Job Details
Posted 24 June, 2026
Job Id: 627549
Associate Director, API / Drug Substance MSAT (Small Molecule)
Job Description
Associate Director, API / Drug Substance MSAT (Small Molecule)
Location: United States (Remote)
Travel: Up to 50%
Level: Associate Director
Overview
A leading, innovation-driven biopharmaceutical organization is seeking an Associate Director, Drug Substance MSAT to serve as the internal technical authority for commercial small-molecule API manufacturing within a fully outsourced environment.
This role provides end-to-end technical oversight, governance, and lifecycle management of drug substance processes across a global network of CMOs. The position focuses on strategic technical decision-making, partner oversight, and ensuring consistent, compliant API supply–rather than hands-on manufacturing execution.
Key Responsibilities
Technical Authority & Governance
- Serve as the internal MSAT technical owner for commercial drug substance processes
- Maintain deep expertise in API synthetic routes, unit operations, impurity profiles, and control strategies
- Provide technical assessments and recommendations for decisions impacting product quality, process performance, and supply continuity
CMO Technical Oversight
- Act as the primary technical interface with CMOs for drug substance manufacturing
- Review, challenge, and approve CMO-led investigations, process changes, and optimization efforts
- Ensure alignment with approved processes and control strategies, with appropriate scientific justification for deviations
- Support critical manufacturing or quality events, including occasional off-hours engagement
Commercial Lifecycle Management
- Lead MSAT evaluation of post-approval changes, including:
- Site transfers
- Raw material changes
- Equipment updates
- Process modifications
- Ensure changes are scientifically robust, compliant, and aligned with regulatory commitments
- Drive process robustness and supply reliability through risk-based oversight
Deviation, OOS & CAPA Leadership
- Provide technical leadership for significant deviations, OOS events, and recurring trends
- Evaluate root cause analyses and corrective actions for effectiveness and completeness
- Ensure learnings are incorporated into ongoing process understanding and governance
Inspection Readiness & Regulatory Support
- Support global regulatory inspections by providing drug substance technical expertise and documentation
- Contribute to regulatory filings, responses, and variations related to commercial API manufacturing
- Ensure technical documentation and process knowledge are inspection-ready at all times
Cross-Functional Leadership
- Partner with Quality, Supply Chain, External Manufacturing, and Regulatory CMC teams
- Align on technical risk management, supply strategy, and lifecycle priorities
- Represent MSAT in governance forums and escalation discussions
- Influence stakeholders and external partners through technical expertise and sound judgment
Knowledge Management
- Ensure critical process knowledge is captured, maintained, and transferred across the external network
- Oversee technical knowledge transfer during CMO onboarding or site changes
Qualifications
Required
- Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field
(or Master’s degree with significant relevant experience) - 10+ years of experience in drug substance MSAT, technical operations, or process chemistry in a commercial environment
- Demonstrated experience working within outsourced or CMO-driven manufacturing models
- Strong knowledge of GMP requirements and global regulatory expectations for API manufacturing
- Proven ability to make risk-based technical decisions in complex environments
Preferred
- Experience supporting regulatory inspections at CMOs
- Track record managing post-approval changes within commercial portfolios
- Experience overseeing multiple CMOs or global manufacturing networks
Key Competencies
- Strong technical authority and scientific judgment
- Ability to lead and influence in a matrixed, virtual organization
- Structured, risk-based decision-making mindset
- Excellent written and verbal communication skills, including interactions with regulators and senior leadership
- Executive presence appropriate for Associate Director-level leadership
Why This Role
- Lead technical strategy and oversight for critical API manufacturing operations
- Operate in a highly visible role influencing quality, compliance, and supply continuity
- Work within a modern, outsourced manufacturing model with global impact
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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