CMC Project Manager at Alligator Bioscience

Alligator Bioscience is a clinical stage biotech company situated in the Medicon Village science park in Lund, southern Sweden. We develop innovative antibody treatments for cancer patients. Our most advanced program, mitazalimab, is in clinical Phase II trials in Europe and our pipeline includes additional ongoing Phase I trials as well as several pre-clinical development projects.  We are currently approx. 55 employees. We believe that work can be fun and balanced, and we have a flexible mindset to accommodate this philosophy. We offer an attractive employment package in a dynamic and informal work environment rooted in an atmosphere of mutual respect, innovation, and dedication.

YOUR ROLE

The CMC group at Alligator is responsible for the development of pipeline projects from candidate drug stage through to labelled IMP ready for clinical use. As such we are positioned between the discovery and the clinical groups and have a direct influence on the development strategy of the pipeline projects. Alligator works with both monoclonal and bispecific antibodies, including our proprietary RUBY® platform. RUBY® is a unique bispecific antibody format that is gaining traction in the field, with key collaborations in the industry.

The successful candidate will become a key member in a small, dedicated, and experienced team tasked with ensuring that the projects are given the best possible chance of success from a CMC perspective. The CMC Project Manager is also a vital link between the development carried out in-house and the manufacturing of clinical trial material at selected CMO’s. 

The role is reporting to the Vice President of CMC.

 

Main responsibilities:  

  • Accountability for tracking and controlling CMC projects in terms of deliverables, timelines, and budgets

  • Point of contact for external manufacturing / testing partners

  • Setting the scope of outsourced work together with CMC SMEs

  • Be a part of the negotiation team for CMC supply agreements and proposals from CMOs

  • Represent the CMC team at cross-functional project meetings

 

OUR EXPECTATIONS

The ideal candidate has:  

  • A PhD or master’s degree in a field relevant for biotech

  • At least 5 years project management experience from the biotech / CMO industry

  • Experience of working with clinical trial material manufacturing under GMP and applicable ICH guidelines and firm grasp of the expectations from the authorities in EU and US in terms of quality

  • A strong knowledge of the CMC value chain

 

In addition, we expect the ideal candidate to be: 

  • Well-organized, detail-oriented, and efficient mindset with strong problem-solving skills

  • Flexible, quality minded with strong interpersonal skills 

  • A team player  

  • Proficient in Office 365, Teams and MS Project

  • Fluent in English (both oral and written) as the company language is English 

ADDITIONAL INFORMATION 

Alligator is a biotech company dedicated to the goal of curing cancer. Being part of a small organization offers high visibility, broad responsibilities, and an opportunity to make a real impact. You will be working with a dedicated team, there is an informal and personal atmosphere at Alligator where everybody helps one another to reach even greater achievements together. Alligator is an exciting and dynamic place to work. 

The combination of wide-ranging growth opportunities, Alligator’s unique position and the company’s core values has created a strong brand in both the academic community and the international pharmaceutical industry.

APPLICATION

We handle screening and selection on an ongoing basis and therefore encourage you to apply as soon as possible, but no later than December 18th. Please upload your CV and cover letter via the attached form. All enquiries are treated confidentially. Please note that we don´t accept applications via e-mail. 

For further information, please contact Martin Samuelsson, VP CMC, msn@alligatorbioscience.com.

We look forward to your application!