- 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)
- …commercialization Provide technical oversight for DS process development, characterization, and regulatory filings Ensure smooth execution of PPQs and BLAs ... assets Bring deep expertise in biologics DS processing (large molecule products) Lead planning, execution , analysis, and documentation of cell culture process… more
- Merck & Co. (Rahway, NJ)
- …Implement and sustain technical standardization of best practices across the network. Lead assignment execution against accelerated timelines, in a ... shake flasks, and/or 2-3L bioreactor systems.Expertise in upstream lab scale experimental execution , Design of Experiments (DOE), statistical data analysis and… 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)
- …data entry, data review/approval, and author analytical reports or data summaries.Troubleshoot and lead any investigations associated with GMP testing ... appropriate corrective and preventative actions.Directly contributes to experimental design, execution , and data interpretation for validation studies.Support… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... and trend evaluations, process characterization, new WCB qualification, and regulatory submission authoring, with a focus on standardization across programs.In… more
- Merck & Co. (Rahway, NJ)
- …world class outcomes in the following areas:Responsible for on-time, end-to end execution of DCT deliverables including - robust processes & analytics, an integrated ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... are not limited to:--Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory ,… 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 ... for end-to-end technical product leadership (TPL) and oversight of the on-time execution of DCT deliverables inclusive of robust processes & analytics, an integrated… 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)
- …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)
- Job DescriptionAbout the Role:-As a Technical Lead , you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a ... as required, proactively identifying risks and supporting all phases of execution . Conduct technical due diligence assessments and provide expert consultation on… 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 ... PCR-based assays.Strong background in analytical control strategy development and execution .Demonstrated ability to develop talent through good mentoring skills.Demonstrated… more
- Formation Bio (New York, NY)
- …and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing ... & External Partnerships Partner closely with analytical development, manufacturing, quality, and regulatory teams to ensure seamless execution of CMC plans.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Job Summary: Position sets the vision, direction, and strategy for Data Management globally and ensures execution of the data ... as well as other BDM functions, sets the vision, direction, and strategy for Clinical Data Management globally and ensures execution of the global data … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and associated data collection. Oversees clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug ... and Regulatory Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Review, Data Surveillance, targeted source document verification and targeted source data review. Lead the team to develop and implement metrics including ... other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for the management, performance, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Lead (GCL), if applicable, leads the development and execution of the Clinical Development Plan (CDP). Ensures individual protocols are consistent ... Clinical Development, an organization dedicated to the effective strategy, design, execution , and interpretation of Oncology clinical trials. Position Summary /… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the organization grows and business needs evolve.Ensure the CoE's continuous operational execution and excellence by applying best practices in accordance with ... regulatory requirements and guidelines worldwide, and in alignment with...event in relation to the drug. Ensure all relevant data and findings are incorporated into comprehensive safety reports… more
