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.
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
The Technical Project Lead in the Manufacturing Science & Technology group will report into the Technical Project Lead Manager. This position is located in Cambridge, MA supporting the Viral Vector Service group.
How will you make an impact?
The Technical Project Lead is responsible to ensure that all technical aspects of a project are managed either directly or in collaboration with the Project team, ensuring that products/processes are compliant with company and regulatory quality standards.
What will you do?
- Be the primary technical interface with clients
- Perform technical review for internal and client project documents (tech transfer documents, development/process characterization/process validation plans, production/test records, summary reports).
- Attend and/or lead internal and client project meetings
- Provide leadership on technical strategy and execution from project initiation through scale up and tech transfer.
- Provide technical assessment on project change controls and deviations
- Perform equivalency assessments/gap analyses during tech transfer activities and sourcing/designing materials or equipment as needed
- Work closely with the client and personnel from Manufacturing, Process Development, Process Sciences, Quality Control, Quality Assurance, Operations, and Project Management to ensure the scientific and CMC strategies are robust and maintained.
How will you get here?
- B.S in the life sciences, engineering, or equivalent technical field and 8+ years of experience, or MS and 6+ years of relevant experience or a PhD and 4+ years of relevant experience.
- Demonstrated manufacturing technical support experience in a Viral Vector, Biologics, or vaccine production
- A sound understanding of viral vector production and analytics, scale-up principles, process validation, and regulatory strategies.
- Experience in research & development or manufacturing a plus.
Knowledge, Skills, Abilities
- Ability to lead teams and manage others
- Proficient in Microsoft Office program suite
- Strong documentation practices, organizational skills, and attention to detail
- Strong verbal and written communication skills
- Excellent interpersonal skills
- Ability to work collaboratively and independently
- Strong decision-making and problem solving skills
- Ability to elicit cooperation from a wide variety of sources, including many departments within the company and work as a team player
- Ability to effectively prioritize and execute tasks in a dynamic environment
- Experience with Statistical and data analysis a plus
- Familiarity with following software packages a plus: Visio, JMP, and MS Project
- Familiarity with project management knowledge and skills a plus
- Knowledge of FDA, EMA, and other relevant regulatory environments is a plus.
At Thermo Fisher Scientific, each one of our 70,000 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.
To Apply, please click the following link: https://thermofisher.contacthr.com/73777439
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