A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The selected candidate will join the Bioprocess R&;D organization where we are building industry leading capabilities in process development and cGMP clinical manufacture of gene therapy therapeutics in Durham, NC.
This position is responsible for taking an active role in the technical transfer of processes into the clinical manufacturing facility and/or transfer of processes to commercial manufacturing or a CMO. The Tech Transfer Scientist/Engineer will be part of a multi-disciplinary team which is responsible for the transfer and execution of cGMP operations of virus production and purification, resulting in the production of clinical supplies in support of Pfizer’s Biotherapeutics portfolio.
Qualified candidates will have experience in gene therapy, biological, and/or vaccine process development, technology transfer, scale up, and cGMP Clinical Manufacturing. The candidate must demonstrate the technical acumen and intrapersonal 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 ultimately ensure the successful cGMP clinical manufacturing of gene therapy medicines.
- Lead meetings that facilitate the Tech Transfer process.
- Identify, communicate, track, and hold team members accountable for project deliverables.
- Evaluate lab-scale processes and define the scaled up process for the clinical production facility.
- Interface with development scientists and propose options to resolve process fitting issues.
- Capture knowledge from donating site through review of documentation, observation of batches, compiling process descriptions and flow diagrams, interacting and training with donating 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 clinical manufacturing.
- Participate in Gap Analyses and Risk Assessments to support the tech transfers.
- Write Tech Transfer and Validation/Verification Documents.
- Liaise with site functions – Manufacturing, Process Development, Logistics Operations, Planning, QA, QC, Operations, Regulatory Affairs to support the process transfer and project implementation.
- Provide raw material forecasts for clinical campaigns.
- Write master batch records and solution records for clinical production.
- Monitor the progression of the clinical campaigns and provide data summaries to stakeholders.
- Write campaign summaries and provide information for regulatory filings.
- Participate in and/or initiate continuous improvement projects.
- Provide support for engineering studies of equipment or processes.
- Maintain safety and cGMP 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.
- Support manufacturing deviation investigations.
- Execute scale-up and development of Pilot Plant Downstream (column packing, purification, and TFF) 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.