Manufacturing Associate II GMP Purification:

Job Description
Requires knowledge and application of the theories and principles utilized to solve operational, as well as routine tasks in the purification of proteins, antibodies, etc. for Phase I/II GMP manufacturing. Mature professional capable of independent work at times. Requires the ability to produce results in a fast-paced environment, under minimal supervision while leading/managing junior staff. The ability to lift 40 lbs unassisted will be required at times. Shift work and/or weekend work may be required at times.

Minimum Knowledge and Skills Required

High School diploma and >5 years experience in the isolation and purification of proteins, antibodies, etc. Experience with chromatography equipment, columns, TFF, CIP procedures and of those processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity).
Or Bachelorís degree in engineering or sciences and >2 years experience.

Major Duties, Responsibilities and Communication

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

Will participate in facility expansion, validation.

Hands-on experience with a good understanding and knowledge of isolating and purifying proteins from microbial and cell culture processes (chromatography, TFF).

May work in process development at times to transfer purification projects into GMP.

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

Will work under general supervision to meet project goals.

May assist management with GMP and safety training of purification staff.

Participates in troubleshooting processes and equipment problems.

May interact with clients during initial and subsequent manufacturing campaigns.

Generates operational protocol(s) and production records.

Works closely with purification 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.

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)

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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