SixPeaks Bio is a Versant Ventures and Astra Zeneca funded biotechnology enterprise focused on advancing a portfolio of antibody-based compounds targeting obesity and associated co-morbidities. The company is a preclinical stage company with a pipeline of mAbs as well as mAb-peptide conjugates entering IND preparing studies in the next few months. Our team is passionate about science and committed to improving patient outcomes through cutting-edge research and clinical trials.
In the company’s department of Pharmaceutical Development, we are seeking an experienced (Senior) Manager, CMC QA / QC (100%). The successful candidate will have gained experience from work in a relevant area of quality assurance and quality control in the biopharmaceutical industry. She/he will be a highly motivated and enthusiastic team player with strong organizational skills, eager to deliver tailored quality assurance standards to early development projects.
This Basel based position offers a tremendous opportunity to support a fast-growing biotechnology enterprise in 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 assure compliance with GMP and high-quality levels are achieved and maintained by strong interaction with Project Management, external CDMOs and associated Interfaces
- Responsible for 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
- Write-up and review of analytical protocols and reports and establish specifications
- Draft and review of CoAs, Analytical results sheets, specifications, SOPs, GUIs, TPLs and FRMs
- Independently review scientific work in project related activities
- Support establishment of documents for IND submissions as well as responding to agency questions and review CMC sections for IND filings
- Support Management of Labelling & Packaging Activities at 3rd Party Vendors, setup of IRT systems and Clinical Trial Supply
QUALIFICATIONS
- Degree in biochemistry, pharmacy, biology, chemistry, or chemical engineering;
- Apprenticeship with 12+ years,
- B.Sc. and/or M.Sc. with 9+ years, or
- PhD with 5+ years of relevant industry experience
- At least 5 years in biopharmaceutical QA/QC, including experience in 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 and instrumentation (e.g., U(H)PLC, SEC, HIC, UV-VIS, CGE)
- Familiarity with electronic document management systems (e.g., Veeva), SOP frameworks, and training systems
- Solid knowledge of quality systems, including Change Control, CAPA, deviation management, and batch release
- Strong communication skills, cross-functional mindset, and a high level of attention to detail
- Independent, proactive, and adaptable team player excited to contribute to an agile and science-focused culture
WHAT WE CURRENTLY OFFER
- People: We are an international and diverse team with talented and passionate people.
- Creativity: We offer an innovative and creative environment.
- Development: We support the individual development of our employees.
- Fun: From time-to-time we organise cool off-site summer and winter team events.
- 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.
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.