Drug product scientist (Temporary 12 months)

Pharmaceutical DevelopmentLausanne, Vaud, SwitzerlandTemporary

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Description

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

Here: apply.workable.com/debiopharm-group-sa/

For our Pharmaceutical Development Department based at our Headquarters in Lausanne, we are looking for a:

Drug product scientist (Temporary 12 months)

Requirements

• Lead all formulation, process and drug product development and supply aspects of projects for clinical and pre-clinical trials in coordination with the CMC and wider project teams in line with patients’ needs; define and implement Drug Product development and manufacturing strategies accordingly


• Act as the main point of contact, manage, challenge and lead activities with external partners, including supplier selection, negotiating offers and contracts


• Lead regulatory and control strategies for semi-finished products in line with Quality by Design principles, taking into consideration the status of the project, assessing technical risks, and ensuring their mitigation. Support the redaction of regulatory affairs documentation sections related to your area of expertise.


• Propose and implement innovative formulation strategies based on a deep understanding of compound developability, drug delivery, innovative processes and technology providers


• Establish and implement drug product development strategies (including Life Cycle Management)


• Integrate, in the design of technical strategies, issues related to Intellectual property and freedom to operate


• Prepare and review key documents (development reports, protocols, batch records, etc)

Your profile

• Master degree in relevant scientific discipline (pharmaceutical engineering, etc), pharmacist or equivalent


• At least 4 years industrial experience, working in hands-on formulation, drug product development roles in the pharmaceutical industry


• Proven expertise in the field of pharmaceutical product development for oral solid dosages and, ideally, injectable products as well as supporting regulatory and quality guidelines.


• Field experience in pharmaceutical product development and manufacturing at laboratory and pilot scales. Strong technical knowledge to design and manage process development and scale up studies.


• Experience in process development with Quality by Design approach


• Experience in managing contract development and manufacturing organizations (CDMOs)


• Knowledge of radiopharmaceutical or biological drug development is a plus


• Excellent knowledge of English


• Good knowledge of standard IT tools


• Ability to work as part of a team and effectively prioritise tasks


• Highly motivated dealing with project challenges and leading innovation

Benefits

• Possibility to work from home with 2 days visit in the office (Lausanne)


• The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.


• The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.

The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.

Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.

Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.

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