Staff Scientist- Upstream PD

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, and GMP Manufacturing, the successful candidate will provide technical expertise, contribute to the team based execution of projects, and 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 is also 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 cultures, optimization of procedures for optimal growth and productivity, and modification of existing procedures to meet project requirements. The successful candidate is expected to carry out the work independently and to overcome challenges in meeting all regulatory requirements for making a safe product while maintaining the structural integrity and biological function of the protein. 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.

Primary Job Functions:

• Identify, develop and optimize cell culture processes for the production of recombinant proteins and VLPs according to client specifications, applicable standards, and all necessary safety and regulatory requirements.
• Implement process controls and test methods to ensure that the process is scalable, reproducible, highly productive and capable of producing products of the acceptable quality.
• Contribute to the designing, planning, and trouble shooting of assigned projects and independently execute and implement the plans
• Communicate and collaborate with colleagues in other functions including Research and Manufacturing, QC, QA, as well as contractors, suppliers and clients to complete the tasks on time.
• Work with colleagues in cGMP manufacturing to ensure the upstream processes will be implementable in the cGMP manufacturing facility and responsible for process transfer to Manufacturing.
• Prepare and review batch records, development reports, and relevant regulatory documents (INDs, CMCs).

• This position requires a Ph.D. in Chemical Engineering, Biomedical Engineering or related engineering fields or in a life science discipline (Molecular Biology, Cell Biology, Microbiology or other) with at least 1 year of post graduate experience; a MS degree with 5 years of experience in Upstream Process Development role, or a BS degree with 9 years of experience. Experience with cGMP Manufacturing under cGMP compliance is a plus.
• Possess excellent interpersonal and communication skills, both verbal and written. Must be able to communicate effectively with all echelons of Management, colleagues, and clients.
• Must be able to lift up to 50 lbs.
• Intermediate computer skills using MS Office (Word, Excel) preferred.
• Capable of working in a fast-paced environment with a tight timeline, and is flexible and able to adapt to changes.
• Task and Team-oriented, analytical, organized, detail-oriented, self-motivated, and ability to multi-task.
• Meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant. Employment is contingent upon favorable background, reference, and pre-employment physical including drug screen.

ABL, Inc. requires all new hires and contractors to be fully vaccinated for COVID-19 prior to the first date of employment starting on December 8, 2021. ABL, Inc. is an equal opportunity employer and will provide reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.