1+ months

Senior Associate Scientist

Pfizer
Morrisville, NC 27560
Apply Now
Apply on the Company Site
**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 the technical transfer of processes into the vector manufacturing facility. The Tech Transfer Scientist/Engineer 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 scale-up and development of Pilot Plant 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. 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 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 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 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 RDRU manufacturing.

- Liaise with site functions - Manufacturing, Process Development, Logistics Operations, Planning, QA, QC, Operations, Regulatory Affairs to support the project implementation.

- Provide raw material forecasts for manufacturing campaigns.

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

- Monitor the progression of the vector campaigns and provide data summaries to stakeholders.

- 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 (inoculum expansion, cell culturing, perfusion) 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**

BS or MS degree in a biological or engineering (preferred) discipline - Biotechnology, Biochemistry, Biochemical Engineering, or equivalent.

3-7 plus years' experience in **Downstream** (cell culture/tissue culture) biologics process development, technology transfer and/or bioprocess laboratory, pilot or manufacturing required (will also consider experience in the chemical process industry). 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 fermentation and/or downstream processing techniques. Excellent oral and written communication skills. Operational knowledge of computerized systems.



Prior experience with Single Use Bioreactors is highly preferable. As is QC assay skills.



\#LI-PFE



**Other Job Details:**



+ Eligible for Employee Referral Bonus



**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.



Research and Development
Posted: 2020-02-25 Expires: 2020-04-27

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Senior Associate Scientist

Pfizer
Morrisville, NC 27560

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast