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.
The Sr. Manager or Associate Director of GMP Manufacturing for Fill Finish is responsible to lead a team of professionals while overseeing the GMP manufacturing process, through the broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the fill finish area of bioprocessing.
Key Responsibilities Include, but are not limited to:
- Independently plan and manage all aspects of tech transfer, fill finish and assembly operations as required
- Review vendor batch records and provide oversight for all specified manufacturing operations undertaken
- Throughout ensure cGMP compliance and all its related elements in documentation, reports and records
- Responsible for managing a team of professional production associates
- Oversight of GMP Fill Finish manufacturing associates and area
- Ensures the successful technical transfer of projects from the Tech transfer group to the GMP production group
- Works closely with the production staff to troubleshoot process and equipment problems
- Actively participates in all recruiting efforts to secure, onboard and develop new staff members
- Facilitates GMP and Safety training of GMP staff, with a focus on cross-training and continuous improve and production records
- Generates operational protocol(s) and production records
- Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives
- Liaise closely with Quality Assurance (QA) activities with respect to Drug Product manufacture, release, inventory management and distribution, and as pertains to vendor selection, qualification and monitoring and all other activities related to cGMP, GCP and ICH guidelines
- Will overview PD materials, equipment, methods for GMP compliance and scalability
- Expands the technical capabilities of the GMP Group
- Effectively communicates results of departmental work through team discussions and documentation
- Initiate non-conformances when identified and complete investigations to support on-time closure of deviation records
- Interacts with clients on presentations and project results; will also work closely with clients during initial and subsequent manufacturing campaigns
- Recommends equipment, supply purchases within the production areas
Education & Experience:
- Sr. Manager - HS/GED and 12 years GMP biologic manufacturing experience; B.S. in Engineering or Science discipline and 10 years of GMP biologic manufacturing experience; M.S. in Engineering in a Science discipline plus 8 years of GMP biologic manufacturing experience. Some or all of this experience should be in fill/finish processing.
- Assoc. Director - HS/GED and 14 years GMP biologic manufacturing experience; B.S. in Engineering or Science discipline and 12 years of GMP biologic manufacturing experience; M.S. in Engineering in a Science discipline plus 10 years of GMP biologic manufacturing experience. Some or all of this experience should be in fill/finish processing.
- Experience with GMP fill finish operations and sound understanding of the drug development process
- Minimum of 5 years of leadership experience required
Requisition ID : 1335