Role Summary

Reporting to the Director of Drug Substance (Biologics), MSAT, this role is an individual contributor position and will serve as a subject-matter expert (SME) in upstream and downstream processes for outsourced drug-substance manufacturing, technology transfer, life cycle management, and global regulatory submissions of complex Biologics, monoclonal antibodies, enzymes, bi-specifics, ADCs, and recombinant therapeutics.

The incumbent is responsible for overseeing all drug-substance manufacturing activities at the CMO site, including process scale-up, technology transfers, validations, PPQ campaign support, continuous process improvements, and post-approval lifecycle management of commercially approved products. The position also involves collaborating with various SMEs from MSAT, QA, QC, CMC, External Manufacturing, internal sites, and CMC Regulatory.

Primary Responsibilities

1. Technical Oversight & Manufacturing Support

• Serve as primary technical interface with global CMOs supporting Drug Substance manufacturing.
• Lead investigations for technical deviations, root cause analyses, and CAPA implementation.
• Supervise campaign readiness, change management, and process development discussions.
• Lead internal technical meetings and contribute to Virtual Plant Teams (VPTs) to manage timelines, supply impact, risks, and budget.

1. Technology Transfer, Scale-Up & Validation

• Oversee process scale-up, technology transfer, PPQ readiness, and validations across CMO sites
• Author and review validation protocols, reports, and technical documentation.
• Drive continuous improvement initiatives across upstream and downstream processes
• Drive standardization and knowledge-sharing practices across sites and the global network.

1. Lifecycle Management & CPV

• Own lifecycle management strategies for assigned commercial products across manufacturing sites.
• Establish and maintain robust process monitoring and Continuous Process Verification (CPV) strategies.
• Perform statistical analysis on campaign data to create and analyze process trends and control charts.

1. CMC & Regulatory Support

• Author and review CMC sections for global regulatory submissions (NDA, BLA, MAA, ND, IPMD)
• Support filing in new markets and impact assessment to post-approval changes.
• Support responses to health authority questions related to manufacturing processes and controls.
• Ensure manufacturing and validation strategies align with GMP, ICH, and global regulatory expectations.

1. Technical Leadership & SME Role

• Lead process risk and criticality assessments to identify gaps and define improvements.
• Support business development and technical due diligence activities as needed.
• Stay current with scientific literature, evolving technologies, and MSAT best practices.

Education and Required Skills

Academic Background:

• Ph.D. with 5 years of experience or M.S. with 8 years of experience preferred, B.S. with 10 years of experience required in Chemical Engineering, Biochemistry, Biotechnology, Synthetic Organic chemistry or Pharmaceutical Sciences.

Technical Expertise

• Extensive hands-on experience in upstream (microbial fermentation & mammalian cell culture) and chromatography, UF/DF, Viral clearance, Depth filtration techniques in protein purifications.
• Proven experience of working with Bioconjugation techniques, linker-payload development, HPAPIs for clinical/commercial ADC manufacturing is desirable.
• Experience in synthesis, purification, and characterization of antibody drug conjugates and enzymes is preferred
• Deep understanding of single-use technologies, microbiology, Extractables and Leachables (E&L) Scale-down models (SDMs), DoE, QbD, regulations, and process control strategy.

Regulatory and Compliance

• Proven track record in drafting and reviewing regulatory filings (MAA/NDA/BLA and Variations) and responding to Health Authority queries.
• Experience in authoring/reviewing dossier sections & reports. Strong understanding of cGMP & ICH guidelines

Data Analysis and Problem Solving

• Expertise in data management, statistical, and visualization tools such as JMP or Minitab.
• Advanced proficiency in problem-solving frameworks (e.g., Ishikawa, Kepner-Tregoe, 5-Whys).

Collaboration & Communication

• Proven experience collaborating with CMOs and external partners.
• Proficient in strategic planning and managing multiple complex projects simultaneously.
• Strong negotiation and influencing skills with the ability to work effectively in interdisciplinary teams.
• Excellent skills in drafting development reports, summaries, and technical presentations.
• Excellent verbal and written English skills, including active listening, attention to detail, and the ability to draft technical reports and presentations.
• Ability to thrive in dynamic environments that embrace change, risk, and flexibility.

Travel and Location

• Preferred location is in Boston, US but will consider remote applicants
• Domestic and international travel up to 20%

Job Description

Candidate Profile

Salary Range

The salary range for this role is $150,000 - $211,000. An employee's pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements). For more information on our benefits, please visit this link.