Associate Principal Scientist Regulatory CMC - Biologics; R4-Synthetic Moieties; Drug-Linker) OF ADCs AND Bioconjugates

Job Description ASSOCIATE PRINCIPAL SCIENTIST REGULATORY CMC - BIOLOGICS (R4)-SYNTHETIC MOIETIES (DRUG-LINKER) OF ADCs AND BIOCONJUGATES

This Associate Principal Scientist position is equivalent to an Associate Director position.

Under direction from Director/Executive Director, the R4 Scientist is responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's Antibody drug conjugates (ADC) and other biologics conjugate product franchises in accordance with domestic and international regulations and guidance.

• Serve as a Regulatory 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 life cycle.
• 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 CMC documentation including IND/IMPD original BLA/MAA, or Post approval / variations, agency meeting background packages and responses to health authority questions per established business processes and systems.
• Manages change controls and develop regulatory filing strategies with an understanding of regulations and company policies and procedures.
• Conduct all activities with an unwavering focus on compliance.
• In depth knowledge of global CMC guidelines regarding IND/BLAs or post approval changes.
• Completion of detailed, global regulatory assessments according to existing global guidelines and policies and defined timelines.
• Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions.
• Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate.
• Participation in early and late development programs, as well as departmental and cross-functional efforts to improve CMC content or processes may also be required, as needed.

• B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemistry, Chemical Engineering, or Biochemistry.

• At least 10 years of relevant experience (5 years with advanced degree) 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.
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected…