Director, Manufacturing - GMP Downstream

Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

An amazing opportunity to gain experience in the gene therapy and vaccine space, this opportunity will grow and develop a new team for a state-of-the-art manufacturing facility in Harmans, MD near Baltimore-Washington Int'l airport. Experiences include not only the leadership to high performing teams but the opportunity to take part in capital expansions.

The Director or Sr. Director, Manufacturing for the Downstream Processing group is responsible for leading teams 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 production of bulk biologics.

Key Responsibilities include but are not limited to:

• Responsible for managing multiple teams of leaders and associates across multiple campaigns and shift
• Oversight of downstream production operation including an understanding of isolating and purifying proteins from microbial and cell culture processes.
• Ensures the successful technical transfer of projects in partnership with the Tech transfer group
• Works closely with the production staff to troubleshoot process and equipment problems while ensuring appropriate and proactive client and internal stakeholder communication
• Will oversee and ensure compliance when creating, revising, and editing procedures and specs as needed
• Leads by example, keeping in mind organizational values, policies and goals.
• Proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding and OJT is a positive experience.
• Ensures the proper processes are in place for GMP and Safety training of staff, with a focus on cross-training and continuously improves production records
• Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives
• Effectively communicates results of departmental work through team discussions and documentation
• Interacts with clients on presentations and project results; will also work closely with clients during initial and subsequent manufacturing campaigns

Experience & Education:

• 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 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).
• Must have experience in a CDMO or CMO environment.
• Minimum of 6 years of leadership experience required.

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.

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