MSAT Analytical Specialist, DS and DP Synthetic
Sanofi
August 24, 2026
On-site
Cambridge, MA
$148,500 - $214,500 USD yearly
Operations
Responsibilities:
- Serve as Analytical SME supporting the MSAT Synthetics platform with comprehensive CMC analytical support for new product introductions, lifecycle development, and manufacturing assistance.
- Coordinate analytical studies and programs across internal MSAT centers and CDMOs; support analytical control strategy.
- Support analytical technology transfers, method development/optimization, and commercial product analytical support.
- Plan and execute analytical study protocols; analyze data and perform stability trending.
- Support regulatory dossier development and responses to registration questions.
- Participate in MSAT Technical Product Team (TPT) and CMC/CMC project teams; collaborate with MSAT/R&D, External Manufacturing, Regulatory, Quality, and third-party manufacturing sites.
- Review documentation, initiate studies, follow up, review/summarize data, and write reports; conduct lab investigations/troubleshooting.
- Prepare analytical testing protocols and budget plans; support development plans, analytical upgrades, and manufacturing technical transfers (including stability studies) in compliance with ICH/FDA guidelines.
- Attend CRO/CMO planning/progress meetings and analytical testing evaluations.
Qualifications:
- MS/degree in Pharmaceutical Sciences, Life Sciences, Chemistry, or related field.
- 7+ years in Regulatory CMC, Process/Pharmaceutical Manufacturing Development, Analytical Science, or related.
- Confirmed project management experience in complex, cross-site environments; understanding of cGMP and regulatory/scientific trends; experience leading international/multi-cultural teams.
Skills (required/preferred):
- HPLC (experienced/advanced), Dissolution Testing (experienced/advanced), Mass Spectrometry (intermediate/experienced).
- Method development/validation, analytical testing, GMP compliance, risk management, standards compliance, project management, strategy development, stakeholder communications, technology transfer.
- Cross-functional teamwork and collaborative communications.
Benefits/Instructions:
- Regular travel to internal and contract sites required.
- Serve as Analytical SME supporting the MSAT Synthetics platform with comprehensive CMC analytical support for new product introductions, lifecycle development, and manufacturing assistance.
- Coordinate analytical studies and programs across internal MSAT centers and CDMOs; support analytical control strategy.
- Support analytical technology transfers, method development/optimization, and commercial product analytical support.
- Plan and execute analytical study protocols; analyze data and perform stability trending.
- Support regulatory dossier development and responses to registration questions.
- Participate in MSAT Technical Product Team (TPT) and CMC/CMC project teams; collaborate with MSAT/R&D, External Manufacturing, Regulatory, Quality, and third-party manufacturing sites.
- Review documentation, initiate studies, follow up, review/summarize data, and write reports; conduct lab investigations/troubleshooting.
- Prepare analytical testing protocols and budget plans; support development plans, analytical upgrades, and manufacturing technical transfers (including stability studies) in compliance with ICH/FDA guidelines.
- Attend CRO/CMO planning/progress meetings and analytical testing evaluations.
Qualifications:
- MS/degree in Pharmaceutical Sciences, Life Sciences, Chemistry, or related field.
- 7+ years in Regulatory CMC, Process/Pharmaceutical Manufacturing Development, Analytical Science, or related.
- Confirmed project management experience in complex, cross-site environments; understanding of cGMP and regulatory/scientific trends; experience leading international/multi-cultural teams.
Skills (required/preferred):
- HPLC (experienced/advanced), Dissolution Testing (experienced/advanced), Mass Spectrometry (intermediate/experienced).
- Method development/validation, analytical testing, GMP compliance, risk management, standards compliance, project management, strategy development, stakeholder communications, technology transfer.
- Cross-functional teamwork and collaborative communications.
Benefits/Instructions:
- Regular travel to internal and contract sites required.