Head of CMC/CMC-QA

Vor 2 Tagen

Basel, Schweiz Granite Bio AG Vollzeit

GRANITE BIO is a recently established biotechnology company in the Ridgeline Discovery incubator located in Basel (Switzerland). Based on fundamental research over the last two decades, GRANITE BIO’s differentiated approach is to impact central disease biology nodes to transform inflammatory, autoimmune and fibrotic conditions. The lead therapeutic antibody received clinical trial approval by competent health authorities to initiate Ph1(b) trial in Q1/2024.

We are seeking a highly motivated and experienced Head CMC to join our team.

RESPONSIBILITIES

  • Select and manage CMOs for process optimization, formulation, GMP manufacture, and clinical trial supply.
  • Negotiate CDMOs Master Service Agreements and Quality-related contracts like Master Quality Agreements.
  • Develop CMC plans and collaborate with Project Teams for regulatory filing and clinical development.
  • Oversee pre-clinical and clinical supply, including timelines, budget, and risk management.
  • Provide technical leadership to ensure compliance with GMP and regulatory requirements.
  • Design and maintain quality management systems for technical development.
  • Direct overall CMC operational management, including process and analytical development, GMP production of drug substance and drug product, quality control and stability programs, material distribution and clinical trial supply for Granit’s therapeutic antibodies.
  • Ensure process and product quality through effective CMC quality systems and supplier oversight.
  • Responsible for GMP/GDP vendor qualification and auditing.
  • Establish clinical trial supply plans and support IMP release with external QP.
  • Contribute to quality dossier (IND / IMPD) preparation and review for regulatory filings.

QUALIFICATIONS

  • Master’s degree in Chemistry, Biochemistry, Biotechnology, or related field (Doctoral degree is a plus).
  • 10+ years in the pharmaceutical/biotech industry, with startup experience preferred.
  • Expertise in monoclonal antibody development and all aspects of CMC including process chemistry, drug substance/product, and formulation.
  • Extensive experience in GxP environment development/quality.
  • Strong background in QA for pre-clinical/clinical DS and DP manufacturing, and CMC QA leadership.
  • Proficient in handling Deviations, CAPAs, Change Control processes; experience with electronic quality management systems is a plus.
  • Fluent in English (written and spoken).

WHAT WE CURRENTLY OFFER

  • Offices: Our well-equipped laboratories and offices are located at the Tech Park, 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.
  • 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.

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