MST Scientist III, Downstream
Posted on Feb 14, 2020 by Thermo Fisher Scientific
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.
The MST Scientist III, Downstream will manage planning, execution, and internal/external customer interactions for continuously improving the manufacturing operations process at the plant/site. S(he) will support manufacturing team on the manufacturing floor to produce product, troubleshoot process events, help drive process improvements, error proof the process, investigate deviations, and provide ownership for specific client programs. S(he) will work closely with colleagues in the ENG, PD, Quality, EHS, Commercial, and Manufacturing to ensure compliance and successful technology transfers. This position will interface directly with external clients to provide scientific expertise and process guidance.
What will you do?
- Lead or be a member of cross functional technology transfer teams for cGMP cell banking/DS/DP manufacturing of viral vectors. Collaborate with other sites or clients to ensure success of scale up/process transfer. Ensure effective information flow, risk assessment, timeline execution, issue resolution and documentation for cross-functional teams. Includes leading the tech transfer facility fit gap assessment.
- MST process lead on client programs as assigned, ensuring the materials, strategy and documentation are in place.
- Work with external partners to support development, qualification, supply, and cGMP manufacture/packaging/labeling.
- Author or provide technical review of batch records for development/tech transfer and related cGMP documentation (eg, raw material specifications, equipment specifications, validation, supportive development protocols/reports, applicable sections of CMC regulatory filings, etc.).
- Author or assist in preparing PPQ protocols and reports. Assist in providing man in plant' oversight to development and qualification related activities (eg. oversee execution of development, GMP and PPQ related activities).
- Collaborate with PS/PD/QC/QA to develop testing strategy for raw materials, start materials, intermediates, DS and DP.
- Develop sampling plans with clients and incorporate them into cGMP batch documentation.
- Maintain database containing pedigree of all GMP manufacturing and development activities (ie, raw material lot #'s, assay, yield, deviations, and other critical attributes).
- Maintain critical quality attribute, in-process and release data tracking and trending analysis as well as in-process equipment parameter tracking and trending analyses.
- Support engineering teams on equipment selection, qualification, and start up activities.
- Investigate root causes of major deviations for cGMP manufacturing, and implement CAPA for major deviations. Work with counterparts in VVS's Alachua Process Development and Cambridge Process Sciences, Manufacturing, Quality, Project Management teams etc. to facilitate technology transfer and project success.
How will you get here?
- Bachelor or advanced degree in Biochemical, Chemical Engineering, pharmaceutical science or a related scientific discipline such as Chemistry or Biology.
- B.S. with 5+ years' experience, or Master's degree with 6+ years' academic/pharmaceutical/biotech industry experience, or PhD with 3+ years' academic/pharmaceutical/biotech industry experience.
Knowledge, Skills, Abilities
- Strong interpersonal and communications skills; written and oral. Ability to speak effectively before clients.
- Ability to work both independently and as part of a team.
- Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects
- Expertise in late stage/commercial technology transfer and process validation biopharmaceutical/gene transfer vector manufacturing preferred.
- Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
- Knowledge of cell and gene therapy vector production highly desirable.
- Project management skills desirable.
- Ability to be hands-on
- Ability to speak effectively before groups of customers.
- Ability to prepare/control project documentation; schedule/track project progress; work within defined project scope & budget.
- Works collaboratively in a cross-functional team environment and wins support from coworkers; Ability to plan and supervise the development of technical deliverables.
- Experience with drug product formulation, disposable and single-use technologies, sterile filtration, mixing strategies, fluid transfer to and from various compounding vessels/biobags, QC sampling requirements.
- Current in cGMPs and how to implement process designs and systems that promote cGMP compliance
- Knowledge of pharmaceutical manufacturing of sterile products, aseptic processing, and drug/device combination product manufacturing (including formulation, mixing, filtration, fill finish).
- Experience with automated fill finish line and controlled isolator environment considerations. Knowledge of formulation and storage conditions. Utilizes manufacturing processes knowledge and investigational skills to identify and resolve manufacturing issues and drives continuous improvement in process operations.
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.
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