Staff Scientist- Upstream PD
$49K-$113K (Glassdoor est.)
As a Staff Scientist in Upstream Process Development, the candidate will be accountable for planning, development, optimization, execution and management of all assigned projects. Working with external clients, R&D, Quality Control/Quality assurance, and GMP Manufacturing, the successful candidate will provide technical expertise and scientific knowledge for design, development, optimization, and production of Protein Therapeutics, Vaccines and Viral Vectors. The successful candidate will contribute to the team based execution of projects, and will act as a primary lead in developing scalable and reproducible processes capable of GMP Production. The candidate will design experiments to meet specific criteria, support cGMP manufacturing operations and Technical Transfer, both internally and externally. Experience with Cell Line evaluation and development under cGMP or cGLP compliance is highly preferred.

The scientist in this position is expected to possess a clear understanding of the principles involved in various cell culture and fermentation methods and have experience in developing upstream process schemes. This position involves development of scale-up procedures for protein and viral based processes, optimization of procedures for optimal growth and productivity, and modification of existing procedures according to the federal regulations for making therapeutic products suitable for human injection. The successful candidate is expected to carry out the work independently with strict adherence to cGLP and cGMP compliance and to overcome challenges in meeting all regulatory requirements for making a safe product while maintaining the structural integrity and biological function of the therapeutic product. It is also necessary to interact with other departments involved in GMP manufacturing for the production planning, product testing and quality assurance for product release. Hands-on experience in process scale-up and transferring of upstream processes from PD to Manufacturing is desirable. Previous experience in a CMO or CRO is a plus.

Job Requirements

Develop robust, high-yield and scalable mammalian cell culture processes for the production of recombinant protein and viral candidates.
Develop and characterize cell lines, evaluate stability and suitability for large scale GMP manufacture.
Lead efforts to evaluate different cell culture media, feeds, and optimal feeding strategies to improve product yield and quality in suspension and monolayer cell culture.
Develop, optimize and scale-up fed-batch and continuous processes using Sartorius B-DCUII small glass bioreactors and BIOSTAT Flex-safe STR single-use bioreactors at 2L, 10L, 50L, and 200L scales, and iCELLis fixed-bed bioreactor.
Evaluate and optimize operation parameters to perform medium exchange, harvest and perfusion using ATF4 or ATF6 system at 50L and 200L production scales.
Interact with other departments involved in GMP manufacturing for production planning, testing and product release in a timely manner resulting in successful completion of projects.
Participate in technology transfer of processes to Manufacturing from external clients, and from internal process Development to Manufacturing.
Generate, manage, and maintain critical data in a highly organized manner in the form of notebooks, protocols, and batch records. Provide progress and developmental reports for assessment by clients, project team and management.
Review production batch records for GMP manufacturing, support and troubleshooting GMP production activities.
Perform experiments and deliver results under minimal supervision, and within tight time lines, to a prescribed budget for both internal / external client projects.

Travel Expectation

None

ABL, Inc. participates in E-Verify, an Internet-based system of the Department of Homeland Security (DHS) and Social Security Administration, that allows us to determine an employee's eligibility to work in the United States.

ADDITIONAL INFORMATION:
Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.
Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that “negotiable” is neither salary nor requirements. Salary commensurate with experience.

ABL, Inc. does not accept nor respond to unsolicited resumes from vendors, including recruitment agencies and search firms. Approved recruiting agencies must obtain prior approval from ABL, Inc. Human Resources in order to submit resumes to ABL, Inc. for consideration.
Advanced BioScience Laboratories
2.7
Advanced BioScience Laboratories
