CMC project manager for protein development and manufacturing

To help us expanding our services within recombinant protein development and manufacturing, Bioneer A/S is seeking a skilled CMC Project Manager to join our CDMO unit. If you want to combine your project man- agement and protein specialist skills, we have the right opportunity for you. We are looking for a technically skilled candidate, preferably with hands-on experience in up- or downstream processing who can lead pro- tein projects from an R&D stage to 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 Den- mark 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 Danish and international Life Sci- ence industry.

 

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

 

Our Contract Research Organization (CRO) provides R&D based services within the biomedical and bio- technology 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 position

As CMC Project manager, you will join our growing CDMO department of approx. 15 employees located in Hørsholm.

 

Your responsibilities will among others comprise

 

  • leading one or more cross-functional teams and secure professional and timely execution of customer projects
  • securing appropriate communication with clients
  • securing adequate tech transfer processes
  • contribute to the developments of robust and scalable manufacturing processes for the production of high-quality
  • preparing cGMP manufacturing documentation, handling deviations, change requests, and CAPAs
  • in collaboration with our QA department, contributing to further developments of our Quality Management System
  • participating in maintenance and commissioning of equipment, participate in audits, and troubleshoot manufacturing
  • supervising a team of skilled technicians

 

As part of the job, you will be instrumental for the planning of a new mammalian cGMP manufacturing unit.

 

About you

You have a relevant life science education at M.Sc. or Ph.D. level within protein chemistry or process tech- nology and preferably have at least 3 to 5 years of experience from relevant life science industry. You are a responsible, flexible, and highly motivated team player with commitment, initiative, and a sense of humor.

 

Our preferred candidate has:

 

  • Experience from a manufacturing
  • Documented experience in protein production, preferably with experience in upstream technologies including both mammalian and microbial manufacturing
  • Documented ability to design, develop and qualify robust protein purification process including rele- vant control and release
  • Experience with Quality by Design and preparation of cGMP manufacturing documentation
  • A quality mindset
  • Ability to lead, plan, execute, and report projects
  • Excellent collaboration, communication, and writing skills and are adept at leading and motivating technicians and fellow

 

Why Join Bioneer

We offer an exciting job in a dynamic and growing company where you can help further developing our CDMO unit. We strive to make Bioneer an interesting workplace and can offer exciting work challenges and development opportunities in an informal and collaborative climate. Explore more about Bioneer at  www.bioneer.dk

 

Application

Please send your application marked ‘CMC Project Manager’ by email to bioneer@bioneer.dk no later than 30-Aug-2024. Applications will be evaluated on an ongoing basis, so we encourage you to apply as soon as possible.

 

For further information, please contact: Jens Chr. Norrild, Ph.D., Chief CDMO Officer (CCO) at  jcn@bioneer.dk; +45 3045 1063.

 

We look forward to welcoming the right candidate to our team