Director, Analytical Technology, MSAT Onc/Neuro Products jobs in United States
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Servier Pharmaceuticals · 19 hours ago

Director, Analytical Technology, MSAT Onc/Neuro Products

Servier Pharmaceuticals is a Boston-based biopharmaceutical company focused on advancing cutting-edge science in therapeutic areas. The Director of Analytical Technology will lead a team overseeing analytical methods for Oncology and Neurology drug products, ensuring compliance and driving innovation within the organization.

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H1B Sponsor Likelynote

Responsibilities

Lead the analytical strategy for Servier’s commercial small molecule Oncology and Neurology products, including project strategy, setting priorities, establishing team goals, and ensuring timely and high-quality deliverables for internal and external programs
Provide strategic leadership to SMEs supporting internal, external manufacturing sites and site-based MSAT analytical teams, as applicable, to develop, validate, and transfer analytical methods for drug substances and drug products in support of commercial supply
Collaborate with MSAT Business Operations and Portfolio team to ensure appropriate prioritization and resource allocation to ensure successful delivery of SOT objectives across internal and external sites as applicable
Collaborate closely with CMC counterparts, who lead development-stage activities for pipeline assets, and ensure effective technical transition from CMC SMEs to MSAT as part of new product commercialization
Contribute to the preparation of global regulatory submissions, including new and post-approval changes, with clear and accurate source documentation, control strategy, and justification of specifications, comparability studies, and stability studies according to subject matter understanding and regulatory guidelines
Build and maintain strong collaborations across the organization, including key stakeholders in Global Manufacturing, CMC, Regulatory and Quality teams, peers, and senior management
Systematically identify gaps and risks across analytical methods and implement appropriate mitigations/improvements that ensure robust analytical testing across product lifecycle and facilitate uninterrupted commercial supplies
Support internal and external audits, inspections, pre-approval activities, and maintain a state of continuous readiness across the product portfolio
Evaluate new technologies and sites as needed
Support Due Diligence of external opportunities as needed
Stay current with industry trends, scientific literature, and evolving technologies related to OSD analytics and MSAT best practices

Qualification

Analytical Chemistry Ph.D.Solid Dosage AnalysisMethod DevelopmentRegulatory SubmissionsAnalytical Control StrategyRelationship ManagementStatistical SoftwareCoaching SkillsEnglish CommunicationGrowth MindsetOrganizational SkillsTeam Collaboration

Required

Ph.D. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related field with a minimum of 7 years of experience in the pharmaceutical industry or M.S. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences with a minimum of 10 years of experience in the pharmaceutical industry preferred. B.S. in Chemistry or a related field with a minimum of 12 years of experience in the pharmaceutical industry required
Demonstrated ability to coach and develop direct reports
Consistently demonstrating growth mindset, adapting to and championing change, with a passion for building capabilities, to help shape the future of MSAT within a transforming organization
Experience in relationship management of Contract Research Organizations and contract laboratories
Extensive experience in the analysis of solid dosage forms, including HPLC, GC, KF, IC, LC-MS, UV-Vis, XRPD, DSC, FT-IR, SEM, optical microscopy, and microbial analysis
Proficient in solid-state analysis, physical characterization, and drug product dissolution
Experience in method development, validation, and routine analysis for Nitrosamine impurities in drug product test samples
Strong background in analytical control strategy development and execution
Previous experience in drafting and reviewing analytical sections of regulatory submissions, including new submissions (e.g., NDA/MAA) and post-approval Variations, as well as responding to health authority queries
Strong strategic thinking capabilities with a forward-looking perspective and demonstrated learning agility with a drive to solve problems
Excellent organizational, program management, and planning skills; adaptive learning, critical thinking, and the ability to work well in a team environment
Ability to work in a team-oriented environment that embraces change, risk, and flexibility
Excellent English communication skills – written and verbal, with strong presentation skills to create and deliver summaries and reports as needed
High proficiency in Word, Excel, PowerPoint, SmartSheet and statistical software (JMP, Prism)

Preferred

M.S. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences with a minimum of 10 years of experience in the pharmaceutical industry
Hybrid (2-3 days in our Boston office) preferred. Open to remote candidates

Benefits

Short-Term and Long-Term incentive programs
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

Company

Servier Pharmaceuticals

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Servier Pharmaceuticals is a pharmaceutical company dedicated to therapeutic progress to serve patient needs.

H1B Sponsorship

Servier Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (4)
2023 (4)
2022 (3)
2021 (15)
2020 (2)

Funding

Current Stage
Growth Stage

Leadership Team

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David K. Lee
Chief Executive Officer
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Pedro Crisanto
Chief Operating Officer R&D, USA
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Company data provided by crunchbase