Senior Scientist, Regulatory Affairs- CMC - Synthetic Moieties of ADC's and Bioconjugates
Merck
Summary
Serve as a Regulatory Chemistry, Manufacturing and Control (CMC) Lead for the synthetic-moiety (Drug-Linker) of assigned antibody-drug conjugate (ADC) and other bio-conjugate programs, providing regulatory leadership within Regulatory and on cross-functional teams.
Job description
Be accountable for the delivery of all regulatory milestones through product development and post-approval lifecycle.
Develop and execute robust, phase-appropriate global Regulatory CMC strategies for drug-linkers, payloads, linkers, peptides, and other chemically synthesized moieties that are part of bio-conjugate molecules.
Be accountable for the execution of global product regulatory strategies by robust assessment of global regulatory CMC requirements and identification of potential risks.
Integrate the regulatory strategy for synthetic moieties with those for the targeting component, conjugation process, conjugated drug substance, and drug product, including alignment of dossier content, data requirements, and regulatory milestones.
Manage preparation and execution of Chemistry, Manufacturing and Control documentation including Investigational New Drug Applications, Investigational Medicinal Product Dossiers, original Biologics License Applications, Marketing Authorization Applications, post-approval submissions/variations, agency meeting background packages, and responses to health authority questions.
Manage change controls and develops regulatory filing strategies with an understanding of regulations and company policies and procedures.
Conduct all activities with an unwavering focus on compliance.
Requirements
- B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemistry, Chemical Engineering, or Biochemistry.
- At least 5 years of Regulatory CMC or directly relevant pharmaceutical development experience in small molecules or other chemically synthesized modalities, including experience in process chemistry, analytical development, manufacturing, testing, quality, technical operations, or CMC product development.
- Experience supporting CMC regulatory submissions, health authority interactions, or development of drug-linkers, payloads, ADCs, peptides, oligonucleotides, or other bio-conjugate or new-modality products.
- Experience with external development or manufacturing partners and global life-cycle management is also preferred.
- Adaptability
- Analytical Biochemistry
- Analytical Chemistry
- Antibody Drug Conjugates (ADC)
- Biochemistry
- Bioconjugation
- Chemistry
- Detail-Oriented
- Document Coordination
- Drug Development
- Drug Formulations
- Electronic Common Technical Document (eCTD)
- Employee Training Programs
- External Manufacturing
- Interpersonal Relationships
- Ligand Binding
- Pharmaceutics
- Process Chemistry
- Regulatory Affairs Management
- Regulatory CMC
- Regulatory Communications
- Regulatory Compliance
- Regulatory Compliance Audits
- Regulatory Documents
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Other Insurance Benefits
- 401(k)
- Retirement Benefits
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Leave
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.