Scientist Drug Product development

About Pharming
Pharming Group N.V. (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.

Purpose of the role:

The Scientist in Drug Product Development plays a vital role in designing and overseeing the development and manufacturing of Pharming's new products, encompassing solid, liquid, and semi-solid dosage forms from Phase 1 through commercial approval. This role involves close collaboration with contract organizations.

Responsibilities include leading the development, scale-up, and validation of drug product manufacturing processes while ensuring adherence to quality regulations and meeting assigned tasks within agreed timelines.

Areas of responsibility:

• Oversee/contribute to the design of drug product development for Pharming's products according to the target product profiles.
• Advice as subject matter expert for drug product development, scale-up and validation of Pharming drug products (transfer dependent on complexity).
• Manage contract organizations for outsourced drug product manufacturing development, scale-up and validation activities.
• Troubleshoot drug product manufacturing and formulation-related issues during development and provide innovative solutions to overcome challenges.
• Plan and prioritize work in collaboration with the CMC team to ensure deadlines are met and costs remain within budget.
• Generate scientific reports, documentation, and presentations to communicate drug product development progress and findings to internal teams and external stakeholders.
• Ensure transfer of knowledge and processes to internal (e.g. MCS) and external stakeholders (e.g. CMO).
• Participate in R&D project teams, keep the scientific oversight of the manufacturing development activities.
• Write development and validation reports and relevant CMC sections of the dossier (IMPD/IND and/or NDA/MAA) and respond to regulatory questions.
• Troubleshoot and report results when deviations from the drug product production process occur and the activity is assigned to R&D.
• Stay abreast of emerging trends, technologies, and regulatory requirements in pharmaceutical formulation and drug delivery.
• Can be involved in Business Development projects to estimate the impact on manufacturing packages.

Knowledge:

•  A Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related discipline.
• Proven experience in pharmaceutical formulation development, preferably in an industry setting.
• Knowledgeable of regulatory guidelines (EMA, FDA, ICH) and current Good Manufacturing Practices (cGMPs) 
•  Excellent knowledge of English language, both verbal and in writing

Experience:

• Min 5 years of functional experience
• Experience in Pharma/Biotech is a plus

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
• 8.33% 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.

Apply for the job
Does this sound like you and do you want to join our team? Then we'd love to hear from you!

We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.