Associate Principal Scientist, Regulatory CMC – Biologics, Synthetic Moieties, Drug-Linker, ADCs, Bioconjugates

MSD

. Implement Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for antibody-drug conjugates and other biologics conjugate product franchises .

Posted 9/24/2026full-timeUnited StatesSeniorLead💰 $142,400 - $224,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Regulatory CMC strategies for antibody-drug conjugates and biologics, with a strong focus on compliance and global regulatory requirements. Proven ability to lead cross-functional teams and manage complex regulatory submissions throughout the product lifecycle.

Highest-signal resume keywords

Regulatory CMC LeadershipGlobal Regulatory Strategy DevelopmentIND/IMPD Submission ManagementPharmaceutical Development ExperienceCompliance with Global CMC Guidelines

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory CMCPharmaceutical DevelopmentProcess ChemistryAnalytical DevelopmentQuality AssuranceTechnical OperationsCMC Documentation PreparationRegulatory Filing StrategiesRisk AssessmentChange Control Management

Soft Skills

Effective LeadershipProject ManagementSuperior Communication SkillsInterpersonal SkillsNegotiation Skills

Industry Keywords

Antibody-Drug ConjugatesBiologicsDrug-LinkersPayloadsPeptidesOligonucleotidesBio-ConjugatesHealth Authority InteractionsPost-Approval ChangesGlobal Life-Cycle Management

About the role

Key responsibilities & impact

Implement Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for antibody-drug conjugates and other biologics conjugate product franchises
Serve as Regulatory CMC Lead for synthetic moieties, including drug-linkers, in assigned ADC and bioconjugate programs
Provide regulatory leadership within Regulatory and cross-functional teams
Deliver regulatory milestones through product development and post-approval lifecycle
Develop and execute phase-appropriate global Regulatory CMC strategies for drug-linkers, payloads, linkers, peptides, and other chemically synthesized moieties
Assess global regulatory CMC requirements and identify potential risks
Integrate synthetic-moiety regulatory strategy with targeting components, conjugation processes, conjugated drug substance, and drug product
Align dossier content, data requirements, and regulatory milestones
Manage preparation and execution of CMC documentation for IND/IMPD, original BLA/MAA, post-approval variations, agency meeting packages, and health-authority responses
Manage change controls and develop regulatory filing strategies
Conduct activities with a focus on compliance
Complete detailed global regulatory assessments according to guidelines, policies, and timelines
Collaborate with partner groups on authoring and reviewing submissions
Resolve project issues collaboratively and escalate to CMC leadership as appropriate
Participate in early- and late-development programs and cross-functional efforts to improve CMC content and processes

Requirements

What you’ll need

B.S. in a science, engineering, or related field; fields include Chemistry, Chemical Engineering, or Biochemistry
At least 10 years of relevant experience, or 5 years with an advanced degree
Relevant experience in Regulatory CMC or directly relevant pharmaceutical development in small molecules or chemically synthesized modalities
Experience in process chemistry, analytical development, manufacturing, testing, quality, technical operations, or CMC product development
Proven ability to critically review detailed scientific information and assess technical arguments and supporting data
Superior oral and written communication skills in multicultural settings
Ability to communicate complex issues succinctly and logically
Flexibility in responding to changing priorities and unexpected events
Effective leadership, project management, communication, interpersonal, and negotiating skills
Ability to generate innovative solutions to complex regulatory problems and communicate with key stakeholders
Knowledge of global CMC guidelines regarding IND/BLAs or post-approval changes
Ability to work in compliance with domestic and international regulations and guidance
United States and Puerto Rico residency
Advanced degree preferred
Experience with pre- and post-approval CMC regulatory submissions, health authority interactions, drug-linkers, payloads, ADCs, peptides, oligonucleotides, bio-conjugates, or new-modality products preferred
Experience with external development or manufacturing partners and global life-cycle management preferred

Benefits

Comp & perks

Annual bonus eligibility
Long-term incentive eligibility, if applicable
Medical, dental, and vision healthcare
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate days
Sick days
Hybrid work arrangement
No travel required
No relocation required