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. 

The role

As Senior Scientist Protein Analysis & Characterization you will be part of the functional group Manufacturing and Analytical Science and Technology (MAST), a team of 10 colleagues. 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. You will be responsible for analytical activities, both internal and external, required for the CMC development.

The role plays a key part in CMC development, performs protein characterization, develops analytical methods, and provides analytical support. It combines hands-on laboratory work with coordination of laboratory activities performed by external collaborators, such as CLOs and CROs. The work requires a structured and thorough approach, together with strong collaboration skills.

In this role, your main responsibilities include:

• Develop and qualify analytical methods for biopharmaceuticals in clinical development, including advanced characterization techniques.

• Lead and perform in-house analytical activities and manage outsourced analytical work at CMOs/CLOs.

• Provide scientific expertise in analytical method transfer, comparability and stability studies, and formulation development.

• Act as analytical expert in deviation investigations, CAPA, and change control.

• Stay up to date with relevant analytical technologies and regulatory requirements.

• Author and review analytical documentation, including method descriptions, protocols, validation, qualification, and transfer reports.

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 have a strong scientific interest combined with a goal-oriented and proactive mindset, you bring extensive experience in method development for biopharmaceuticals and protein characterization. You stay current with industry advancements and relevant regulatory guidelines and actively share your expertise with others We further believe you enjoy hands-on laboratory work, analyzing complex information, providing sound solutions and recommendations, and identifying, adapting, and implementing 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 Life Sciences.

• 10 years of experience in the pharmaceutical industry.

• Extensive experience of analytical method development, specifically HPLC methods, and characterization of biopharmaceuticals during clinical development.

• Experience of coordinating outsourcing activities involving direct contact with CMOs/CLOs, including oversight of method transfer and validation.

• Experience of industry regulatory standards.

• Excellent verbal and written communication skills in English.

It is a strong advantage if you also bring:

• Experience of MS, CE, CD, or DLS.

• Experience of forced degradation, stability, and/or comparability studies.

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

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