Senior Scientist, Regulatory Affairs- CMC - Synthetic Moieties of ADC's and Bioconjugates

Position Description:

• 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.
• 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

Position Qualifications:

• 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. 

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Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.