- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist , CMC, R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist /Sr Principal ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPrincipal Scientist - Mixed Modalities, Sterile Product DevelopmentThe Mixed Modalities team within Sterile Product Development is responsible for ... products.We are seeking a highly motivated candidate for the position of Principal Scientist (R5) focused on developing parenteral drug products across a range of… more
- Merck & Co. (South San Francisco, CA)
- Job Description Senior Principal Scientist Translational Medicine, Immunology Translational Medicine in our Research & Development Division is responsible for ... point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the… more
- Aequor (East Syracuse, NY)
- Job Title: Scientist , Analytical Sciences & Technology Contract: 12 Months Location: East Syracuse, NY Job ID: 1167 Qualifications Education / Experience / Licenses ... experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired. Experience… more
- Tris Pharma (Monmouth Junction, NJ)
- …Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and Development (R&D) Senior Scientist ... in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs, including reviews/approvals of Change Control Reports (CCRs),… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDevice Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Merck & Co. (Rahway, NJ)
- …Company's Research & Development Division is seeking applicants for a Principal Scientist position available at its Rahway, New Jersey research facility. The ... Principal Scientist is a senior scientific role tasked with working...and transfer using immunoassay techniques.Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for… more
- Merck & Co. (Rahway, NJ)
- …Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist .BPR&D within Research Laboratories is committed to rapidly delivering diverse ... with the scientific community to influence the field.As a Senior Principal Scientist , you will drive various strategic initiatives and translate strategies into-… more
- Merck & Co. (North Wales, PA)
- Job Description Position Description This position is for a principal scientist in biostatistics.-The candidate should have a solid knowledge of statistical ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Principal Scientist .BPR&D within Research Laboratories is on a mission to rapidly deliver diverse ... and engage with the scientific community to influence the field.As a Principal Scientist you will have the opportunity to influence the future direction of Upstream… more
- Merck & Co. (Boston, MA)
- …in West Point, PA is seeking a highly motivated Associated Principal Scientist with wide knowledge of pharmacokinetic (PK) and toxicokinetic (TK) principles and ... and definitive/Good Laboratory Practice (GLP)], serving as a contributing scientist /principal investigator on toxicity studies, and executing PK/TK strategies to… more
- Merck & Co. (Rahway, NJ)
- …responsibility and leadership of internal and external work.The Senior Scientist , Engineering position leverages scientific/technical experience to develop safe and ... lab scales in addition to technology transfer to commercial manufacturing facilities. The scientist will be expected to exhibit a mindset of safety and quality… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director (Principal Scientist ) has primary responsibility for the planning and directing of clinical research activities involving new or marketed ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… more
- Merck & Co. (North Wales, PA)
- …execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (Rahway, NJ)
- …of clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team in review and ... mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) Ability to manage… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as an Associate Principal Scientist /Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant ... cross-functional teams to foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation, ensuring all processes align with… more
- Aequor (Thousand Oaks, CA)
- …is 3 days onsite per week. The ideal candidate is a Data Scientist with a strong engineering background, preferably in Mechanical, Biomedical, or Chemical ... software-focused backgrounds, are not a fit for this role.The Digital Data Scientist will support the Combination Product Operations organization by improving the… more
- BioAgilytix (Durham, NC)
- …need them.Our Liquid Chromatography/Mass Spectrometry (LC/MS) team is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator ... completion.Additional Responsibilities:Other duties as neededMinimum Preferred Qualifications - Education/Experience ( Scientist III):Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology,… more
- Formation Bio (New York, NY)
- …treatments to patients faster and more efficiently.About the PositionAs a Principal Data Scientist - Medical Imaging at Formation Bio, you will lead our efforts to ... to integrate imaging AI solutions into trial protocols and workflows Partner with regulatory teams to ensure imaging biomarkers and AI models meet FDA standards for… more
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