R&D Process Development Scientist-Biochemical Engineer in Pittsburgh, PA at Apex Life Sciences

Date Posted: 11/7/2018

Job Snapshot

Job Description


Apex life sciences is recruiting for a Process Development Scientist-Biochemical Engineer for a direct hire permanent position with a clinical stage biopharmaceutical company here in the Pittsburgh area

 

The R&D Process Development Scientist-Biochemical Engineer will develop manufacturing processes for cell-based products using appropriate cell culture methodologies. This person will work closely with the Research and Development department to scale up processes discovered by R&D to concentrate, formulate and otherwise modify the existing product. The Process Development Scientist will work as part of a team consisting of R&D scientists and Manufacturing to scale-up bioreactor technology, identify and assess alternative large-scale cell culture technologies and address potential improvements in the existing systems. All work supports the goal of technology transfer to the manufacturing department for cGMP manufacturing.

Responsibilities:

• Develops cell manufacturing methods, including scale-up, yield optimization, and control strategies for anchorage dependent cells.

• Develops protein purification/concentration processes of complex biological solutions.

• Develops and/or assist in the development of drug delivery formulations.

• Develops alternative methods to remove and/or inactivate viruses in biological solutions.

• Designs, executes, and analyzes experimental results to define process variability and critical process parameters.

• Writes formal development reports for use in FDA regulatory submissions.

• Authors formal technology transfer plans for the transition of processes and methodologies to the manufacturing department.

• Maintains current training on client’s manufacturing Standard Operating Procedures (SOP’s), practices, and specifications.

• Cultures and evaluates new cell line as candidates for future production.

• Assists and/or takes responsibility for troubleshooting and root cause analysis when necessary.

• Maintains proper documentation of all experimental procedures and results.

• Prepares presentations of ideas, data, conclusions, processes, and outcomes for discussion with team.

• Works closely with the R&D and regulatory departments to achieve company goals.

• Scales-up cell culture processes.

• Explores alternative methods of scalable, cell culture processes.

• Troubleshoots ongoing manufacturing processes.

Required:

• Experience growing and maintaining primary, anchorage-dependent anchorage-independent cells

• Experience with instrumentation for assessing growth rates and quantitating the viability and health of cells

• Experience scaling-up cell culture and investigating various cell culture technologies

• Experience with cell culture instrumentation; e.g., oxygen and pH controllers and off-line analysis of metabolic parameters

• Maintenance of sterile culture conditions

• Creation and evaluation of biochemical and chemical assays

• Experience with or basic understanding of requirements for interdepartmental technology transfer

• Aseptic technique and proper handling of human tissue and cell specimens

• Working knowledge of statistics regarding experimental design, analysis and presentation

• Working knowledge of Microsoft Office applications, graphing software, statistical software, and presentation of data

• Scientific report writing

• Keen understanding of protein biochemistry and analytical techniques

• Understanding of microbiology, virology and other adventitious agents

• Working knowledge of cellular transfections and molecular biological techniques

• Familiarity with development and commercialization of biologic products

• Insight to proprietary approaches to research

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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