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

Job Description SENIOR SCIENTIST (R3) REGULATORY CMC - SYNTHETIC MOIETIES OF ADCs 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: Education Minimum Requirement: B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemistry, Chemical Engineering, or Biochemistry. Required Experience and Skills: 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. Preferred Experience and Skills: 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. Required Skills: Adaptability, 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 {+ 6 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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 . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: <