Job Description

Job Title: Sr. Manager, Downstream Process Development
Work Location: Alachua, Florida
Division: Pharma Services Group-Viral Vector Services

When you are part of the team at Thermo Fisher Scientific, youll 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 youll be supported in achieving your career goals.

How will you make an impact?

In this role you will ensure that VVS provides its clients with robust, efficient processes that produce the highest quality viral vector therapies to meet our clients needs. You will direct and grow a team of approximately 20 personnel in downstream process development functions including process design and transfer, process optimization, process scale-up, planning, statistical and data analyses, adherence to PD standards with an understanding of cGMP standards, design of related documents (SOPs, precursors of batch records, etc.), supervising, hiring and training unit personnel and leading hands-on, in critical downstream development activities and effectively communication with clients. You will be responsible to prepare robust processes for viral vector purification and development of new technologies that support these novel therapeutics. You will work closely with technical transfer, process engineering, manufacturing units, quality assurance, quality control, MS&T, and business development teams to achieve client and company commitments. This includes support for operations and other process support teams providing scientifically and regulatory sound recommendations, improving efficiency, meeting timelines and developing successful processes.

What will you do?

* Oversee the design, optimization, scale-up and transfer robust viral vector purification processes
* Support Technical Program Leads and/or serve as TPL for specific client programs
* Design experiments to optimize and broaden the platforms used in the manufacturing processes performed at Viral Vector Services
* Lead/oversee investigations, risk assessments, FMEAs, and CAPA lifecycles to continuously improve viral vector purification platforms
* Provide on-the-floor leadership and scientific mentorship
* Provide technical leadership in developing new technologies for viral vector purification
* Define relevant operational/technical standards and practices for the site
* Identify and drive implementation of improvements to maximize throughput and capacity utilization
* Responsible for reviewing and vetting development plan designs and summary reports
* Building and leading a highly effective Downstream PD team to achieve department and division goals
* Work closely with all teams in Process Development. Quality Assurance, and Operations to transfer new processes into the GMP environment including, batch record development, material sourcing, media and buffer planning and identifying and configuring new equipment and process rooms, as needed.
* Supervise Managers and Lead Scientists
* Drive change management and inspire sub-teams growth and development
* Oversee Downstream PD operations and provide strategic and tactical leadership support

How Will You Get There?

Degree in Scientific or Engineering discipline required; PhD or Masters degree preferred

Experience

* Eight plus years experience in process development/technical operations role(s) in biopharmaceutical industry
* Experience with evaluation, design, and scale-up of downstream purification processes
* In-depth knowledge of viral vector purification equipment and processes (ultracentrifugation, chromatography, filtration, UF/DF)
* Experience in a customer-facing role is highly desired
* Demonstrated track record for managing a dynamic team in a complex, fast-paced environment
* Familiarity with ancillary business functions (finance, supply chain, GMP, quality) desired

Knowledge, Skills, Abilities

* Subject matter expert in manufacturing technologies and systems for the purification and formulation of viral vectors
* Familiar with viral vector production (upstream) and analytical techniques
* 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

* A high-level of understanding of the different small and large-scale development and cGMP equipment used for production of viral vectors (including ambr 15, bioreactors, filtration equipment, AKTA chromatography and Repligen TFF skids).
* Passion for driving innovation and collaboration in a complex, global environment
* Strong interpersonal skills and the ability to connect with and positively influence leadership and all levels of the organization
* Able to drive strategic thinking and proactive strategies in both engineering and operational areas.
* A holistic thinker who can look enterprise-wide to integrate and streamline technical solutions for optimal benefit across the business
* Excellent communicator, including solid written, oral and presentation-giving skills.
* High ethical standards to support a professional business code of conduct

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.