Research Associate

• The Research Associate/Senior Research Associate will execute ongoing process development activities for the clinical manufacturing of gene therapy products in compliance with all current regulatory and corporate quality guidelines.

• This individual collaborates with all supporting groups and departments to ensure technical and operational requirements are established and maintained in order to meet all relevant company, site and departmental development goals.

Job Responsibilities: 

• Carry out experiments supporting the generation of a purification strategy for the production of viral gene therapy vectors. The individual will analyze/interpret results and may recommend additional experiments that expand process knowledge and improve process performance.

• Participate in process scale-up activities, including execution of manufacturing scale runs; may act as a subject matter expert supporting the transfer of process technology to both internal and external clinical manufacturing groups.

• Author protocols, technical reports, data analysis summaries, and SOP's.

• Use scientific principles and experiential knowledge to solve complex problems in creative and practical ways.

• Apply state-of-the art principles and theories in area of responsibility to develop processes and advance programs. Evaluate new technologies and make recommendations for their implementation in Gene Therapy process development.

• Adheres to and supports all safety programs by ensuring personnel safety training is completed and safety equipment is available

Minimum 3 years of relevant experience in the purification of biologics.

Must have demonstrated skills and working knowledge of the unit operations associated with biologics manufacturing - column chromatography (operation of manual and automated chromatography systems), TFF, depth filtration).

Preferred Qualifications:

Ability to operate in a dynamic, fast-paced, safety conscious, multi-product development and manufacturing environment with shifting priorities. Strong commitment to accountability for self and departmental staff for completion of objectives in accordance with established plans.

Education:

Research Associate: Bachelor s degree and 2 or more years. Master s and 0-2 years; Senior Research Associate: Bachelor s degree and 5 or more years. Master s and 3 or more years

Best Regards,

Anuj Mehta

(973) 967-3402

Morristown, NJ 07960