Sr. Director, MS&T / Technical Operations

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP)
  3. United States
Raleigh, USA
Posting date: 10 Feb 2021
QA.JL.35571C

Proclinical is working with a leading biotechnology company that focuses on advanced therapies to treat a variety of rare diseases. Our client is urgently searching for a Remote Senior Director of MS & T / Technical Operations that will lead the development and implementation of all last stage product development at chosen external CDMO partners.

Job Responsibilities:

  • Primary focus will be on contract manufacturing partners and manufacturers of related critical components.
  • Will act as the company's senior technical expert for assigned contract manufacturers and suppliers. Coordinate and lead key activities such as experimental trials, process performance qualification batches, process changes and scale-up.
  • Work closely with the quality unit in reviewing and approving protocols, master batch records, component specifications, development reports etc.
  • Establish KPI's with external manufacturing partners.
  • Monitor and ensure supplier manufacturing/development performance.
  • Coordinate and manage regular business reviews with partners. Travel as needed to manufacturing partners to ensure alignment with the company's expectations.
  • Coordinate internally to ensure seamless flow of information to and from CDMO partners. Establish strong working relationships with Regulatory and Quality functions.
  • Lead internal teams on key projects such as supplier selection and process improvements.
  • Provide support as needed for regulatory filings.
  • Provide planning and inventory management of critical manufacturing components at external manufacturing sites on an ongoing basis.
  • Provide manufacturing support during critical campaigns at external manufacturing sites as and when required.
  • Support all technical transfer developed late stage clinical programs to the Commercial Support group

Skills and Requirements:

  • BS/MS in engineering or scientific discipline
  • Ph.D preferred
  • 15+ years in manufacturing management
  • 1-3 years of Gene Therapy or Biologics Manufacturing
  • Ability to communicate dynamically at all levels
  • Strong relationship management experience
  • Experience in developing, managing and operating external manufacturing programs
  • Experience managing activates and delivering value based solutions
  • Expert influencing and negotiation skills
  • Good understanding of broader business objectives and the implications of strategic planning/partnering
  • Ability to deal with ambiguity and corresponding ability to make decisions or recommendations on incomplete information

If you are having difficulty in applying or if you have any questions, please contact Matt Phelan at (+1) 646-779-7968.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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