Head CMC 100%

Job content

Founded in 2004 by a group of PhD students as a spin-off from the University of Zurich, Molecular Partners AG is a thriving and steadily growing clinical stage biotech company located in Zurich-Schlieren (Switzerland) with 160 highly qualified employees.

In order to advance modern medicine and significantly improve the management of serious diseases, we have developed and successfully established a powerful new class of potent, specific and versatile small protein therapies, called DARPin® therapeutics.

The continuous development of a broad portfolio of therapeutic product candidates in oncology and ophthalmology based on the company’s proprietary DARPin® platform allowed a successful listing of the company on the SIX Swiss Exchange (ticker: MOLN). Next to our own pipeline of drug candidates we have entered into collaborations with leading international pharmaceutical companies, including Abbvie, Amgen, Novartis, Roche and Janssen Pharmaceuticals.

The highly dedicated, multi-disciplined team at MP is committed to developing breakthrough medicines for serious diseases.

We are looking for a leader of our CMC department. In this role you will assure timely product supply to support clinical development. You will lead the decision making in manufacture and distribution of Drug Substance (DS), Drug Product (DP) and Investigational Medical Product (IMP) and support approval process by providing documentation to the relevant authorities.

This challenging and diverse position will include the following tasks and responsibilities:

• Oversee USP, DSP, Formulation & Analytical Development (incl. potency assays development), Quality Control and CMC Regulatory functions;
• Evaluate, select and review the different GMP vendors to be involved in the preparation of the final DS, DP and IMP;
• Transfer as well as adapt the production and purification processes as well as analytical methods from internal R&D laboratories to a GMP vendor;
• Supervise in-house process development, preparation of tox, engineering and GMP batch(es) at GMP vendors;
• Supervise in-house formulation development activities, compatibility studies, stability studies and further studies, as required;
• Review and approve not only specifications for the DS and DP but also manufacturing documents provided by GMP vendors as defined in MPAG SOPs;
• Compile, review and approve CMC relevant documentation generated in-house or at GMP vendors, e.g. risk assessments, reports, memos, as necessary;
• Contribute to and review the quality section of the IMPD;
• Review and approve documentation related to the IMP, such as labelling and packaging instructions, IMP manual, IMP labels;
• Provide CMC advice to internal Research teams;
• For selected programs, act as CMC Project Lead, reporting into the Core Development Team.

For this position, we are looking for a highly motivated individual bringing along:

• Master’s degree or PhD in life sciences with continuous training in GMP, CMC Regulatory aspects, Project and Business Management;
• At least 15 years of professional experience in biologics product development in pharmaceutical and biotech companies; experience in microbial manufacturing is an asset;
• Extensive knowledge of GMP and applicable regulatory guidelines as well as in-depth knowledge of all CMC functional areas;
• Experience in various clinical development stages; ideally from pre-clinical to BLA;
• Natural leader with an entrepreneurial mind-set and a hands-on attitude with the ability to see the big picture and a passion for developing people and proven proficiency of line and cross-functional management;
• Proficiency in English (verbally/in writing); every further European language is an asset.

Partnership and collaboration are at the core of our company, our research activities and our product candidates. Molecular Partners offers an international working environment and the opportunity to collaborate with outstanding individuals from numerous disciplines, who contribute to our shared goals of scientific excellence, respectful teamwork and personal aspiration.

We foster true innovation and creative thinking to advance our therapeutic product candidates and continue to be inspired by the difference we can make for our patients.

At Molecular Partners you will discover a challenging job, inspiring colleagues and a true purpose. If you are interested in working at Molecular Partners, we are looking forward to hearing from you! Please submit your detailed curriculum vitae via our career portal.

We only accept online applications.

Please note Molecular Partners AG operates a list of preferred recruitment partners. For those partners who have no valid, signed agreement in place with Molecular Partners AG, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Molecular Partners AG (including any of its subsidiaries, affiliates or related companies) are not subject to payment of any form of introduction, placement or referral fees.