- Merck & Co. (Rahway, NJ)
- …as combination product stewardship for inline products. The Executive Director will lead multiple functions in the department of approximately 50 employees, spanning ... overall business objectives for launch preparedness and enhanced robustness, regulatory , and compliance requirements of the company.Provide executive leadership and… more
- Merck & Co. (Rahway, NJ)
- …and technical leader with expertise in cell culture development & commercialization to lead a team of approximately 3-5 scientists, who lead multidisciplinary ... process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for ... cluster representative for initiatives at all levels of the organization.Build and lead the team to effectively manage resources ensuring appropriately skilled and… more
- Merck & Co. (Rahway, NJ)
- …in DS manufacturing operations (cell culture and purification) Strong understanding of regulatory requirements and inspection readiness Ability to lead without ... Job Description Lead the Future of Biologics Drug Substance Commercialization!...Provide technical oversight for DS process development, characterization, and regulatory filings Ensure smooth execution of PPQs and BLAs… more
- Merck & Co. (Rahway, NJ)
- …cell bank and working cell bank) manufacturing operationsStrong understanding of regulatory requirementsAbility to lead without authority, build trust, and ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… more
- Merck & Co. (Rahway, NJ)
- …leading squads and maintaining product lifecycle Manage scientific applications and lead squads to build user-friendly scientific data and technology ... in R&D IT brings together product management, engineering, and data science expertise. We enable data , technology...the RaDS Product organization. The position will report to the- Lead of the Disease Biology and PharmTox Product Line.… more
- Merck & Co. (Rahway, NJ)
- …risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen ... challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors.- Conducts options analysis and provides… more
- Merck & Co. (Rahway, NJ)
- …- Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various ... capabilities that touch every aspect of our business processes, systems, and data .The Associate Director will collaborate and interact with cross-function teams to… more
- Merck & Co. (Rahway, NJ)
- …data entry, data review/approval, and author analytical reports or data summaries.Troubleshoot and lead any investigations associated with GMP testing ... Job DescriptionContainer Closure Integrity Testing Lead , Associate Principal Scientist, Analytical Research & Development The Analytical Research and Development… more
- Merck & Co. (Rahway, NJ)
- …HTA/reimbursement agencies and health systems globally. The ability to participate and lead cross-functional teams is a critical part of this role. This position ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programsIn… more
- Merck & Co. (Rahway, NJ)
- …Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics ... different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes by improving… more
- Merck & Co. (Rahway, NJ)
- …to ensure compliance and reduction in workplace Industrial Hygiene risks. Lead global continuous improvement initiatives to improve global Industrial Hygiene ... and consensus standardsAudit Industrial Hygiene records and prepare supporting data for required government, industry and management reports.Evaluate IH trends… more
- Merck & Co. (Rahway, NJ)
- …and Diagnostics, in this role, you will serve as the translational lead on late-stage immunology programs, driving the Precision Medicine objectives in alignment ... be the authority in defining and interpreting the translational experiments and data generated respectively from our clinical trials, and understanding the potential… more
- Merck & Co. (Rahway, NJ)
- …risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen ... aspects and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory , Quality, and Supply Chain from early development through to commercial… more
- Merck & Co. (Rahway, NJ)
- …challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for ... of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by increasing… more
- Merck & Co. (Rahway, NJ)
- …Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering ... Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our… more
- Merck & Co. (Rahway, NJ)
- …Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant Supply: ... Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with External… more
- Merck & Co. (Rahway, NJ)
- …with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of ... understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications.Ability to design, execute… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation, ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
