Senior Regulatory CMC Scientist (Biologics)
Merck
Merck in the United States is seeking an Associate Principal Scientist, Regulatory CMC - Biologics (R4). This role oversees global regulatory strategies for biologics CMC, prepares and submits CMC sections, and mentors scientists on regulatory content. The position requires at least 10 years of biologics IND/BLA/post-approval experience, strong leadership, and collaboration across cross-functional teams to ensure timely submissions and product supply. #J-18808-Ljbffr Merck
$117k - $184.2k
Job DescriptionSENIOR SCIENTIST (R3) REGULATORY CMC - SYNTHETIC MOIETIES OF ADCs AND BIOCONJUGATESPosition Description:Serve as a Regulatory Chemistry... ..., Investigational Medicinal Product Dossiers, original Biologics License Applications, Marketing Authorization...SeniorRegulatoryFull timeFor contractorsLocal area- Scorpion Therapeutics is seeking a Senior Scientist (R3) in Regulatory CMC Biologics to lead global regulatory strategies across development and post-approval for biologics products. You will develop and execute robust CMC regulatory plans, manage INDs, BLAs, and post-approval...Regulatory
- Role Senior Scientist (R3) Regulatory CMC focusing on synthetic moieties of ADCs and bioconjugates, providing regulatory leadership across product development and lifecycle. Responsibilities develop and implement global regulatory CMC strategies for drug-linkers, payloads...SeniorRegulatory
$117k - $184.2k
...enthusiastic individual to join our Rahway, NJ team as a Senior Scientist (R3) in Biologics Analytical Research & Development (AR&D) GMP Operations... ..., Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical challenges, provide scientifically...SeniorRegulatoryFull timeFor contractorsLocal areaVisa sponsorshipFlexible hoursAfternoon shift$117k - $184.2k
...Senior Scientist role leading regulatory chemistry, manufacturing, and control strategy for synthetic components of antibody-drug conjugates and bioconjugates... ...collaboration. Responsibilities Lead regulatory CMC strategy for synthetic moieties of assigned ADC and...SeniorRegulatory$117k - $184.2k
Job Description Senior Scientist (R3) REGULATORY CMC BIOLOGICS Position Description Serve as a Regulatory Chemistry, Manufacturing and Control (CMC) Project Lead and provide CMC leadership within Regulatory and on cross-functional teams for the assigned biological projects...SeniorRegulatoryFor contractorsLocal areaFlexible hours$190.8k - $300.3k
Job DescriptionDescriptionThe Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison reports to the Executive Director or Associate Vice President... ...or more company investigational and marketed drugs/biologics. This position requires a leader with a strategic...SeniorRegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours- Job Description Description The Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison reports to the Executive Director or Associate Vice President... ...global studies related to investigational drugs/biologics. Participates in regulatory due diligence...SeniorRegulatoryLocal areaWorldwide
$142.4k - $224.1k
Job DescriptionThe Biologics Analytical Research & Development department of our Research... ...applicants for an Associate Principal Scientist position available at its Rahway, New Jersey... ...technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific...RegulatoryFull timeFor contractorsLocal areaFlexible hours$117k - $184.2k
Job DescriptionOur Research Scientists are our Inventors. Using innovative thinking, state-of-the-art facilities, and robust scientific... ...methodology, we partner to deliver the next medical breakthrough.Biologics Process Research & Development (BPR&D) within our Research &...SeniorFull timeFor contractorsLocal areaFlexible hours$117k - $184.2k
...oral dosage forms (injections, implants, inhaled, ocular) for biologics, mixed modalities, vaccines and small molecules from preclinical... ...and conclusions in formulation development reports and regulatory filings. Active participation and leadership on formulation development...SeniorRegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...Merck seeks a Senior Scientist for Biologics Process R&D to develop innovative manufacturing processes and technologies for biotherapeutics. The role involves upstream and/or downstream bioprocessing, experimental design, and cross-functional collaboration within the...Senior
- Scorpion Therapeutics in Rahway, NJ invites a Senior Scientist (R3) to lead Regulatory CMC activities for synthetic moieties of ADCs and bioconjugates, guiding product development through lifecycle. You will develop global CMC strategies for drug-linkers, payloads, and...Regulatory
- Merck & Co. is seeking a Senior Director (Sr. Principal Scientist) to lead the planning and direction of clinical research for oncology medicines. This... ...study design, placement, monitoring, analysis, regulatory reporting, and publication across all development phases...SeniorRegulatory
$282.2k
