Manufacturing Process Expert with Pharmaceutical Experience

24 uur geleden

Leiden, Zuid-Holland, Nederland Pharming Group Voltijd
Company Overview
Pharming Group, 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 are in early to late-stage development.

About Us
We prioritize our core values: 'We Care, We Collaborate, We Walk the Talk' which supports our focus on self-development, teamwork, leadership, and being results-oriented. In our growing organization, employees feel connected and engaged through our core values, enabling us to bring solutions to unserved rare disease patients and achieve strategic goals.

The Role
The Sr. Manufacturing Officer ensures that processes meet quality performance standards, GMP regulations, SOP procedures within agreed timelines at contract manufacturing organizations.

Main Responsibilities:
  • Design and control validation & transfer studies and transfers of manufacturing processes ensuring all processes are according to GMP regulations, required quality, SOP procedures within agreed timelines.
  • Advice as subject matter expert for processes of one or more Pharming drug substances and/or drug products.
  • 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:
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.

Salary and Benefits
We offer an excellent remuneration package, including:
  • A competitive salary around $80,000 - $100,000 annually depending on location and experience.
  • Holiday allowance (for NL).
  • A minimum of 30 vacation days.
  • An excellent pension plan.
  • Commuting allowance.

Learning Opportunities
You will join our Learning & Development program, offering a tailor-made development plan based on your personal and professional needs. We value a healthy life-work balance with a lot of flexibility.

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