- Merck & Co. (Rahway, NJ)
- Job DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development ... techniques to positively support and influence clinical and commercial combination product development and launches.Principal Responsibilities: Lead and set… more
- Merck & Co. (Rahway, NJ)
- …Pilot Plant Operations, Process Engineering , Process Optimization, Product Formulation, Protocol Development , Quality Management, Regulatory Inspections, ... Job DescriptionThis Engineer position will provide engineering support of the Rahway, NJ FLEx (Formulation,...critical program needs related to new products undergoing process development , new products undergoing scale-up, launch and transfer to… more
- Insmed Incorporated (NJ)
- …of the Technical Operations leadership team and contribute significantly to our overall product development strategy.You'll lead both drug substance (API) ... are seeking a highly experienced and visionary Vice President, Product Development - CMC, Small Molecules, to...diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and Controls (CMC) activities for… more
- Insmed Incorporated (NJ)
- …Are you?About the Role:We are seeking a highly experienced and visionary Vice President, Product Development - CMC, Gene Therapy and Large Molecules, to help us ... therapies to patients.What You'll Do: As the Vice President, Product Development - CMC, Gene Therapy and...timelines and quality standards.This position offers the opportunity to lead cutting-edge gene therapy development while building… more
- Merck & Co. (Rahway, NJ)
- …through influence, advocacy, & negotiation with stakeholders. Influences and challenges the product development team's strategy to ensure a robust CMC strategy ... work environment Preferred Experience and Skills: Experience in ADC development and commercialization.Experience in Technical product stewardshipDemonstrated… more
- Repligen (Waltham, MA)
- …and driven IT Business Partner to represent our Manufacturing, Quality, Supply Chain, Product Development , and R&D organizations. As a Director of IT, you ... efficiency, and enabling innovation across the bioprocessing manufacturing and product development lifecycle.This position requires strong collaboration with… more
- Merck & Co. (Durham, NC)
- …Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development , Technical Services, Utilities and Validation.The Maurice R. Hilleman ... for commercial technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to… more
- Merck & Co. (Rahway, NJ)
- …Experience: Subject matter expertise in packaging and/or medical device and combination product components as well as development and qualification of package ... mission. The successful candidate will possess deep packaging and/or combination product technical expertise, a strong track record in problem-solving, strategic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for the management, development , and performance of all engineering operations across Raritan Carvykti drug product manufacturing. This role ... response to unexpected issues are critical for this leader.Key Responsibilities Lead and oversee all engineering management including asset/reliability, data… more
- Merck & Co. (Rahway, NJ)
- …our team, responsible for spearheading risk management efforts in combination product development , commercialization, and lifecycle management. This individual ... requires extensive collaboration with subject-matter experts across various cross-functional combination product development teams throughout all phases of the … more
- Lundbeck (Bothell, WA)
- …Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development ... us on our journey to advance brain health and transform lives.Summary:The Team Lead , Downstream Process Development , is responsible for leading and managing the… more
- Twist BioScience (South San Francisco, CA)
- …our commercial and scientific operations. We're seeking a Senior Staff Technical Product Owner to lead complex, cross-functional projects with minimal oversight, ... Sr Staff Technical Product Owner (Hybrid in South San Francisco, CA...requirements.What You'll DoAs a senior, highly autonomous contributor, you'll lead complex high-visibility initiatives that span multiple systems and… more
- Merck & Co. (Durham, NC)
- …support of regulatory and customer inspections Provide compliance advice to site, development and commercial product teams Supports and continually enhance the ... Job DescriptionThe Quality Associate Director/GMP Lead Site Auditor will have leadership responsibility for the site internal audit program, encompassing the full… more
- Merck & Co. (Rahway, NJ)
- …This position has a multiple roles including leveraging experience in drug product manufacturing to perform daily manufacturing operations ( development & GMP) ... to drive pre-FLEx manufacturing deliverables. Support in preparation and manufacture of development and GMP drug product batches Oversee inventory management and… more
- Cipla (Fall River, MA)
- …the safe and efficient execution of their job duties, while ensuring product compliance to established standards. Essential Duties and Responsibilities : Performing ... but serviceable repair parts. Prepare for operation, maintenance and engineering procedures of all equipment. Follow procedure as per...believes that our biggest assets are the employees, who lead us to prosperity and growth in the future.… more
- Bayer (Myerstown, PA)
- …quality and cost improvement programs. Also, responsible to support the Packaging Development team to lead innovative packaging solutions that deliver packaging ... Packaging Development Scientist IV At Bayer we’re visionaries, driven...YOUR TASKS AND RESPONSIBILITIES Implement new package designs for product launches, ensuring compatibility with packaging line equipment and… more
- Cipla (Fall River, MA)
- …readiness. Responsible for collaborating with Cipla global stakeholders particularly Integrated Product Development (IPD) and Quality Assurance (QA) to ... functions on assumptions, risks and market developments leading to development of commercial models. Lead and implement...project management training is a plus. Experience Experience with product development process as applied to 505(b)(1)… more
- Merck & Co. (Rahway, NJ)
- … Engineering , Combination Products, Device Development , Process Development Engineering , Process Improvements, Product DevelopmentPreferred Skills: ... individual will be expected to apply his/her knowledge of product development and design control principles to...remediation plans and drive their execution through to closure. Lead /contribute to device development , design controls for… more
- Bayer (Myerstown, PA)
- …success criteria, Target Product Profile (TPP), and contingency plansfor development activities. Lead development of critical process parameters.Provide ... Engineering , Pharmaceutical Sciences), or international equivalent;Good understanding of product development processes, critical process parameters, and… more
- Aptyx (Charlotte, NC)
- …Engage and handoff activities to manufacturing engineering Support customer complaints Lead design changes to existing product lines as necessary Review ... Engineer position performs the function of design engineer for product development work on medical devices in...The primary role of an R&D Engineer is to lead project deliverables and lead technical reporting… more
