Location/Division Specific Information
Thermo Fisher Scientific - Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.
This role is based in the Greater Boston Area – Seated remotely in the interim, ultimately seated in new commercial facility in Plainville, MA. Occasional travel to Alachua, FL and other local facilities may be required.
How will you make an impact?
The Senior Manager, Process Engineering is responsible for leading a team of engineers and contractors supporting equipment and clean utilities used in drug substance and drug product manufacturing, quality control laboratories, and associated support areas at VVS’ newest commercial facility in Plainville, MA. The initial focus of the position is supporting the new facility operationalization, equipment procurement, and establishment of the site engineering programs, and will later transition into an operations role. In operations, the Sr. Manager is responsible for the engineering support of clinical and commercial manufacturing of gene therapy products.
What will you do?
- Lead a team of process engineers engaged in tech transfers of new products into the manufacturing facility and provide continued support throughout manufacturing campaigns.
- Oversee equipment specification of manufacturing and analytical equipment and identifies opportunities to improve robustness, reliability, and other aspects of operational performance.
- Work with the site Facilities & Engineering Leadership and the Global Engineering team to plan and manage operational budgets and capital investments.
- Lead responses to process & equipment related issues during production
- Create and maintain relationships with other VVS sites to develop and promote engineering best practices and ensures compliance with VVS SOP’s, safe work practices, and cGMP regulations. The position involves close collaboration with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities.
How will you get here?
- Bachelor’s degree in engineering, science, or related field, with evidence of operational, leadership, or professional experience.
- Ten years’ experience in process development, operations or engineering in the biologics manufacturing industry
- Experience with people and project management
- Experience with biologics drug substance and/or drug product manufacturing
- Experience with single-use technologies strongly desired
- Experience with drug product filling and isolator technologies
- Experience with VHP sanitization desired
Knowledge, Skills, Abilities
- In depth understanding of general cGMP standards and practices
- Strong knowledge of process equipment and unit operations (Bioreactors, Chromatography, TFF, Autoclaves, media/buffer preparation, etc.) and associated process utility systems
- Candidate must have the capability to define and set technical direction for process unit operations
- Candidate must also have the capability to define user requirements in support of designing or procuring manufacturing equipment
- Strong understanding of applicable regulatory requirements. Audit experience is preferred.
- Strong technical documentation review and revision experience
- Strong interpersonal and communications skills; written and oral
- Ability to set goals and direction for others
- Comfortable supporting concurrent issues
- Working with both hands-on and remote based staff
- High ethical standards to support a professional business code of conduct.
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
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