- Merck & Co. (Rahway, NJ)
- …a smooth and clear path to successful PPQs and BLAs for the company's pipeline .Champion compliance and safety ; promote a culture of diversity, inclusion, and ... technical leadership and laboratory capabilities in support of late-stage pipeline commercialization and post-market commercial manufacturing support. BDSC supports… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio ... Director, Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety ...Medical Safety will oversee a team of safety physicians and scientists across various regions, offering guidance… more
- Merck & Co. (Rahway, NJ)
- …technical leadership and laboratory capabilities in support of late-stage pipeline commercialization and post-market commercial manufacturing support. BDSC supports ... validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology… more
- Merck & Co. (Durham, NC)
- Job Requirements This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to ... this Pipeline Advertisement you will be submitting your interest to...Biologic, and Vaccine Products. Our team works with a " Safety First, Quality Always" mindset.-As the primary point of… more
- Merck & Co. (Rahway, NJ)
- …diverse and inclusive environment for all. Beyond process development for pipeline biologics, we innovate and build next generation biomanufacturing technologies. ... As an impactful contributor, shape and realize innovation across the Biologics' pipeline , strategy, and scienceAdvance the pipeline by collaborating with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio ... improvement of Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing… more
- Merck & Co. (Rahway, NJ)
- …diverse and inclusive environment. In addition to process development for pipeline biologics, we are focused on innovating and building next-generation ... scientific leader to shape and drive innovation across the Biologics pipeline , strategy, and science.Anticipate and solve scientific and technical challenges across… more
- Merck & Co. (Rahway, NJ)
- …diverse and inclusive environment. In addition to process development for pipeline biologics, we are focused on innovating and building next-generation ... scientific leader to shape and drive innovation across the Biologics pipeline , strategy, and science.Anticipate and solve scientific and technical challenges across… more
- Merck & Co. (Rahway, NJ)
- …closely with team members and partner groups including formulators, engineers, Quality, Safety , and Facilities management to drive overall success and performance of ... the area and clinical pipeline .-Key Responsibilities:Prepares, operates, and cleans equipment and facilities used in clinical development and manufacturing… more
- Merck & Co. (Rahway, NJ)
- …closely with team members and partner groups including formulators, engineers, Quality, Safety , and Facilities management to drive overall success and performance of ... the area and clinical pipeline .-Key Responsibilities:Prepares, operates, and cleans equipment and facilities used in clinical development and manufacturing… more
- Merck & Co. (Rahway, NJ)
- …through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce ... V clinical trials, preparation of progress reports and summaries regarding vaccine safety and efficacy, as well as analysis, interpretation, and reporting of final… more
- Merck & Co. (Rahway, NJ)
- …enhance data monitoring capabilities, and drive excellence in safety , compliance, supply, and productivity.Global Impact:Collaborate with colleagues across ... and clear path to successful PPQs and BLAs for the company's pipeline .Technical leadership: Strong fundamental knowledge and subject matter expertise with mammalian… more
- AUROBINDO (Durham, NC)
- …In addition to several formulations in our product portfolio, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to ... with all regulatory/in-house requirements (may include but not limited to safety , house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when… more
- Genmab (NJ)
- …in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety , Medical, Clinical Pharmacology and Biomarker functions with the above by ... committees, answers to in-house questions related to data quality, safety monitoring, medical questions etc.Performs sponsor oversight of programming activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio ... data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and other vendors to ensure high quality of… more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable ... and will partner with cross-functional development teams to enable pipeline decisions. -The Executive Director, Biologics Analytical Research and Development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio ... TeamsGOMA and Specialty MA Management teamsData Management/ Biostats Clinical Safety and PharmacovigilanceR&DVendors/ CROs/ third partiesHEOR/ RWEEpidemiology Legal and… more
- Novo Nordisk Inc. (Durham, NC)
- …diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies. What we offer you: Leading ... of the QC Laboratory Support of OFP water testing program Follow all safety and environmental requirements in the performance of duties Other accountabilities, as… more
- Tris Pharma (Monmouth Junction, NJ)
- …our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our ... Drug Administration (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health Administration (OSHA) regulations and guidancesAbility to perform… more
- Merck & Co. (Rahway, NJ)
- …and regulatory filings Ensure smooth execution of PPQs and BLAs for pipeline assets Bring deep expertise in biologics DS processing (large molecule products) ... diverse internal and external teams to deliver as One Team Champion compliance, safety , and a culture of diversity, equity, and inclusion Foster transparency and… more
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