Cmc Project Manager

Affibody is a clinical stage radiopharmaceutical company that develops next generation targeted radiotherapies designed to enable very specific tumor binding across a broad spectrum of cancer diseases. It is a science-driven company with a long-term commitment to develop novel drugs based on their innovative technology platform.

Affibody is now looking for an additional CMC Project Manager.

The role

The CMC Project Manager is part of the functional group Manufacturing and Analytical Science and Technology (MAST), a team of 10 colleagues led by Susanne Wood. The group is responsible for all CMC-related activities, including process development, development of analytical methods, non-GMP analyses, protein characterization, and production of GMP material at contract manufacturers. The group is part of the Research Operations department. As CMC Project Manager you will coordinate complex activities and drive delivery of business-critical goals within set timelines for process development, formulation, and external manufacturing. The role has end-to-end responsibility spanning a broad scope across biopharmaceutical development and navigates both cost efficiency, scientific objectives, and regulatory requirements.

Your key contributions will include:

• Lead in-house and outsourced activities across upstream, midstream, downstream development, peptide synthesis, formulation, drug product (including radiolabeling), and analytical method development.

• Provide scientific expertise in DS, DP, and formulation development of biomolecules.

• Lead cross-functional project teams and manage budgets and resources.

• Coordinate and lead outsourcing, sourcing (RFPs, contracts, QAAs), and CMO management, including technology transfer and manufacturing of DS and DP.

• Ensure compliance with applicable quality and regulatory requirements for biopharmaceutical DS and DP.

• Author, review, and maintain process descriptions, protocols, reports, regulatory documentation, SOPs, and manage deviations, CAPA, and change control.

• Plan and conduct technical and quality audits.

Why join?

Affibody offers a science-driven, innovative, and dynamic environment with high technological leadership and expertise. At Affibody you will be part of an engaged team and you will be able to contribute with your knowledge, attitude, and the synergies you make in collaborations. You will have the opportunity to grow both personally and professionally working with cutting-edge technologies and helping to advance drug candidates from the laboratory into clinical use.

Your profile

You are a driven, structured, and communicative person with a strong interest in process development, formulation, and manufacturing. You bring a broad understanding of CMC development for biologics as well as in depth knowledge in process development. You thrive in a dynamic organization, enjoy working cross-functionally, and take ownership to drive business-critical goals forward. You are proactive and curious, comfortable coaching others, and able to adjust course when priorities change. You navigate complex situations to find solutions and as needed introduce new technologies. As for a perfect cultural fit we expect you to share our core values Caring, Ambitious and Goal-oriented.

Qualifications:

• University degree in Chemistry and/or Biotechnology and/or Process Engineering and a minimum of 10 years of experience in the pharmaceutical industry.

• Extensive experience of DS- and DP process development and manufacturing, including formulation development, process characterization and technology transfers and cGMP manufacturing of biologics.

• Experience of industry regulatory standards.

• Experience of cross functional teamwork, project management, and budget work.

• Experience of coordinating and leading outsourcing activities involving direct contact with CROs and CMOs.

• Excellent verbal and written communication skills in English and ability to communicate in a business environment.

It is a strong advantage if you also bring:

• Experience of peptide synthesis.

• Knowledge of radiopharmaceuticals.

About Affibody

Affibody is a clinical stage radiopharmaceutical company developing next generation Radioligand Therapies (RLTs) designed to deliver highly selective tumor targeting across a wide range of cancers. Leveraging decades of innovation in Affibody molecule discovery and engineering, together with deep understanding of the RLT field, the company is advancing a novel pipeline focused on oncology indications with high unmet medical need. Affibody’s lead RLT candidate, ABY-271, is currently being evaluated in a first-in-human clinical study in HER2 positive metastatic breast cancer.

The Affibody platform has also demonstrated clinical value in immunology and inflammation, with multiple programs being advanced through strategic partnerships.

Affibody’s main shareholder Patricia Industries is a part of Investor AB.

Further information can be found at: www.affibody.com

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Application

Appealing? Please send in an application as soon as possible but no later than 4th of March. In this recruitment Affibody is collaborating with SallyQ. For questions please contact Ellinor Crafoord, Senior Recruitment Consultant 0793554257 ellinor.crafoord@sallyq.se