Genzyme Corporation
MSAT Analytical Specialist, DS and DP Synthetic
Cambridge, MA
Sponsorship not specified$50k-$215kDetected 12 days ago
Data AnalysisProject ManagementStrategic CommunicationsGMPFDA RegulatoryMass SpectrometryCommunication
About the role
- The position involves coordinating analytical studies and programs at both internal MSAT centers and CDMOs.
- The role also encompasses planning and executing analytical study protocols, conducting data analysis and stability trending as well as supporting regulatory dossier development and responses to registration questions.
- With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Requirements
- Masters Degree in Pharmaceutical Sciences, Life Sciences, Chemistry or other related fields.
- 7+ years of experience Regulatory CMC, Process / Pharmaceutical Manufacturing Development, Analytical Science, or other related fields
- Confirmed experience in project management, in working in project team and in complex environment (e.g., transversal assignments across different sites).
- Experience and understanding of current pharmaceutical environment trends including scientific and regulatory challenges.
- Strong understanding and previous experience and training on cGMP requirements.
- Experience and understanding of current pharmaceutical environment including the economic and regulatory challenges.
- Experience in leading international and/or multi-cultural teams.
- Regular travel to internal and contract sites is required.
- Visits to internal M&S sites, development centers and contract labs and CMOs are required.
- This includes review and input for analytical method development, analytical method validation, associated reports and required stability studies, including trending analysis, in compliance with ICH/ FDA guidelines.
Skills
- High-Performance Liquid Chromatography (HPLC) (Experienced/Advanced)
- Dissolution Testing (Experienced/Advanced)
- Mass Spectrometry (MS) (Intermediate/Experienced)
- Manufacturing Process Improvements (Experienced/Advanced)
- Integrated Planning (Experienced/Advanced)
- Functional Skills:
- Method Development (Experienced/Advanced)
- Analytical Testing (Experienced/Advanced)
- Method Validation (Experienced/Advanced)
- GMP Compliance (Experienced/Advanced)
- Risk Management (Experienced/Advanced)
- Standards Compliance (Experienced/Advanced)
Compensation
- All compensation will be determined commensurate with demonstrated experience.
Benefits
- Employees may be eligible to participate in Company employee benefit programs.
- Additional benefits information can be found through the LINK.
Visa & Work Authorization
- ual opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity
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