Senior Associate Scientist

ROLE SUMMARY

The selected candidate will join the Rare Disease Research Unit where we are building industry leading capabilities in process development and research-grade manufacture of gene therapy therapeutics in Morrisville, NC. This position is responsible for taking an active role in manufacturing of research grade vectors in the Rare Disease Research Unit. The Scientist will be part of a multi-disciplinary team which is responsible for the transfer and execution of operations of virus production and purification, resulting in the production of research-grade vector in support of Pfizer's Rare Disease portfolio. Additionally, responsibilities will include generation of process batch records, acquisition of raw materials, and the purchase, installation, and startup of new capital equipment. The incumbent will also be responsible for the mining and evaluation of process data, modeling, and the generation of reports to support manufacturing scale-up. Training of development personnel for safe and effective operations and process safety assessment are also crucial.

Qualified candidates will have experience in gene therapy, biological, and/or vaccine process development, technology transfer, and scale up. The candidate must demonstrate the technical acumen and interpersonal skills to seamlessly interface across functional boundaries - including but not limited to process development, manufacturing, analytical R&D, and quality operations. The qualified candidate will deliver results in a team-oriented and start-up like setting and be responsible for applying bioprocess knowledge to ensure successful manufacturing of gene therapy medicines.

ROLE RESPONSIBILITIES

Responsibilities include:

- Lead meetings that involve the 50L and 250L SUB process

- Identify, communicate, track, and hold team members accountable for project deliverables.

- Evaluate lab-scale processes and define the scaled up process for the RDRU Vector manufacturing team.

- Interface with development scientists and propose options to resolve process fitting issues.

- Capture knowledge through review of documentation, observation of batches, compiling process descriptions and flow diagrams, interacting and training site personnel.

- Capture all aspects of the existing process and equipment at the donor sites to ensure that an equivalent process is started up in RDRU manufacturing

- Provide raw material forecasts for manufacturing campaigns.

- Write master batch records and solution records for vector production.

- Participate in and/or initiate continuous improvement projects.

- Provide support for engineering studies of equipment or processes.

- Maintain safety and required training.

- Work to implement a culture of Right-First Time through partnerships with Operations and other functions on site, and provide leadership in the use of OE principles to optimize our technical and business processes.

- Execute scale-up and development of processes for non-GMP production, generation of process batch records, acquisition of raw materials, and the purchase, installation, and startup of new capital equipment.

- The incumbent will also be responsible for the mining and evaluation of process data, modeling, and the generation of reports to support manufacturing scale up.

QUALIFICATIONS

• Bachelor's degree with 3 plus years' experience in Upstream and Downstream biologics process development, technology transfer and/or bioprocess laboratory, pilot or manufacturing experience required.
• Demonstrated capability to work as a team member in a matrix development team.
• Prior experience in a Biological/Viral Pilot Plant or Commercial Manufacturing setting is desired. Ability to work under minimal supervision.
• Knowledge of upstream and downstream processing techniques required.
• Excellent oral and written communication skills.
• Operational knowledge of computerized systems.
• Prior experience with Single Use Bioreactors (50L and 250L scale) and Wave Bioreactors is highly preferable.

#LI-PFE

Other Job Details:

• Eligible for Employee Referral Bonus

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Research and Development