Vacancy expired!
Job Title: MSAT Staff Scientist/EngineerLocation: Carlsbad, CAWhen 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 InformationAt Microbial Manufacturing Services (MMS), a new Business Unit within Thermo Fisher Scientific’s Pharma Services Group, we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice.How will you make an impact?In this role, you will be part of the Manufacturing Sciences and Technology department, responsible for supporting all facets of the Tech Transfer, Process Establishment, and GMP Floor Support for our Carlsbad, CA operation in accordance with current good manufacturing practices (cGMP). You will provide strong technical oversight to the process sciences and manufacturing departments to ensure robust and reliable production processes are established.What will you do?Work with Project Manager to Lead Technology Transfer from Process Development and/or Client to commercial Manufacturing ensuring effective information flow, timeline execution, issue resolution, and documentation in accordance with governing tech transfer quality system requirements while leveraging robust risk management practices.
Support late stage clinical and commercial stage products including overseeing the design and execution of studies, investigation, and data analysis of results.
Provide technical leadership to process engineers, scientists, and associates for process validation and commercial stage products including defining and overseeing the design and execution of studies.
Work closely with the clients and internal Manufacturing, Process Development, Process Sciences, Quality Control, Quality Assurance, Operations, and Project Management to ensure best practices are followed and CMC strategy implemented.
Perform detailed technical review of internal and external project documents (e.g., tech transfer documents, development/process characterization, process validation plans, production/test records, summary reports).
Write and/or review of technical reports and/or any source documentation and reports required for CMC sections of US and international clinical trial applications.
Help to define and implement the MS&T procedures, systems, and practices for new product introduction, process validation, and continuous process verification in accordance with cGMP and ICH guidelines.
Provide technical and scientific support any manufacturing process related events such as manufacturing deviations, technical troubleshooting, change control and optimizations.
Provide on-floor technical support for manufacturing processing, PIP (Person in Plant).
How will you get here?B.S in the life sciences, engineering, or equivalent technical field required
6+ years of related experience, or MS and 4+ years of relevant experience or a PhD and 2+ years of relevant experience, preferred
Demonstrated manufacturing technical support experience in a Microbial, Viral Vector, Biologics, or vaccine production
A sound understanding of pDNA production and analytics, scale-up principles, process validation, and regulatory strategies.
Preferred ExperienceHands on experience in PD, GMP MFG, or Manufacturing Sciences in microbial or mammalian biologics manufacturing for Biopharma or other highly regulated environment
Experience with cell culture-based manufacturing, tech transfer, investigations, and process validation of commercial-scale human therapeutics; ideally, with single-use technology systems
Experience working in or with a CDMO
Knowledge of plasmid / microbial manufacturing processes and Single Use equipment
Understanding and/or knowledge of change control and performing process impact assessments.
Knowledge, Skills, AbilitiesUnderstand microbial production processes and the production environment
Good understanding of cGMP and other regulatory requirements
Analytical problem-solving skills
Make good business decisions using both cost and risk analysis
Strong communication and presentation skills (verbal and written in English)
Handle multiple tasks, issues, projects
Work independently and as a part of a team
Build agreement via collaboration
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Vacancy expired!