Manufacturing Associate III, GMP Microbial/Cell Culture:

Job Description
This individual requires broad knowledge and application of the theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II GMP manufacturing. Mature professional capable of independent work at times. Develops creative solutions to problems using available theories and knowledge. Requires the ability to produce results in a fast-paced environment, under minimal supervision while leading/managing junior staff. Lifting up to 50 lbs unassisted will be required at times. Shift work and/or weekend work may be required at times.

Knowledge/Technical Expertise

High School Diploma and >7 years experience in microbial (bacteria, yeast) and cell culture production (mammalian, insect). Extensive experience with fermentors and cell culture reactors and of those processes to produce bulk biologics (proteins, polysaccharides, antibodies, etc.).

Or Bachelorís degree in engineering or sciences and >4 years experience.

Or Masterís degree with > 2 years experience as described above.

Major Duties, Responsibilities and Communication

Decisions or recommendations consistently result in favorable project results and client satisfaction.

Will heavily participate in facility expansion, validation.

Has excellent understanding and knowledge of microbial fermentation and cell culture techniques and processes.

Will be the shift leader during operation of microbial and/or cell culture processes (media/buffer prep, seed prep, culturing, harvest by TFF or centrifugation, equipment CIP).

May work in process development to transfer production projects into GMP.

Has begun generating internal or external documents (SOPs, BRs).

Works under general supervision to meet project goals.

Will assist management with GMP and safety training of manufacturing staff.

Will recommend equipment, supply purchases within the production areas.

Takes a lead role in troubleshooting process and equipment problems.

Interacts with clients during initial and subsequent manufacturing campaigns.

Generates operational protocol(s) and production records.

Works closely with production management to initiate new manufacturing projects and helps develop processes/techniques to meet contract objectives.

Will work closely with various departments at Paragon and offer assistance as needed.

May attend local scientific meetings and national training courses as a company representative.

Measurement of Performance

Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team.

Timeliness and accuracy in completion of projects and paperwork. (quantity of work)

Contributions to projects beyond general responsibilities. (quality of work)

Identification of problem areas affecting operations. (knowledge/problem solving)

Offers suggestions for correcting problems and for improving operations. (knowledge/problem solving)

Exercises good judgment in dealing with operational problems. (knowledge/problem solving)

Understanding of theory, rationale behind tasks performed. (knowledge).

Demonstrated understanding and adherence to Paragon policies, safety procedures and the cGMPs.

Ability to succeed in a team oriented environment under very dynamic (changing) conditions.

Company

Paragon Bioservices

Job Code

State or Province

Maryland

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