Vacature Scientist Drug Product Development

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 (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.

Functie:	scientist drug product development
Startdatum:	19-04-2024
Ervaring:	Ervaren
Educatielevel:	WO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met Pharming Group via onbekend of onbekend. Of bezoek hun website onbekend.