We are expanding our capacity and services within the Contract Manufacturing field. If you are looking to combine your CMC specialist skills and project management skills in a customer-facing role we have just the right opportunity. We are looking for an experienced CMC specialist in the area of recombinant protein manufacturing with hands-on experience in downstream processing and knowledge of upstream processing, who can take protein projects from an R&D stage to GMP manufacturing stage for our customers and partners.

About Bioneer

Bioneer A/S is a trusted strategic partner to a broad range of biotech and pharmaceutical companies in Denmark and internationally. We create customized and innovative research and manufacturing service solutions that help companies to develop and produce recombinant proteins and to generate key pre-clinical insights into the mechanisms, efficacy, safety, and delivery of their early drug candidates.

Operating from state-of-the-art laboratories Bioneer brings expert insights, speed & quality to the Life Science industry, as a Danish government-approved Research and Technology Organization.

Our Contract Manufacturing Organization (CMO) provides small scale but high-end process development and GMP manufacturing services in the specialty protein/enzyme area. The CMO works closely together with the Recombinant Protein group in the CRO when implementing or trouble shooting new manufacturing processes.

Our Contract Research Organization (CRO) provides R&D based services within the biomedical and biotechnology field. Services include end-to-end recombinant protein solutions from feasibility to non-GMP production and early drug candidate development, characterization and formulation.

About the CMC Project Manager position

You will be working in our CMO group based in Hørsholm. The CMO group consists of 14 scientists and technicians, one QA and one QA trainee.

Being responsible for managing and executing customer projects and for securing the seamless transitioning of these projects through process development, scale-up and manufacturing in-house, you will find it naturally to work with multiple key stakeholders. You will head one or more project teams, collaborate with other specialists at Bioneer and often with customers and consultants during development of robust protein purification strategies.

We expect that you have the ability to technically supervise skilled personnel at the level needed for establishing and operating downstream and formulation processes in order to secure high quality proteins including process enzymes and early stage versions of API’s.

We furthermore expect that you are familiar with QC and can assist in the preparation of the documentation needed for approval of products or for transfer of the manufacturing processes to larger external manufacturing entities.

You and your CMC team will also participate in maintenance of equipment and supporting equipment, participate in audits, troubleshoot production and commissioning of new equipment as well as all the other tasks that may land on your desk in a medium-sized company.

About you

You have a relevant education like M.Sc. or PhD degree within e.g. biochemistry, protein chemistry or process technology.

At least 3 to 5 years of documented experience with downstream manufacturing processes. Our preferred candidate has:

• Documented experience from the CMO industry or like.
• Ability to plan, execute and report development studies.
• Good collaboration skills
• Ability to head and motivate a small group of technicians and scientists.
• Responsible, flexible, highly motivated team player with commitment, initiative and humor.

We look forward to welcoming the right candidate to an exciting job in a dynamic and growing company where you can help set the direction. We strive to make Bioneer an interesting work place and we believe we can offer exciting work challenges in an informal collaborative climate. Explore Bioneer at www.bioneer.dk

Please mail your application including CV and marked “CMC specialist” to bioneer@bioneer.dk before March 20^th 2023. If you want to learn more about the position please contact Charlotte K. Lorentzen at +4545160444