Technical Product Lead

Company: Thermo Fisher Scientific
Location: Needham
Posted on: April 10, 2021

Job Description:

Technical Product Lead, ManagerSciences & Technology, MMSWhen you are part of the team at Thermo Fisher Scientific, you will 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 will be supported in achieving your career goals.Location/Division Specific InformationAt Microbial Material 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?The Technical Product Lead will report to the Global Head of Manufacturing Sciences and Technology (MS) and will be responsible for leading Tech Transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing practices (cGMP) for MMS clinical, commercial manufacturing facilities. This role will partner closely with Operations and Quality Leadership. Specifically, they will provide strong technical and scientific support to process development teams and manufacturing teams at Carlsbad, CA site. They will also be involved in the supervision and support of MMS' contract manufacturing site in Watertown, MA to ensure establishment of robust and reliable production processes. Typical MMS manufacturing processes include high density fermentation, harvest, extraction, depth filtration, liquid chromatography steps and ultrafiltration steps.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 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).This role may require up to 30% Travel.How will you get here?MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Microbiology, Chemistry, or related Life Sciences/Engineering field'8+ years of BioPharmaceutical or Biotechnology industry experience working on GMP biologics upstream and downstream manufacturing processes.Demonstrated experience leading projects relating to Technology Transfer and Process Validation,Strong experience working cross functionally leading activities with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments.Ability to interface and communicate extensively with internal and external clients, including senior management.Must have extensive experience working in a dynamic and complexed manufacturing unit in a highly regulated environment.A sound understanding of biologics production and analytics, scale-up principles, process validation, and regulatory strategies.Strong Scientific and Engineering technical experience performing downstream protein purification manufacturing.Knowledge, Skills, AbilitiesGood understanding of cGMP and other regulatory requirementsUnderstanding of guidelines required by FDA, EMA, and other regulatory bodies.Analytical problem-solving skills. Ability to analyze, interpret and compile data, define problems, establish facts, draw valid conclusions, and make decisions.Good communication and presentation skills (verbal and written in English). Ability to interact and communicate with internal and external senior management and explain a topic in the appropriate context for full understanding.Unquestionable integrityLead change. Ability to influence actions and drive results within a matrix environment.Handle multiple tasks, issues, projects.Work independently and as a part of a team.Build agreement via collaboration.Ideally has CDMO experience.Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Keywords: Thermo Fisher Scientific, Boston , Technical Product Lead, IT / Software / Systems , Needham, Massachusetts