Manufacturing Associate II GMP Microbial/Cell Culture:
Requires 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. Lifting up to 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 microbial (bacteria, yeast) and cell culture production (mammalian, insect). Experience with fermentors and cell culture reactors and of those processes to produce bulk biologics (proteins, polysaccharides, antibodies, etc.).
- Or Bachelor’s degree in engineering or sciences and >2 years experience.
- Or Master’s degree in the biopharma related sciences.
Major Duties, Responsibilities and Communication
- Decisions or recommendations consistently result in favorable project results and client satisfaction.
- May participate in facility expansion, validation.
- Has a good understanding and knowledge of microbial fermentations and cell culture techniques and processes.
- Has hands-on experience in the operation of GMP mfr equipment such as bioreactors, seed train equipment, TFF skids, depth filtration.
- Participates in troubleshooting process and equipment problems.
- 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.
- May interact 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.
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)
- 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.
Primary candidates ONLY. No recruiting agencies.
Interested parties are encouraged to mail their CV with a cover letter to:
Paragon Bioservices, Inc.
Attn: Human Resources
801 W Baltimore St
Baltimore, MD 21201