Job Description

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.

The Viral Vector Services (VVS) business unit is a key component to our growth trajectory within Thermo Fisher Scientific's Pharma Services Group focused on contract development and manufacturing services. At Viral Vector Services (VVS), we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

How will you make an impact?

As the Director of Process Engineering and Process Analytical Technology, you will join the global bioprocess development leadership within VVS and build process engineering and scale-up expertise to support Turnkey and other customer platforms. The candidate will provide technical leadership over design of experiments, drive innovations, and on-board new process analytical technologies to continuously advance process characterization and scale up at VVS. The candidate will work closely with Global Engineering, Global IT, MSAT, Global Process Sciences and Analytical groups to drive technology roadmap and implementation of key PAT initiatives.

Key Responsibilities

* 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. Use CFD and data modeling to reduce tech transfer timeline.

* Work closely with IT and Global engineering to develop data collection and management strategy for process sciences and pilot labs. Utilize data to develop scale-up models and continually improve right first-time metrics.

* Build and develop a high-performing PAT and engineering team ensuring the right skills are added at the appropriate time during periods of rapid growth.

* Provide technical leadership to resolve complex investigations and use advanced data analytics to reduce scale up and PPQ risks.

* 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 analytics implementation.

* Serves as technical SME in clients2019 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 here?

Education

* Master's Degree or PhD in a life science or chemical engineering discipline

Experience

* A minimum of 10+ years hands-on experience in developing and scaling up manufacturing processes for vaccines and/or biologics, preferably with cell therapy and/or gene therapy product experience.

* Experience in data management strategies, process modelling leading to successful PPQs, preferably in a proven biopharma organization.

* 7+ 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 mammalian cell culture-based manufacturing, tech transfer, investigations, process characterization, and process validation of commercial-scale human therapeutics

Knowledge, Skills, Abilities

* Expertise and Knowledge of cell culture-based manufacturing, tech transfer, PAT implementation, and scale-up of commercial-scale human therapeutics. Preferably experience in AAV, LV process development.

* 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, CFD modeling, 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.

Physical Demands

* Ability to function in a rapidly changing environment & handle multiple priorities.

* Ability to lift up to 25 lbs.