Sr Manufacturing Technical Specialist
About The Position
Senior MSAT Purification Specialist provides scientific and technical support to drug substance manufacturing / production operations to ensure efficient and safe drug substance manufacturing processes at Vacaville. Works in collaboration with Manufacturing, Process Development, Quality, and other technical and business functions by specifying process requirements, driving for process optimization, maintaining the validated state of manufacturing process, and introducing new processes and new technologies in accordance with current Good Manufacturing Practices (cGMP) requirements and corporate standards. Lead complex projects, act as a lead Vacaville MSAT representative to other site and network teams, coach other team members as well as, when assigned, oversee, review and approve the work of other team members.
Requirements
- Bachelor’s degree in life sciences/engineering required, advanced degree in life sciences/engineering preferred.
- 10 or more years of experience (including advanced degree) in pharmaceutical industry specializing in purification of drug substance protein therapeutic; including experience across various disciplines in local or global roles.
- Experienced with technology transfers, process validation, authoring regulatory submissions, Health Authority interactions, inspections, and resolution of product/process quality investigations.
- Expert in purification and separation sciences of drug substance protein therapeutic.
- Strong knowledge of cGMPs, Health Authority regulations, and Quality Systems.
Nice To Haves
- Knowledge of the following software is desirable: OSI PI (and associated client tools), R,SAS JMP, SQL, Tableau.
Responsibilities
- Technical lead/SME providing scientific expertise and driving complex purification process decisions across projects.
- Partner with site and network stakeholders to ensure effective technical knowledge transfer and long-term commercial product support.
- Drive technical decisions by balancing business, product, quality, and manufacturing operational needs.
- Maintain cGMP compliance and ensure purification process specifications meet regulatory and business requirements.
- Lead process optimization, troubleshooting, and new process evaluations through laboratory studies and data-driven analysis.
- Support regulatory submissions, inspections, change management, and resolution of significant manufacturing or quality issues.
- Mentor junior team members and drive continuous process improvement, process monitoring, and product/process health management.
Benefits
- Performance-related bonus
- Medical, dental and vision insurance
- 401(k) matching plan
- Life insurance, as well as short-term and long-term disability insurance
- Employee assistance programs
- Paid Time Off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
