Associate Director, Small Molecule Drug Substance MSAT

SERVIER MONDE•Boston, KY

19h•$154,000 - $183,000•Remote

About The Position

As part of Servier’s global Manufacturing Science & Analytical Technology (MSAT) organization, the Associate Director serves as a subject matter expert in commercial small molecule drug substance manufacturing processes, with particular focus on ADC linkers and payloads. Reporting to the Head of Small Molecules Drug Substances within MSAT, the role provides technical support for assigned products manufactured at Servier sites and external contract manufacturing organizations. It supports process robustness, regulatory compliance, and performance monitoring through lifecycle management, technology transfers, production support, and continuous improvement. The position is full-time and remote, preferably based on the East Coast of the United States, with domestic and international travel up to 20%.

Requirements

Bachelor’s degree and 10 years of experience, Master’s degree and 8 years of experience, or PhD and 5 years of experience in Organic or Medicinal Chemistry.
Demonstrated proficiency in synthetic chemical process development and manufacturing support for small molecule drug substances, linker-payloads, and HPAPIs.
In-depth knowledge of complex multi-step organic synthesis, including highly potent compounds and isolation or purification technologies such as preparative HPLC.
Expertise in basic statistical methodologies and software such as Minitab, JMP, or equivalent.
Expertise with problem-solving tools such as Ishikawa, Kepner-Tregoe (KT), and five-whys.
Experience leading or supporting technology transfers, deviation investigations, change controls, and regulatory documentation in a GMP environment.
Strong knowledge of GMP, ICH, and EHS guidelines for HPAPI handling, including containment levels and occupational exposure limits (OEL).
Ability to work in a global matrixed team and collaborate across Quality, Manufacturing, Supply Chain, and Regulatory.
Strong organization skills and ability to manage multiple products simultaneously.
Excellent English communication and documentation skills, including effective interaction with internal stakeholders and external partners in an international environment.
Continuous-improvement and learning mindset aligned with the company’s strategic direction and patient-first values.

Nice To Haves

Experience in lifecycle management across late-stage clinical and commercial programs for linker-payload chemistry and the technical requirements for subsequent bioconjugation.

Responsibilities

Provide technical oversight of commercial small molecule drug substance processes at Servier sites and contract manufacturing organizations through Virtual Plant Teams.
Assess process robustness and control strategies, including parameters affecting reaction selectivity, impurity formation and purge, yield, crystallization, solid-state form, stability, and downstream conjugation performance.
Monitor emerging technical risks through continued process verification (CPV) and trend analysis; establish escalation criteria and recommend science- and risk-based actions.
Lead technical contributions to deviation and recurring-issue investigations, including root cause analysis, product-quality impact assessment, CAPA definition, and effectiveness confirmation.
Support safe and compliant manufacture of highly potent payloads through containment, cleaning, cross-contamination prevention, handling, and EHS risk assessments.
Capture and transfer process knowledge, including control-strategy rationale, process history, scale-up learning, investigation lessons, and manufacturing campaign experience.
Define technical transfer strategies for linker and payload processes, ensuring process knowledge, raw-material requirements, and safe-handling practices are understood at the receiving site.
Assess receiving-site fit and readiness, including equipment capability, materials of construction, containment, cleaning, reaction-safety controls, mixing, heat transfer, filtration, drying, and control of critical impurities and physical properties.
Identify and mitigate scale-up risks involving reaction kinetics, addition and quench profiles, mass and heat transfer, work-up, chromatography, crystallization, hold times, stability, and batch reproducibility.
Lead process-fit, risk-assessment, and FMEA activities and translate identified risks into actionable transfer plans with owners, acceptance criteria, and escalation paths.
Provide technical leadership for engineering and PPQ batches, assess unexpected results, determine comparability between sites, and close critical gaps before routine commercial manufacture.
Drive lifecycle improvements in process robustness, impurity control, yield, throughput, containment, sustainability, and supply reliability while maintaining product quality and regulatory commitments.
Author or review CMC sections of regulatory submissions, including post-approval changes, variations, and new-market filings as needed.
Support Regulatory CMC in responding to health-authority questions about commercial manufacturing processes and controls.
Ensure manufacturing and validation strategies align with GMP, ICH, and global regulatory expectations.
Stay current with industry trends, scientific literature, technologies, and MSAT best practices.
Support digital, sustainable, and patient-centered innovation in technical operations.