Biologist, Chemist - Process Development Cell Therapy (m/f/d)- Cimeio Therapeutics

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Cimeio Therapeutics is looking for a (Senior) Scientist, Process Development - Cell Therapy.

Cimeio Therapeutics is an applied gene editing, cellular, and immunotherapy company developing a portfolio of Shielded-Cell & Immunotherapy Pairs™ for patients with debilitating and life-threatening diseases. Cimeio’s proprietary technology platform is based on the discovery of novel protein variants, which when inserted into cells allow them to preserve function while resisting depletion by a precisely paired immunotherapy. This technology has significant therapeutic potential, which Cimeio is using to develop curative treatments for patients with genetic diseases, hematologic malignancies, and severe autoimmune disorders.

We are looking for a highly motivated (Senior) Scientist, Process Development within the CMC Development team for our Basel, Switzerland based location.

This key position offers a tremendous opportunity to support our growing company in an experienced, vibrant, and agile biotech team.

• Participate in the development and optimization of a GMP-compliant manufacturing process and control strategy for gene edited hematopoietic cell products as subject matter expert
• Design and execute experiments establishing protocols to allow consistent manufacturing and analysis of the cellular product
• Perform process characterization studies. Use engineering principles to leverage respective scale-down models
• Identify and implement relevant existing technologies and materials required for successful manufacturing of gene edited cell therapy products
• Collaborate with research, analytical development, and external partners to design, develop and implement a GMP-compliant cell therapy manufacturing process
• Lead, review and/or assist in writing and revising technical documents including laboratory SOPs, protocols and reports
• Support FMEA-based risk assessments to enable Control Strategy development
• Provide subject matter expertise during technology transfer to CMOs and provide training and on-going technical support. Support deviation investigations to ensure timely resolution and delivery of robust technical package to support GMP lot disposition
• Support writing and reviewing of process sections for regulatory filings
• PhD in biology, chemistry, or related field with 3+ years of practical experience with process development for mammalian cell lines or primary cells, preferable within the field of cell and gene therapy in the biopharmaceutical industry
• Alternatively, M.Sc. with 5+ years relevant experience
• Experience with the cultivation of human primary cells is required, preferably with hematopoietic stem cells (HSC)
• Expertise with various cell culture platforms (e.g. cell culture bags and/or G-Rex) and devices used in the manufacturing for cellular products (e.g. CliniMACS Prodigy, CliniMACS plus, Sepax, and/or Lovo, etc.) would be desirable
• Experience within a cGMP-regulated environment and knowledge of the relevant regulatory guidelines regarding process development
• Good statistical and DoE knowledge used in process development
• Working knowledge in cell biology, immunology and/or hematology is of advantage
• Ability to work independently and to participate in cross-functional teams, meet deadlines, and organize and prioritize work
• Self-organizer, keen attention to detail
• Ability to acquire knowledge quickly in the rapidly expanding adoptive gene edited cell therapy field
• Excellent communication skills with ability to communicate across a variety of audiences including team members and cross-functional project teams
• Offices: Our well-equipped laboratories and offices are located at the Technologiepark, a premier address for early-stage start-ups in Basel.
• Commuter Benefits: We support our employees tailored to their personal needs in commuting to work and offer parking facilities or a commuter contribution.
• Flexible Working: We support flexible working as appropriate.
• Christmas Closure: In addition to the 24 holidays per year, our offices/labs are closed between Christmas and New Year.
• Birthday Retreat: On top of that, your birthday is your personal holiday - our employees enjoy their birthday with a day off.
• Food: We like get-togethers during lunch time. Enjoy tasty, subsidised meals from our FELFEL food fridge.
• Coffee: Meet up with your colleagues and grab free coffee.
• Development: We support the individual development of our employees.
• German Lessons: For our international employees we support German lessons to speed up integration.
• Creativity: We offer an innovative and creative environment.
• People: We are an international and diverse team with talented and passionate people.
• Fun: From time-to-time we organise cool off-site summer and winter team events.