- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... - Quality Network Leader, Chromatography & Proteins.ResponsibilitiesThe Director , Quality will be responsible for:Maintaining site compliance to ISO 9001… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop ... / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound...and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director … more
- Merck & Co. (Durham, NC)
- …to align to SAP and business processes related to any new project implementations. Site supply chain lead and coordinator for the successful implementation of ... warehousing and logistics operations, both on the main campus as well as off- site (3rd party) storage facilities.- The successful candidate will be responsible for… more
- Merck & Co. (Rahway, NJ)
- …with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support ... Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a key leadership...global and site -specific projects, facilitate technology transfer, and drive product robustness… more
- Merck & Co. (Durham, NC)
- … Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer, Develop and Execute Manufacturing ... Mindset - Demonstrated ability to deliver compliant supply and achieve highest quality , lowest cost, and shortest lead -time. Strategic Thinking - Ability… more
- Merck & Co. (Rahway, NJ)
- …portfolio of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for… more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) ... enabled combination products to achieve safe and effective delivery to their intended site of action.- The DD&T Team manages the development of the device… more
- Merck & Co. (Rahway, NJ)
- …Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and communication ... its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the… more
- Merck & Co. (Upper Gwynedd, PA)
- …Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... include, but are not limited to:Regulatory Responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory… more
- Merck & Co. (San Francisco, CA)
- …data-driven decision-making. Under the broad guidance of the DSCS Digital Program Mgmt Lead , the Associate Director , DSCS Digital Project Manager, will be ... Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS)… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of a HEDS Executive Director , the Senior Principal Scientist, Health Economics leads a team of health economists and outcomes ... and payers in order to optimize market access and patient outcomes.Main Responsibilities: Lead a team in HEDS to develop and implement health economic models and… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision ... leverages external expertise in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to … more
- Lundbeck (TX)
- …brain disease. Join us on our journey of discovery! POSITION SUMMARY: The Director , Chemical Biology leads a world-class team researching new understandings of the ... oversees their progression to early milestones Leads the design and synthesis of high- quality small molecule tools and early hits Working closely with project teams,… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the ... to: - - Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality… more
- Repligen (Clifton Park, NY)
- …for harmonization for matrixed roles. Lead all operations at the site , including Planning, Procurement, Manufacturing, Distribution, Engineering, Quality and ... . The successful candidate will play a key role in delivering the site expansion programs, implementing quality management systems and maintaining ISO… more
- Merck & Co. (Rahway, NJ)
- …Principal Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in ... in integrated analytical control strategy development and execution. Demonstrated ability to lead a technical team and develop talent through good mentoring skills.… more
- Merck & Co. (North Wales, PA)
- …clinical/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring ... clinical data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the development of Protocol… more
- Merck & Co. (Rahway, NJ)
- …execution of clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team ... clinical data/medical protocol deviations in collaborations with the Clinical Director . Other responsibilities include: Collaborating cross-functionally in the development… more
- Bristol Myers Squibb (Devens, MA)
- …(BI&T)- BioPharma Operating Units, the Sr. Director , BI&T, Devens Digital Plant and Site BI&T Lead will be directly accountable to the US Biologics Leader ... be a standing member of the Devens Campus leadership team. **Key Responsibilities:** + Lead a matrixed organization composed of both site direct reports and… more
