Manufacturing Process Development Scientist - Molecular Biologist in Pittsburgh, PA at Apex Life Sciences

Date Posted: 11/7/2018

Job Snapshot

Job Description


Apex Life Sciences is recruiting for a Manufacturing Process Development Scientist - Molecular Biologist for a direct hire permanent position with a clinical stage biopharmaceutical company here in the Pittsburgh area.

The Process Development Scientist-Molecular Biologist/Biotechnologist will modify primary cells to convert them to continuous or semi continuously dividing cells (extended-life, immortalized cells). This person will work closely with a biochemical engineer to scale up these extended life cells for use in cGMP production. In addition, this person will collaborate with the R&D department to discover cells or cell lines that may be appropriate for cell-based biological assays.

 

Responsibilities:

• Creates an extended-life or immortalized cell that is appropriate for cGMP manufacturing of products.

• Obtains a complete understanding of the primary cells that may be used for cellular therapy.

• Works with the biochemical engineer and R&D group to develop cell manufacturing methods, including scale-up, yield optimization, and control strategies for anchorage-independent cells.

• Assists with the development of protein purification/concentration processes of complex biological solutions.

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

• 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 working understanding of 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 manufacturing and regulatory departments to achieve company goals.

• Explores alternative methods of scalable, cell culture processes.

• Performs molecular biological assays.

• 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

• Maintenance of sterile culture conditions

• Creation and evaluation of biochemical, molecular biological, cell-based 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

• Apply appropriate statistical methods for designing experiments, analyzing and presenting data

• 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

If interested, please apply online at: www.apexlifesciences.com and email Pittsburgh@apexlifesciences.com

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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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