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Pharmaceutical development lab project manager

Swiss Biotech Association
Mendrisio, TI

Jetzt bewerben

Details zur Stelle

Festanstellung | 100%

Qualifikationen

Doktorat
Englisch
Master

Vollständige Stellenbeschreibung

Founded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica's mission is to continuously strive to improve therapies by enhancing its products' formulations and usability for the benefit of clinicians and patients.

We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer for patients and easier to perform. Every year we reliably supply millions of doses of our products across a range of therapeutic classes, including anaesthesia and analgesia, while expanding to address further healthcare needs.

To strengthen our Pharmaceutical Development team at our headquarter in Mendrisio (Switzerland), we are currently looking for a Pharmaceutical Development Laboratory Project Manager (Formulation expert).

Position summary

The Pharmaceutical Development Laboratory Project Manager will operate under the direct coordination of the Pharmaceutical Development Laboratory Manager and will manage projects related to:

Galenical development of new sterile injectable drug products and ophthalmic products.
Optimization of formulations related to sterile liquid and semi-solid drug products already in place.
Formulation development of both small and macro-molecules API.

Key responsibilities

Coordinate and execute the activities related to the assigned formulation development projects:
- Define qualitative and quantitative composition of formulations to ensure stability, compatibility, and bioavailability.
- Develop and optimize sterile injectable formulations (large and small volume parenteral, ophthalmic gels, suspensions, emulsions, lyophilized products) applying QbD principles and Design of Experiments (DoE) studies.
- Design and execute formulation trials, dissolution studies (including pilot-scale dissolutor testing), and data-driven optimization strategies.
- Evaluate extractables and leachable risk in collaboration with analytical team.
- Evaluate nitrosamines risk in collaboration with analytical team.
- Support aseptic processing or terminal sterilization strategy selection.
Support scale-up activities and technology transfer to manufacturing.
Collaborate cross-functionally with Manufacturing, Quality Assurance, Quality Control and Regulatory Affairs.
Improve galenical development and formulations selection by attending courses, seminars and meetings.

Qualifications and skills

Master’s degree or PhD in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry).
At least 10 years of post-degree work experience, including at least 5 years in Pharma R&D context.
Familiarity with both small and macro-molecules API.
Demonstrated expertise in injectable and/or ophthalmic formulation development.
Proven hands-on expertise in aseptic processing, sterilization strategies, and lyophilization cycle development.
Practical experience applying QbD principles and/or DoE in drug product development.
Strong experience with late-stage development, scale-up and commercial product support.
Familiarity with ICH/EU/US/Swiss laboratory guidelines related to the technical subjects.
Excellent command of written and spoken English.

Preference will be given to candidates based in Switzerland.

We offer

Fulltime permanent employment in a young working environment and positive culture.
Sintetica promotes diversity and gender equality.

Company

Sintetica SA

Location

Mendrisio, Switzerland

Contact information

Camilla Ferrari

[email protected]

0916404250

Jetzt bewerben

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