Sr Manufacturing Officer – Pharming Group – Leiden

31 oktober 2024 0

  • Leiden

Pharming Group

About Pharming
Pharming Group (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.

Our Culture
Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.

The role: 

The Sr. Manufacturing Officer ensures that the processes are executed according to the required quality performance, GMP regulations, SOP procedures, within the agreed timelines at the contract manufacturing organizations.
The Sr. Manufacturing Officer designs and controls both validation & transfer studies and the actual transfers of manufacturing processes ensuring all processes are according to GMP regulations, required quality, SOP procedures within agreed timelines at contract manufacturing organizations.

  • Advice as subject matter expert for processes of one or more Pharming drug substances and/or drug products
  • To ensure that the processes are executed according to the required quality performance, GMP regulations, SOP procedures, within the agreed timelines at the contract manufacturing organizations.
  • Transfer and validate processes of one or more Pharming drug substances and/or drug products in commercial phase.
  • Investigate and troubleshoot when deviations occur with processes and report the investigation.
  • Communicate with CMOs to ensure timely, reliable test results.
  • Represent MCS in projects for advice and contribution on processes of one or more Pharming drug substances and/or drug products.

    • Your Profile:

  • HLO / MSc or equivalent in (Chemical) Engineering, Organic chemistry, Pharmacy, Biochemistry, Life Science & Technology, Biology
  • Understanding of pharmaceutical development (biologics, small molecules), documentation requirements, systems, and equipment knowledge
  • Knowledgeable of Current Good Manufacturing Practices (cGMPs) and regulatory guidelines (EMA, FDA, ICH)
  • Minimal 3 years of relevant working experience

    • What you’ll get in return
    We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including:

  • A highly competitive salary
  • holiday allowance (for NL)
  • A minimum of 30 vacation days
  • An excellent pension plan
  • Commuting allowance

    • You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs. Learning opportunities are everywhere, in all forms imaginable and we want to create learning memories for all “Pharmers”.

    Also important! We truly value a healthy life-work balance with a lot of flexibility.

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