Job DescriptionThe Senior Clinical Director (Senior Principal Scientist) has primary responsibility for the strategic planning and directing clinical research... ..., initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Clinical...SeniorRegulatoryFull timeFor contractorsLocal areaVisa sponsorshipFlexible hours$282.2k
...colleagues while developing and expanding your career. The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and... ...including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior...SeniorRegulatoryFull timeFor contractorsLocal areaFlexible hours$190.8k - $300.3k
...Therapeutic Area Leader (TAL) is a senior scientific leader responsible... ..., a deep understanding of regulatory expectations for immunology... ..., Compound Leaders, and scientists across NDS and/or Preclinical... ...medicine, clinical development, and CMC.Demonstrate situational...SeniorRegulatoryFull timeFor contractorsLocal areaFlexible hours$117k - $184.2k
Job DescriptionSenior Scientist, Statistical Programming - Rahway, NJ:Provide support to statistical programming activities for late-stage... ...of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.Design and...SeniorRegulatoryFull timeFor contractorsLocal areaVisa sponsorshipFlexible hours- ...Develop, validate, optimize, and verify analytical chromatographic methods in accordance with ICH, USP, FDA, and other applicable regulatory requirements. Create and execute validation protocols, method transfer protocols, technical reports, and supporting...SeniorRegulatoryContract workWork at office
$117k - $184.2k
Job DescriptionJob DescriptionThe Senior Scientist, Device Design Control Lead, is a crucial member of our team, responsible for spearheading... ...for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness.Lead the implementation...SeniorRegulatoryFull timeFor contractorsLocal areaFlexible hours$117k - $184.2k
...candidate will join a group of innovative scientists with broad deliverables ranging from API... ...and Operationalizing Quality goals. The Senior Scientist position is a laboratory-based... ...reports, experimental designs, regulatory submission documents, etc.Perform investigations...SeniorRegulatoryFull timeContract workFor contractorsLocal areaFlexible hours$173.2k - $272.6k
...molecules, peptides, and biologics from preclinical... ...This role is a Principal Scientist-level technical leadership... ...-Clinical, Quality, Regulatory, Manufacturing, and... ...mitigationContribute to CMC regulatory submissions... ...skills at the senior/principal levelPreferred...RegulatoryFull timeFor contractorsLocal areaFlexible hours$190.8k - $300.3k
...Senior Principal Scientist in Regulatory Affairs at Merck responsible for developing and implementing worldwide regulatory strategies for General Medicine and Immunology programs. The role involves independent project management, direct agency interactions, and leadership...SeniorRegulatoryWorldwide$117k - $184.2k
...Senior Scientist, Statistical Programming role supporting late-stage clinical development and regulatory submissions for drugs and vaccines. Responsible for developing statistical analysis datasets, tables, and figures while collaborating with cross-functional teams throughout...SeniorRegulatory$117k - $184.2k
...objectives.Accountable for managing any study specific partners and/or vendors.Core Skills:Solid knowledge of clinical research regulatory requirements (e.g., Good Clinical Practice (GCP) and International Council for Harmonisation (ICH)).Ability to manage multiple competing...SeniorRegulatoryFull timeFor contractorsWork at officeLocal areaFlexible hours$117k - $184.2k
...Senior Scientist leading device design control activities for combination product development at Merck. Oversees regulatory compliance, cross-functional collaboration, and design control implementation throughout the product lifecycle in a hybrid New Jersey role. Responsibilities...SeniorRegulatory- ...Senior Scientist Statistical Programming role in late-stage clinical development supporting drug and vaccine programs. Responsible for designing... ...leading programming teams across global clinical trials and regulatory submissions. Responsibilities Develop and validate...SeniorRegulatory
- ...Principal Scientist role leading long-acting injectable... ...molecules, peptides, and biologics. Provides technical... ...with clinical, quality, regulatory, and manufacturing teams... ...functional teams and mentor senior-level scientists Working knowledge of CMC regulatory expectations...Regulatory
$117k - $184.2k
...Senior Scientist position in Supply Analytical Sciences at Merck's Rahway facility. The role involves analytical chemistry work for API... ...development, including method development, troubleshooting, and regulatory support within a multidisciplinary team. Responsibilities...SeniorRegulatory- ...Senior Principal Scientist leading global medical affairs strategy for head and neck cancers and melanoma. Coordinates scientific planning, life cycle management, regulatory engagement, and oversight of regional medical affairs teams across oncology. Responsibilities...SeniorRegulatory
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