Staff Scientist-Downstream Process Development
$49K-$113K (Glassdoor est.)
ABL is seeking a Staff Scientist for the Downstream Process Development team. The candidate will be responsible for planning, development, and optimization, execution of assigned commercial and government client downstream development tasks. Working with external clients, R&D, Quality Control/ Quality Assurance and GMP Manufacturing, the scientist will provide expertise and scientific leadership for design, development, optimization, and production of protein therapeutics and viral vectors. The successful candidate will contribute to the team based execution of projects.

The main responsibilities will include but not limited to follows:
Develop robust, high-yield and scalable purification process (recombinant protein, virus and virus like particles) for Vaccine Development of Phase I/II candidates.
Develop, optimize and scale-up protein purification methods to meet cGMP and Regulatory Compliance using Design of Experiment (DOE) methods.
Lead efforts to evaluate different resins, filters, and analytical methods pertinent to purification development activities.
Perform experiments using AKTA series Chromatography skids, TFF systems, and industry standard Harvest methods scale.
Interacts with other departments involved in GMP manufacturing for planning production, testing and product release in a timely manner resulting in successful completion of projects.
Participate in technology transfer of processes to manufacturing and from external clients, and from process development to manufacturing.
Generate, manage, and maintain critical data in a highly organized manner in the form of notebook, protocol and SOP. Provide progress and developmental reports for assessment by clients.
Develop and draft 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 internal / external client projects.

Job Requirements

This position requires a PhD in a life science discipline (Biochemistry, Analytical Chemistry Protein Chemistry or other related discipline), with 3-5 years of experience in Downstream Process Development, or an MS with 5-10 years’ experience, or a BS degree with more than 10 years of experience.
Experience with cGMP manufacturing under cGMP/cGLP compliance a plus.
Experience with AKTA purification systems.
Computer skills using MS Office (Word, Excel, and Power Point).
Proven leadership skills.
Possess excellent interpersonal skills, both communications and written. Must be able to communicate effectively with all echelons of Management and staff.
Task & Team-oriented, analytical, organized, detail-oriented, self-motivated & ability to multi-task.

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
