Associate Director, Manufacturing - Downstream GMP Bioprocess

Paragon Bioservices Inc. - Harmans, MD

Paragon Bioservices, Inc. (PBI) is a growing biopharmaceutical contract development and manufacturing organization with an internationally recognized tradition of quality and service. PBI 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 Associate Director of Manufacturing for the Downstream Processing group is responsible to leading multiple teams of professionals while overseeing the GMP manufacturing process, through the 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/II GMP manufacturing.

Key Responsibilities include but are not limited to:
Responsible for managing multiple teams of Supervisors, Team Leads & Associates across multiple campaigns and shifts
Oversight of downstream production operation including an understanding of isolating and purifying proteins from microbial and cell culture processes. Works closely with the production staff to troubleshoot process and equipment problems
May create, revise, and edit SOP, SMPs, and specs as needed
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
Will review 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 Other duties as assigned
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

Skills & Behaviors:
Has a demonstrated track record for managing (hands-on) purification operations under cGMPs.
Experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC) to maintain internal and project schedules
Ability to produce successful results in a fast-paced environment, under minimal supervision while leading a team of professional production associates
Creative individual with excellent troubleshooting skills as they relate to scientific and engineering principles

Experience & Education:
HS Diploma or Associates Degree & 14 years of GMP biologic manufacturing experience OR B.S. in Engineering or Science discipline and 12+ years of GMP biologic manufacturing experience OR 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 downstream processing.
Downstream experience includes 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 6 years of leadership experience required (HS Diploma/Assoc degree); 4 years leadership (Bachelor or Master’s degree).

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.