SixPeaks Bio is a Versant Ventures and AstraZeneca funded biotechnology enterprise focused on advancing a portfolio of antibody-based compounds targeting obesity and associated co-morbidities. The company is a preclinical stage entity with a pipeline of mAbs and mAb-peptide conjugates entering IND-enabling studies in the coming months. Our team is passionate about science and committed to improving patient outcomes through cutting-edge research and clinical trials.
We are seeking an experienced (Senior) Manager, CMC QA / QC (100%) in our Pharmaceutical Development department. The ideal candidate will have relevant experience in quality assurance and quality control within the biopharmaceutical industry. They should be a motivated, enthusiastic team player with strong organizational skills, eager to implement tailored quality assurance standards for early development projects.
This Basel-based position offers a tremendous opportunity to support a fast-growing biotech company within an experienced, vibrant, and agile team.
RESPONSIBILITIES
* Support the implementation and maintenance of a comprehensive Quality Management System (QMS) aligned with GMP regulations and industry standards.
* Develop and enforce quality policies, procedures, and guidelines to ensure consistency across all CMC functions.
* Lead and coordinate QA/QC activities and resources to meet project timelines and quality objectives.
* Provide expert guidance and consultancy to QA and line functions to ensure GMP compliance and high-quality standards, collaborating closely with Project Management, external CDMOs, and other interfaces.
* Manage a project portfolio of up to 4 small projects (typically up to phase 2).
* Review, interpret, and document analytical data (e.g., method development, release, stability, validation) and ensure the accuracy of QC-related documents (e.g., CoAs, specifications, risk assessments).
* Represent QC in technical project and CMC team meetings.
* Draft and review analytical protocols and reports, and establish specifications.
* Draft and review CoAs, analytical result sheets, specifications, SOPs, GUIs, TPLs, and FRMs.
* Independently review scientific work related to projects.
* Support document preparation for IND submissions and respond to agency questions, reviewing CMC sections for IND filings.
* Assist in managing labelling and packaging activities at third-party vendors, setup of IRT systems, and clinical trial supply management.
QUALIFICATIONS
* Degree in biochemistry, pharmacy, biology, chemistry, or chemical engineering.
* Relevant industry experience: Apprenticeship with 12+ years, B.Sc. and/or M.Sc. with 9+ years, or PhD with 5+ years.
* At least 5 years of experience in biopharmaceutical QA/QC, including leadership roles.
* Proficient in GMP standards and regulatory expectations for biologics (antibodies, peptides, conjugates).
* Strong experience with electronic document management systems (e.g., Veeva), SOPs, and training systems.
* Hands-on experience with analytical techniques (e.g., U(H)PLC, SEC, HIC, UV-VIS, CGE).
* Solid knowledge of quality systems, including Change Control, CAPA, deviation management, and batch release.
* Excellent communication skills, cross-functional mindset, and attention to detail.
* Independent, proactive, and adaptable team player, eager to contribute to an agile, science-focused culture.
WHAT WE CURRENTLY OFFER
* People: A diverse, international team of talented and passionate individuals.
* Creativity: An innovative and creative working environment.
* Development: Support for individual growth and development.
* Fun: Occasional off-site summer and winter team events.
* Offices: Well-equipped laboratories and offices located at the Tech Park in Basel.
* Commuter Benefits: Support tailored to personal commuting needs, including parking or contributions.
* Flexible Working: Support for flexible working arrangements.
* Christmas Closure: Offices and labs closed between Christmas and New Year.
* Birthday Holiday: An additional day off on your birthday.
* Food and Coffee: Subsidized meals and free coffee to enjoy with colleagues.
Would you like to play a pivotal role in developing innovative therapies that could revolutionize the treatment of obesity and cardiometabolic conditions?
To apply, please submit your completed application form along with your CV, cover letter, and reference letters.
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