External Manufacturing Technical Project Lead

Opella-posted 17 days ago
Full-time • Mid Level
Chattanooga, TN
5,001-10,000 employees
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The External Manufacturing Technical Project Manager provides manufacturing support services to Contract Manufacturing Organizations (CMO) related projects and manages assigned new products from concept to launch. The candidate will serve as the Subject Matter Expert for new products and production related initiatives at CMO’s. As a primary technical contact, support the interface of CMO with Opella operational personnel in an effective and proactive way; always working in a positive, efficient, and effective way to address business objectives.

  • Manage CMO produced new products, package/formula changes, and technical transfers of existing products and processes from concept to launch
  • Participate in cross functional teams in the selection of new CMOs or the use of an existing CMO for a new project.
  • Coordinate with team members representing Quality Assurance, Product Development, Procurement, and Operations to evaluate and recommend CMOs
  • Develop validation strategies for CMO produced products, and review and approve validation protocols and summary reports.
  • Provide ongoing technical support for currently marketed products produced at CMO’s.
  • Perform expert review of all change control documentation for CMO produced products and be able to assess impact of proposed changes on the product’s validated state.
  • Coordinate with activities of Marketing, Product Development, and Operations Department with CMOs in the development of product, product transfers and packaging for new and existing CMO manufactured products.
  • Manage projects, recurring project meetings; issuing meeting notes and action items for all projects managed.
  • Prepare and issue project Gantt charts; work with cross-functional project team members to maintain project schedule (identifying any shortfalls or issues in a pro-active fashion).
  • Review and approve Annual Product Reviews for all externally manufactured products.
  • Other duties as assigned.
  • BA or BS in Science or Engineering or a related field.
  • Two to Five (2-5) years technical support experience in an FDA regulated environment- preferably within a Consumer Healthcare Company.
  • Strong technical acumen in various dosage form delivery systems (oral solids, liquids, emulsion systems, aerosols, powders, etc.)
  • Strong working knowledge of various packaging systems (bottles, tubes, aerosols, thermoforming, etc.).
  • Excellent written and verbal communication skills with great attention to detail.
  • Experience with Microsoft Office Suite, to include: Excel, Word, Outlook, and PowerPoint.
  • Travel as needed to address the organization’s needs for External Manufacturing. - up to 10%
  • Team focus with a proven track record of cross functional team leadership.
  • Good negotiation skills with proven record of success.
  • Relationship building skills as external liaison to the C(D)MO
  • Customer service mindset in working with commercial operations and other internal/external functions.
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