- Daiichi Sankyo, Inc. (Bernards, NJ)
- …specifically for specialty pharmacy, REMS, co-partners and affiliates. Liaise with Audit and Compliance team to ensure that Global Medical Affairs audits are ... designated programs.Ensure proactive representation of Quality professionals at strategic non-project team and at MA strategic discussions. Lead the Quality… more
- Merck & Co. (Rahway, NJ)
- …candidates from development to launch in line with enterprise priorities.-As the DCT leader , the Technical Product Leader (TPL) in our Manufacturing Division ... target commercial product.-Leads the cross-functional DCT, critically assessing all team deliverables & fostering a learning and collaborative environment.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description The Development and Commercialization Team (DCT) leader is-accountable for delivering a fully-integrated stage-appropriate CMC ... advancing the company's Antibody Drug Conjugate (ADC) portfolio. Correspondingly, the DCT leader will be responsible for delivering world class outcomes in the… more
- Merck & Co. (Boston, MA)
- …publication, and presentation at national and international meeting.-They will lead cross-functional product development teams that oversee program strategy and ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team of Validation Leads ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Merck & Co. (Rahway, NJ)
- …The Associate Director position's core responsibilities are to oversee our Company's compliance related to customs country of origin. In the origin space, ... are to oversee our company's customs country of origin program and lead efforts related to global customs origin reviews. CIT is primarily responsible… more
- Merck & Co. (Rahway, NJ)
- …Development (AR&D) Associate Principal Scientist to serve as a Device Analytical Lead supporting medical device and combination product (MDCP) programs at various ... MDCP programs, serving as a key member of the Combination Product Analytical sub- team within the Combination Product Working Group. -The Device Analytical Lead … more
- Merck & Co. (Rahway, NJ)
- …assurance. -The primary responsibility of the Deputy Chief Privacy Officer is to lead the team responsible for internal and external stakeholder engagement, ... working in close partnership with the operations lead .Specific responsibilities include:Oversee the team of Regional Privacy Leads and privacy professionals who… more
- BioAgilytix (Durham, NC)
- …and Future Team Development:Work closely with IT, lab operations, and quality/ compliance teams to ensure alignment on data goals and processes.Act as an advocate ... the technical heavy lifting yourself while laying out the roadmap for a future team .Just as important, you'll own the last mile: turning those clean, validated data… more
- Merck & Co. (San Francisco, CA)
- Job DescriptionAssociate Principal Scientist, General Medicine Therapeutic Areas Biomarker Lead Job DescriptionTranslational Biomarkers (TB) is responsible for the ... is seeking a highly motivated candidate to join our team . The individual will play a critical role in...implement biomarker strategies for early and late-stage clinical programs. - Lead clinical biomarker sub-teams as part of program development… more
- Novo Nordisk Inc. (Boulder, CO)
- …of both worlds to develop new medicines for patients. The Position The Technical Team Lead , API Manufacturing works in Novo Nordisk's Boulder, Colorado Pilot ... to ensuring the supply of API and meeting production goals, the Technical Team Lead actively supports continuous improvement initiatives and identifies wherever… more
- Merck & Co. (Rahway, NJ)
- …the data, add new fields, organize data, visualizations in Power BI, and ensure compliance within SPDWorking closely with SPD leadership team to map resources to ... to partner with the Sterile Product Development (SPD) leadership team to support the strategy and operations of the...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Durham, NC)
- …and Computerized Maintenance Management Systems.Demonstrated ability to work independently as a team leader and team member.Demonstrated ability to motivate ... and proper documentationSupport safety programs (LOTO, HECP, etc.) and environmental compliance from a maintenance perspective.Ownership of the Leader … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …seeking a Contamination Program Lead as part of the Technical Operations team based in Raritan, NJ.Role OverviewThe Contamination Program Lead will be ... / Annex 1 requirements. This person will be the lead for contamination program, working cross functionally with various...integral part of the CAR-T Environmental Monitoring Immediate Action team and Contamination Rapid Response Team in… more
- Repligen (Clifton Park, NY)
- OverviewThis position is for a Production Lead in the Repligen Injection Molding and Packaging manufacturing group. The lead will be responsible for the safe ... responsible for leading the day-to-day activities of the manufacturing team . In addition, this role will be required to...addition, this role will be required to assign, track, lead , and plan orders to completion to the production… more
- Repligen (Clifton Park, NY)
- OverviewThe Extrusion Lead will report to the Extrusion SupervisorResponsibilitiesOperation of a mill to combine starting raw materialsOperation of extruders and ... safety proceduresResponsible for area cleanliness and inspection readinessAbility to hold team accountable for production, safety, and quality.Ability to lift 50lbs,… more
- Repligen (Waltham, MA)
- …a team of regulatory subject matter experts. The Regulatory Affairs team will monitor external product compliance requirement and advise the business ... Senior Director Global Regulatory Affairs must have the ability to: Lead & develop a team of Regulatory... of Regulatory subject matter expertsInstall a continuous Regulatory compliance monitoring program leveraging direct team member… more
- Merck & Co. (Rahway, NJ)
- …Supply Chain Working Group (SCWG) for pipeline products or Value Chain Management Team (VCMT) for commercial productsSupport and/ or lead commercial siting ... VCM Product Manager (PM) works under direction of the VCM Product Leader supporting the development and execution of end-to-end (E2E) product supply strategies… more
- Merck & Co. (Durham, NC)
- …to provide area/process overview information to visitors/auditors upon requestQuality & Safety Compliance Foster strong safety culture on the team through ... Required Willingness to work a flexible schedule covering various shiftsDemonstrated ability to lead a team (ie experience leading directly as a supervisor/coach… more
- Merck & Co. (North Wales, PA)
- …- Primary Activities include but are not limited to: - - Data Centric Submissions: Lead the data submissions team that is accountable for the on-time, accurate ... RDM) Strategy & Regulatory Data Standards Governance- - Regulatory Compliance and Risk Management for Regulatory Data - Direct...local SOPs- - Data Centric Business System Owner Operations: Lead the regulatory data governance and standards team… more
