owning projects successfully and working in a fast paced environment Ability to serve cross functional roles in a young company Good experience writing concise, clear, and detailed engineering documentation Strong presentation and communication skills Experience with communication protocols used in embedded, robotics and automotive industries Prefer candidates with experience developing highly complex hardware systems in robotics, transportation, aerospace, consumer electronics, defense, medical, energy, or similar industries Open to occasional travel to remote offices, test facilities, engineering partners, or manufacturing partners We have a strong emphasis on creating a highly effective team environment. Thus, we seek candidates that can work effectively with others across a broad range of disciplines. We know it takes competitive benefits to fuel a team that works hard and enjoys the challenge. High-quality individual and family health, dental, and vision insurance Competitive compensation packages Employer-matched 401(k) retirement plan Paid parental leave Unlimited vacation Daily catered lunches and snacks Free onsite or adjacent parking Fitness reimbursement Professional development reimbursement

Digital Marketing Specialist

Our Client a technology-driven
global company built on entrepreneurial innovation, integrity, and teamwork. Their
diverse portfolio includes everything from high-performance fabrics and industrial
manufacturing components and may more. Through their product leadership, we’ve
been changing lives and changing industries for more than 50 years. Our client brings together knowledge
and collaborate closely to create and deliver products that solve complex
problems and perform in the most demanding environments. We are looking for an
experienced Consumer Acquisition specialist with expertise in the
Digital Marketing space to join the team. If you are searching for a company
where you can make a difference, then this is the role for you, In this role, You will align with
global consumer engagement strategy and plan, execute consumer acquisition
initiatives in local markets to target and reach new consumers and drive
sign-ups for CRM (consumer relationship marketing) program. The position is ideally
located in DE but open to remote possibility for exceptional candidates on the
east coast Job
Description Responsibilities: Developing
local implementation plan for consumer acquisition strategy and
programmingContributing
to regional editorial meetings and defining requirements for global,
regional and local content development for consumer acquisitionCollaborating
with agency and/or internal resources to develop and deploy content in
digital channelsWorking
closely with paid media agency to plan, execute and monitor paid media
campaigns to reach new consumers and drive traffic to owned propertiesTargeting
and reaching new consumers across offline touch points to drive sign-ups
for CRM programDefining,
setting up and optimizing landing pages on brand website for consumer
acquisitionUsing
social listening to identify new consumers and influencersUndertaking
local analytics to support marketing decision making and to assess the
performance of consumer acquisition initiativesWorking
closely with customer and retail account managers to activate partner
touch points for consumer acquisitionRequirementsUniversity
degree in business administration, marketing, information technology or
similarMinimum
5 years of experience in digital marketing, search, social media, CRM,
referral marketing, preferably with a retail-based e-commerce company or
with an agency Experience
with Google and Facebook ad management tools, certification is a
plus Experience
with content management systems, content organization and translation
managementExperience
with business requirements gatheringPractical
experience with usability testing and conversion optimizationProficiency
with performance measurement, web analytics. Ability to translate data
into actionable strategiesExcellent
organization and planning skills to develop strategies within a team and
successfully roll-out the strategies Skills
to generate and present reports findings and consumer insights to key
stakeholders. Strong
project management skillsExposure
to user experience design, persona development, and consumer journey
mappingPassionate
about digital marketing and paid mediaFluent
in EnglishAbility
to select, steer and partner with external vendors according to specific
goals and deadlines.Knowledge
of the apparel or fabric industry a plusBenefitsThe client offers comprehensive, competitive
rewards in the form of compensation and benefits. Among these are work-life
balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership
Plan, Health & Well-being program with full health plan, and a flexible working
program. You will find a unique culture, diversity, equity, and inclusion
initiatives, and opportunities for growth and development The client is committed to a
drug-free workplace. All employment is contingent upon successful completion of
drug and background screening.There is no Sponsorships for this role at this time.We’re an
equal opportunity employer. All applicants will be considered for employment
without attention to race, color, religion, sex, sexual orientation, gender
identity, national origin, veteran or disability status.”

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

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