Cimeio Therapeutics

(Associate) Director, Analytical Development with focus on Cell- and Gene CMC

Basel, Basel City   |   Full Time

Cimeio Therapeutics is looking for a (Associate) Director, Analytical Development with focus on Cell- and Gene CMC. 


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 (Associate) Director for Analytical 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.


RESPONSIBILITIES

  • Design, develop and qualify analytical methods required for characterization of gene edited hematopoietic stem cells (HSC), including the establishment of specificity, sensitivity, linearity, precision, accuracy and range (e.g. flow cytometry, cell count, qPCR, ddPCR, ELISA, analytics of genome editing events, NGS, cell-based potency assays)
  • Establish analytical project strategy and successfully drive execution throughout CMC method development activities and as basis for clinical manufacturing
  • Author and review documents including development and method validation reports, SOPs, assay transfer protocols/reports, CMC sections of regulatory filings (IND, IMPD, BLA, etc.), and scientific journal publications
  • Interact with CMOs and other vendors as required to support method transfer and method validation activities
  • Work closely with, and support quality control on technical investigations, OOS, OOTs and release assay troubleshooting
  • Identify, qualify, and manage critical reagents according to regulatory standards
  • Use statistical analysis tools and DoE to understand method robustness to establish relevant system suitability criteria for methods


QUALIFICATIONS

  • PhD in biology, biochemistry or related discipline with 8+ years of work experience, thereof minimum 6 years of experience in the biopharmaceutical industry in CMC assay / bioanalytical development
  • Previous industry or academic experience in Cell- and Gene Therapy and/or Gene Editing research and development is preferred
  • Established track record of success supporting early and late-stage CMC and clinical product development teams
  • Cell therapy product characterization, method bridging, comparability, control strategy experience is a plus
  • Solid understanding of ICH and other industry guidelines supporting method development, qualification, validation, and transfer
  • Good knowledge of cGMP as relevant to laboratory practices and respective analytical analysis
  • Hands-on experience with several of the following analytical techniques: Flow cytometry, ELISA, qPCR, ddPCR, NGS, functional cell-based assays (e.g. in vitro killing etc.)
  • Experience with analysis of gene edited cells
  • Proven track record developing assays for the assessment of cell-based products including composition and potency employing multiple analytical methods
  • Sound statistical and DoE knowledge used in development and validation of analytical methods
  • Excellent communication skills with proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team


WHAT WE CURRENTLY OFFER

  • Offices: Our well-equipped laboratories and offices are located at the Tech Park Basel, a premier address for early-stage start-ups.
  • 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.

To apply, please send us this application form together with your CV and Cover Letter.

Job-ID:
CIM-052
 
Function:
Scientist
 

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