Sr. Manager, Manufacturing - Downstream
Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
Key Roles & Responsibilities:
- Requires broad knowledge and application of the theories and principles utilized to solve operational, as well as routine tasks in the purification of a variety of proteins, antibodies, etc. for Phase I/IIGMP manufacturing.
- Mature professional capable of independent work.
- 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.
- Decisions or recommendations consistently result in favorable project results and client satisfaction.
- Will heavily participate in facility expansion, validation.
- Has a demonstrated track record for managing (hands-on) purification operations under cGMPs.
- Has excellent understanding and knowledge of isolating and purifying proteins from microbial and cell culture processes.
- Will recommend new hires for the GMP Purification group.
- Has begun generating internal or external documents.
- Works under general supervision to meet project goals.
- Will facilitate GMP and safety training of manufacturing staff.
- Will recommend equipment, supply purchases within the production areas.
- Works closely with purification staff to troubleshoot process and equipment problems.
- Will interact with clients on presentations and project results. Will also work closely with clients during initial and subsequent manufacturing campaigns.
- Generates operational protocol(s) and production records.
- Works closely with senior 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.
Education & Experience:
- Bachelor’s degree in engineering or sciences and 10 years experience in
- the isolation and purification of proteins, antibodies, etc. Extensive experience with chromatography equipment, columns, TFF, CIP procedures and of those processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity). Minimum of one year experience in a supervisory role is required.
- Or Master’s degree with > 4 years experience as described above.
Requisition ID : 1180