You manage drug product development projects, ensuring that scientific strategies are implemented while collaborating with teams and maintaining compliance with industry standards.
Anforderungen
- •Postgraduate degree preferred
- •Minimum 3 years relevant experience
- •Experience in product development
- •Expertise in scale-up and process development
- •Ability to manage complex activities
- •Cross-functional collaboration skills
- •Ability to contribute to effective teams
- •Fluency in English
- •Experience in pharmaceutical industry
- •Experience in project work
- •Language skills in German
Deine Aufgaben
- •Provide scientific expertise in drug product development.
- •Set project objectives and implement strategies.
- •Manage development projects and oversee contractors.
- •Collaborate with team members to meet project goals.
- •Implement laboratory work for new product development.
- •Produce clinical trial samples following guidelines.
- •Determine technical specifications for new products.
- •Assist in developing and validating manufacturing processes.
- •Create technical documentation and manufacturing protocols.
- •Transfer drug products to third-party manufacturing sites.
- •Participate in technical production support as needed.
- •Ensure compliance with registration and GMP standards.
- •Regularly update stakeholders on project progress and issues.
Original Beschreibung
# Pharmaceutical Development Manager (Limited Contract)
**EMEA, CH, Kanton Zurich, Opfikon, CSL Vifor** | **Full time**
We are currently looking for a Pharmaceutical Development Manager to join our team in Zurich on a temporary basis (6-months contract as of August). You will be ensuring the development of line extensions and new drug product development with third party companies, according to management objectives and plans. Focus will be on leading late-stage process development, analytical studies, and tech transfer in CDMO settings, managing regulatory variations and technical problem-solving, e.g. as part of deviations. In this position you will be directly reporting to the Head of Pharmaceutical Development.
**Key Tasks**
* Provides scientific expertise in drug product development.
* Contributes to setting of project objectives and implements scientific and technical strategy
* Management of development projects; cooperation with and control of commissioned companies
* Works together with and provide expertise to other team members in order to achieve specified project objectives within defined time parameters
* Ensure the implementation of laboratory work necessary for the development of new products, dosage forms and processes
* Production of clinical trial samples according to the guidelines
* Determination of technical specifications of new products
* Cooperation in the development and validation of industrial manufacturing
* Ensure the creation of the technical documentation and manufacturing protocols required for registration
* Transfer of drug products to or between third party manufacturing sites
* Participation in technical production support, if necessary
* Ensure that the quality of the work carried out complies with the valid requirements for the registration of products and with current GMP standards
* Regular information of stakeholders and supervisors concerning the progress of the projects and the occurring problems
**Your Profile**
**Minimum Requirements**
* Postgraduate degree (preferably MSc or PhD) and / or experience in relevant discipline
* Minimum of 3 years' relevant industry experience and / or equivalent experience in a relevant academic environment.
* Experience in product development, production and quality assurance
* Expertise in scale-up, process development, and CDMO oversight
* Able to manage complex non-routine activities for small-molecule products
* Cross-functional collaboration skills
* Demonstrated ability to work within and contribute to highly effective teams.
* Fluency in English
**Preferred Requirement**
* Experience working within the pharmaceutical industry with a background in late stage development and/or production for sterile and non-sterile dosage forms
* Experience in project work and excellent analytical skills.
* Language skills in German