Manager/Sr. Manager, Manufacturing - Fill / Finish

Location
Baltimore, MD, US
Posted
Sep 04, 2019
Ref
1704
Hotbed
BioCapital
Required Education
Associate Degree
Position Type
Full time
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.

The Manager 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

Skills & Behaviors:
  • Has considerable knowledge/expertise relevant to fundamental lab technologies, particularly focused on protein expression, isolation and analysis
  • Has excellent understanding and knowledge of all fill finish operations including aseptic hand filling and automated filling of liquid vials
  • Has demonstrated track record of managing hands-on cGMP manufacturing operations
  • 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

Education & Experience:
  • B.S. in Engineering or Science discipline and 8+ years of GMP biologic manufacturing experience OR M.S. in Engineering in a Science discipline plus 6+ 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 3 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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