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Team Lead, Materials Control - Shipping

Employer
Paragon Gene Therapy, a unit of Catalent Biologics
Location
Harmans, MD, US
Start date
Apr 5, 2019

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Job Details

Paragon Bioservices is a contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. We provide industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-expressrecombinant proteins and oncolytic viruses. Paragon's scientists, engineers, quality experts, manufacturing operators and program managers are experts working with biologics from research and process development to GMP manufacturing for clinical trials and commercial launch

The Team Lead, Shipping is responsible for supporting the overall GMP materials control/warehousing operations for a GMP phase I through commercial biopharma manufacturing facility. The position will be responsible for acting as a subject matter expert (SME) in shipping; reviewing documentation and ensuring all products are verified before export to our clients in support of manufacturing operations in a given Paragon site. The position will be expected to cross train in areas outside of direct responsibilities to provide support across all supply chain activities.

Duties & Responsibilities:
  • Provide guidance to and be a resource for assigned SME areas to all employees.
  • Generates or review GMP documentation associated with assigned SME areas including deviations, SOP's, work instructions, or performance reports.
  • Assessing areas of assigned SME operation on a continuing basis and providing recommendations for process improvement.
  • Provide Tier one issue resolution for assigned areas of SME responsibility prior to escalation to management.
  • Support cGMP compliance across both supply chain and broader company operations
  • Represent assigned SME areas during audits.
  • ERP software activities - Supply chain related data management including SME level understanding of ERP function relating to areas listed above as well as master data that affects all supply chain areas.
  • Shift operations - responsible for assuring continuity of supply chain activities during shift/weekend coverage acting as a point of contact for all internal customers assuring business needs are addressed.


Skills & Technical Expertise:
  • Has a good understanding of supply chain related operations;
  • Experience with ERP software systems.
  • Must have a robust understanding of compliance activities in a GMP environment including training, authoring SOP's, deviations, etc.
  • Experience and a thorough understanding in one or more SME areas of responsibility listed above.
  • Accuracy and thoroughness in the completion of documentation is critical.
  • Ability to produce results in a fast-paced environment, under minimal supervision coordinating with internal team members and customers as needed.
  • Some areas of operation require the ability to carry up to 40 lbs.


Education & Experience:
  • Bachelor level degree with 2 years or relevant experience or 5 years of relevant experience
  • Experience with electronic supply chain software
  • Relevant certifications a plus


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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Company

Company info
Location
801 West Baltimore Street
Suite 302
Baltimore
Maryland
21201
US

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