Senior Regulatory CMC Biologics Scientist

Job DescriptionOur company is seeking a highly skilled Principal Scientist to join our Biologics Process Research & Development (BPR&D) team. As a key member of our team, you will be responsible for designing and developing innovative purification processes for biologics in early- and late-stage development.ResponsibilitiesCollaborate with cross-functional...

Scientist Opportunities at Merck & Company, Inc.We are seeking a collaborative and self-directed learner to join our team of inventors. As a Principal Scientist, Downstream Biologics Process R&D, you will partner with us to deliver the next medical breakthrough.About the RoleThis role is responsible for developing and implementing innovative solutions to...

Job DescriptionPosition Title: Director/ Principal Scientist, Regulatory ComplianceDepartment: Device Quality & RegulatoryBrief Description of Position:This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure regulatory compliance...

Associate Principal Scientist, Global Regulatory Affairs CMCInsight Global is seeking a highly skilled Associate Principal Scientist to join our Global R&D organization. This individual will be responsible for reviewing technical documentation and scientific information to assess change controls. The ideal candidate will have a strong background in API drug...

Job DescriptionThe Regulatory Operations Specialist will be responsible for maintaining US pharma products registrations and providing CVM/FDA support for labeling and chemistry, manufacturing, and controls (CMC) submissions.Main ResponsibilitiesMaintain and update drug listings for new marketed US Pharmaceutical products, including establishment...

Job SummaryThe Quantitative Pharmacology and Pharmacometrics department of Merck & Company, Inc. is seeking a highly skilled Postdoctoral Research Scientist to join our team in Rahway, NJ. As a key member of our research group, you will be responsible for developing and applying quantitative models of biological systems to advance our understanding of...

Job DescriptionMerck Sharp & Dohme (MSD) is a global healthcare leader with a diverse portfolio of prescription medicines, vaccines, and animal health products. We are committed to creating a healthier future for all.As a Senior Principal Scientist, Clinical Research, Gynecological Malignancies, you will play a critical role in the planning and directing of...

Job SummaryWe are seeking a highly skilled Senior Principal Scientist to lead our clinical research efforts in hematology and lymphoma. As a key member of our team, you will be responsible for planning and directing clinical research activities, including study design, placement, monitoring, analysis, and regulatory reporting.Key Responsibilities:Evaluate...

Job SummaryWe are seeking a highly skilled Senior Principal Scientist to join our team in Rahway, NJ. As a key member of our Oncology department, you will be responsible for planning and directing clinical research activities involving new or marketed Oncology medicines.Key ResponsibilitiesEvaluate pre-clinical and translational work to generate early...

Job DescriptionMerck Sharp & Dohme (MSD) is seeking a highly skilled and experienced Senior Principal Scientist to join our Oncology Research team. As a key member of our team, you will be responsible for leading clinical research activities involving new or marketed Oncology medicines.Key Responsibilities:Evaluate pre-clinical and translational work to...

Piper Companies is seeking a highly skilled Clinical Supplies Quality Assurance Specialist to join their team in Rahway, NJ.Key Responsibilities:• Conduct thorough reviews of electronic batch records to ensure compliance with cGMP and SOPs.• Verify clinical supplier specifications, labeling, and storage procedures.• Review electronic records for...

**Job Summary**Merck Sharp & Dohme is seeking a highly skilled Senior Principal Scientist to lead clinical research activities in oncology medicine development. The ideal candidate will have a strong background in clinical medicine and biomedical research, with a proven track record of scientific scholarship and achievement.**Key Responsibilities**Evaluate...

Job Summary:We are seeking a detail-oriented and proactive Business Analyst to support our pharmaceutical company's CMC digitization initiative.This role will focus on optimizing technology transfer processes, enhancing data management, and improving overall efficiency in CMC operations.The ideal candidate will possess a strong analytical mindset, excellent...

We are seeking a skilled Process Engineer to support our CMC digitization initiative for a leading pharmaceutical company in Ireland.The ideal candidate will have extensive experience working in pharmaceutical manufacturing environments, experience with digital transformation, and knowledge of process knowledge management systems (PKM).Technical experience...

Job DescriptionEarly Device Program Strategy and Due Diligence Principal ScientistJob SummaryThe Principal Scientist of Early Device Program Monitoring & Due Diligence will play a pivotal role in leading and coordinating diverse activities between various device and combination product development, discovery, and formulation development teams.Key...

Job Description:We are seeking a skilled Process Engineer to support our CMC digitization initiative for a leading pharmaceutical company in Ireland. The ideal candidate will have extensive experience working in pharmaceutical manufacturing environments, experience with digital transformation, and knowledge of process knowledge management systems (PKM)....

Piper CompaniesWe are seeking a highly skilled QA Specialist, Clinical Finished Goods to join our team in Rahway, New Jersey.ResponsibilitiesReview electronic batch records to ensure compliance with cGMP and SOPsVerify clinical supplier specifications, labeling, and storageReview electronic records for regulatory submissions (IND or CTA)Focus on biologics,...

We are seeking a skilled Process Engineer to support our CMC digitization initiative for a leading pharmaceutical company in Ireland.The ideal candidate will have extensive experience working in pharmaceutical manufacturing environments, experience with digital transformation, and knowledge of process knowledge management systems (PKM).Technical experience...

Piper Companies is currently seeking an experienced QA Clinical Supplies Specialist to join their team in Rahway, NJ. As a QA Clinical Supplies Specialist, you will be responsible for ensuring clinical supplies are in compliance with cGMP and SOPs. Your duties will include electronic batch record review, checking clinical supplier specifications, labeling,...

Zachary Piper Solutions is currently seeking a Quality Assurance Specialist, Clinical Finished Goods for a hybrid-based opportunity to join a multinational pharmaceutical manufacturer bringing forward life-saving medications and vaccines.ResponsibilitiesReview electronic batch records of finished clinical goods to ensure compliance with cGMP and SOPs.Manage...