Technical Project Leader Drug Product- Parenteral

vor 4 Wochen

Basel, Schweiz ALTOGEN AG Vollzeit

**ALTOGEN** is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices.

With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.

We surround ourselves with junior to expert level consultants with strong development potential, whom we support in their professional goals.

**About the job**:
As **Technical Project Leader Drug Product** will 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

**About you**:

- 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

**What we offer**:

- A permanent contract and innovative projects
- An attractive remuneration policy
- Personalized management and continuous learning to develop your career
- Great team spirt and an integration within the "Tribe"

**Job Type**: 100%

Schedule:

- Monday to Friday

Supplemental pay types:

- Commission pay

Work Location: In person

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