Scientist I/II Upstream Process Development

Industry

Pharmaceuticals

Advert ID

FOX_BBBH50165

Location

Durham

Job Type

Permanent

Hours

Full-Time

Salary Range

Up to USD85000.00 per year

No. of Openings

1

Branch Information

Raleigh Engineering - (USA) 701 Corporate Center Drive Suite 375 NC Raleigh , NC 27607 Phone : 919-755-5804

ContactNumber

919-755-5804

Job Description

JOB SUMMARY:

Biopharma company seeks to fill a role for Cell Culture Process Development Scientist. This person will lead and assist in cell culture and harvest of mammalian cell lines (mainly CHO variants) in support of process development, scale-up, and technology transfer to cGMP manufacturing.



JOB RESPONSIBILITIES:





* Supports product development efforts in the process and manufacturing areas.

* Conceptualizes and proposes process development and manufacturing based on biopharmaceutical data.

* Provide technical support for clinical manufacturing and product testing.

* Works toward developing a broad knowledge of state of the art scientific principles, theory of cGMP and other regulatory requirements.

* Act as spokesperson on development programs and interact positively and productively with clients.

* Lead and support the team in the set-up, operation, and associated analysis of cell culture and bioreactor processes including bioreactor preparation, autoclaving, inoculation, sampling, feeding, data entry, and data analysis for shake flask and various scale bioreactors (ambr15, ambr250, 3 L & 15 L glass bioreactors, 50 L and 200 L Xcellerex single-use bioreactors).

* Lead in maintaining and monitoring process development experiments in shake flasks and bioreactors. Required to perform calculations for growth date, specific productivity, bioreactor agitation and gassing scale-up.

* Maintains a cell culture-specific project plan, including raw materials and equipment availability, in preparation of laboratory and pilot- scale runs.

* Responsible for producing high quality documentation and client reports suitable for publication and regulatory requirements.

* Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.







MINIMUM REQUIREMENTS:



* Degree within Chemical Engineering, Biotechnology or related area:



* Bachelor's degree with 5+ years' experience

* Master's degree with 3+ years' experience

* Ph.D. with 0-2 years' experience



* Working knowledge of mammalian cell culture.