Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Cambridge, MA / VVS
How will you make an impact?
As the Senior Manager of the Process Engineering and Scale-up, you will lead process engineers to drive bioprocess development and robust process scale-up of viral vector manufacturing processes. You will provide technical leadership over design of experiments, drive innovations, and on-board new technologies to continuously advance process characterization and scale up methodology at VVS. The candidate will also develop and manage budgets, resources, and align with Manufacturing Sciences and Technology, PMO, Commercial Ops, Engineering and Manufacturing organizations to deliver on project milestones.
What will you do?
- Candidate will provide subject matter expertise in upstream and downstream process development, characterization, and scale-up leading to successful commercialization of various gene therapy products.
- Candidate will continually assess and on-board new technologies to enable VVS deliver gene therapy products (AAV and LV) in a faster and reliable manner to the clients and the patients.
- Plan, generate and execute protocols for DOE studies that include appropriate statistical analysis and generate and present reports.
- Plan and perform metabolite/spent medium analyses, medium development and cell line and transfection development studies.
- Build and develop a high-performing process science and engineering team ensuring the right skills are added at the appropriate time during periods of rapid growth.
- Provide technical leadership of technically complex investigations and use advanced data analytics and study design to recommend continuous process improvements that enable successful PPQs.
- Lead development of dashboards to track and trend the metrics. Report metrics to technical teams and upper management. Facilitate root cause analysis and ideation of the improvement opportunities from the metric discussions.
- Foster an inclusive, collaborative, transparent, engaged and accountable culture. Coach team for positive inter-departmental collaboration
- Proactively develop and sustain strong relationships with clients and services suppliers. Partner with internal stakeholders and cross-functional / cross site teams to facilitate successful customer management.
- Responsible for establishing the budget and CAPEX for process sciences department.
- Serves as technical SME in clients’ meeting, regulatory audit, and key conferences; supports proposal development for existing and prospective clients in conjunction with sales and business development.
How will you get there?
- Master's Degree or PhD in a life science or chemical engineering discipline with extensive experience in scale up and characterization of biologics. Strong background in viral vectors is plus.
- A minimum of 7+ years hands-on experience in developing and scaling up manufacturing processes for bacterial and mammalian cell and virus/viral vector-based processes, including cell banking, adherent and suspension cell cultures in batch, fed-batch, and perfusion modes.
- Experience in commercializing a biologic product; designing and executing pre-PPQ activities to support MST, preferably in a proven biopharma organization.
- 5+ years in a PD, PS and/or MS&T or highly technical leadership role with proven record of strong leadership
- Solid foundation in the knowledge of cGMP and biochemical engineering.
- Strong experience in tech transfer, investigations, process characterization, and process validation of commercial-scale viral vector processes.
Knowledge, Skills, Abilities
- Expertise and knowledge of cell culture-based manufacturing, tech transfer, investigations, and scale-up. Preferably experienced in AAV, LV process development and scale-up.
- Assemble, operate, and troubleshoot single-use stirred tank bioreactors from bench scale to 200L working volume scale.
- Ability to analyze, interpret and compile data, define problems, establish facts, draw valid conclusions and make decisions.
- Ability to deal with abstract and concrete variables in situations with limited standardization.
- Ability to influence actions and drive results within a matrix environment.
- Ability to lead teams in a high paced, dynamic environment while maintaining order and big-picture perspective.
- Ability to interact and communicate with internal and external senior management and explain a topic in the appropriate context for full understanding.
- Solid knowledge and understanding of current cells and gene therapy applications, challenges, and strong desire and expertise in developing new innovative technologies to address those challenges.
- Strong track record of translating new product ideas into project plans and executing them by assigning resources as well as tracking project progress toward milestones and deadlines.
- Understanding of guidelines required by FDA, EMA, and other regulatory bodies
- Excellent troubleshooting skills and ability to solve complex technical issues
- Excellent oral and written communication / presentation skills in small and large group settings.
- You must have expertise in statistical design of experiments and data analysis
- You should have a thorough understanding of guidelines required by FDA, EMA, and other regulatory bodies for commercialization of biologics therapies
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
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.