Senior Scientist/Principal Scientist, Oligonucleotides
Framingham, Massachusetts, Frankfurt am Main, Germany
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Senior/Principal Scientist will be part of the oligonucleotides subject matter expert team and is responsible for providing technical and program management leadership by performing the following duties:
Leads LCM programs by representing MSAT in global Industrial Affairs (IA) cross-function and cross-site product teams.
Provides vital technical insight to global MSAT programs including process and analytical development, process control strategy, continuous process verification, manufacturing support and improvement, global tech transfer and validation. Leads LCM activities in MSAT project teams.
Provides scientific guidance to MSAT Lab operations regarding the design, set-up, and execution of scale-down experiments. Participates in Lab results analysis and bridging between the experimental outputs and manufacturing practice
Participates in monitoring the health of manufacturing process capability across the product portfolio manufactured in internal/partner Industrial network to identify common trends or major risks in their expert domain and recommends preventative or remedial actions to Manufacturing, Molecular Stewards or Site teams as appropriate for implementation
Works with cross-functional teams to resolve deviations, align global control strategies (raw materials, process, methods, equipment), and mitigate potential risks.
Support QC and regulatory teams during health authority audits and prepare for supportive regulatory documents for responses or new filings. May lead internal documentation and preparation of reports required for regulatory documents
Provides technical mentorship and training to Lab operation team and manufacturing team as needed
- Degree in chemistry, chemical engineering or other relevant discipline
- BS with 10+ years of professional experience
- MS with 7+ years of professional experience
- PhD with 5+ years of professional experience
- Minimum of 4 years of hands-on experience in oligonucleotide synthesis and/or commercial manufacturing operations
- Process development experience with synthesis of oligonucleotides and small molecules
- Knowledge across technical domain (synthesis, process HPLC, formulation, lyophilization)
- Prior experience with leading projects and mentoring technical staff
- Excellent verbal and written communication skills
- Highly motivated individual with the ability to work independently as well as on a cross-functional and cross-site teams
SPECIAL WORKING CONDITIONS:
Domestic and International travel required
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