Manufacturing Officer

1 week geleden

Leiden, Zuid-Holland, Nederland Pharming Group Voltijd

About Pharming Group

Pharming Group is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Our innovative portfolio of protein replacement therapies and precision medicines is in early to late-stage development, with a focus on self-development of our people, teamwork, leadership, and being results-oriented.

The Role

The Sr. Manufacturing Officer is responsible for ensuring that processes are executed according to required quality performance, GMP regulations, SOP procedures, and within agreed timelines at contract manufacturing organizations. This includes designing and controlling validation and transfer studies, as well as transferring manufacturing processes to ensure compliance with GMP regulations and required quality standards.

Key Responsibilities

  • Advise as a subject matter expert on processes for one or more Pharming drug substances and/or drug products.
  • Ensure that processes are executed according to required quality performance, GMP regulations, SOP procedures, and within agreed timelines at 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.

Requirements

  • 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 We Offer

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

We value a healthy life-work balance with a lot of flexibility and offer a permanent position with an excellent remuneration scheme. You will also join our Learning & Development program, which can offer a tailor-made development plan based on your personal and professional needs.

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