Technical Project Lead

vor 7 Monaten

Basel, Schweiz CTC Resourcing Solutions Vollzeit

**Technical Project & Product Lead - Drug Product (Parenteral/Combination Product) - 5759 ADA**

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a **Technical Project & Product Lead - Drug Product (Parenteral/Combination Product) **for a **12-month contract** (with **high possibility of** **extension**) in **Basel**, **Switzerland**.

**Main Responsibilities**:

- Lead the technical development of several **parenteral and/or combination** **product** **small** **molecule** projects **from early phase development** activities **up to commercialization**, including production scale up with external partners.
- Lead and manage development, analysis, and production of parenteral dosage forms and/or combination products, including clinical and market forms.
- Ensure sufficient and timely supplies for development projects based on input from the Global Supply Chain, CMC, Project and/or Life Cycle management functions.
- Lead the collaboration with external development partners with special emphasis on cost efficiency, timelines and scientific quality.
- Lead the technical drug product development activities: plan, organize and administer the different aspects of the technical activities required for development, scale-up, validation and manufacturing of a drug from early development up to commercial supplies.
- Support the development, communication, and execution of the overall CMC strategy.
- Ensure compliance with regulatory guidelines.

**Qualifications and Experience**:

- **Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required.**:

- Pharmacist or Equivalent with PhD Minimum of 10 years job relevant working experience in the pharmaceutical industry
- Minimum of 5 years of leading of an interdisciplinary drug product team
- Scientific expertise in parenteral formulations and/or formulations for combination products
- Scientific expertise in small molecule formulation development
- Proven know how of development of dosage forms to be used in combination products would be advantageous.
- Profound knowledge of GMP, quality control and pharmaceutical development and/or production processes, based on current guidelines.
- Profound knowledge in QbD, DOE and QRM
- Ability to negotiate, plan, and coordinate technical development and manufacturing activities.
- Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures, and dynamics.
- Excellent English knowledge (oral and written)

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