Head of CMC

GRANITE BIO is a private biotechnology company located in Basel (Switzerland).
GRANITE BIO is supported by top-tier investors with ~$100M raised to date. Based on fundamental research conducted over the last two decades, GRANITE BIO’s is pursuing a differentiated approach to transform inflammatory, autoimmune, and fibrotic conditions. Both our programs are first-in-class monoclonal antibodies for large market opportunities in Immunology and Inflammation. GRT-001, the lead asset, is a CCR2-mediated monocyte depleter that has just completed a Phase 1a trial in healthy volunteers and has shown favorable safety and pharmacodynamic effect. The Phase 1b trial in patients with Ulcerative Colitis has just started. GRT-002 is an IL-3 neutralizing antibody that is thought to play an important role in type II inflammation.
Our company fosters an open, inter-disciplinary, diverse, international and creative working environment. We enable work-from-home options according to our internal workflows. The successful candidate will be highly motivated and enthusiastic with a positive “can do” attitude, attention to details and innovation, strong organizational and communication skills.

Responsibilities

• As a member of Granite’s leadership team, develop and maintain CMC and supply strategy in line with the overall development strategy to successfully meet company objectives.
• Select and manage contract manufacturing and development organizations (CDMOs) for process optimization, formulation, GMP manufacture, and clinical trial supply to build a reliable CDMO network.Act as a subject matter expert to support external GMP Manufacturing (Process set-up, Change management, Deviation impact analysis, investigations etc.).
• Serve as SME for negotiations of supply agreements and related contracts. Negotiate CDMOs Master Service Agreements and Quality-related contracts like Master Quality Agreements.
• Represent CMC and supply in clinical trial and project teams and align goals with other stakeholders.
• Compiling CMC quality documentation to support regulatory filings.
• Devise regulatory strategy for drug substance and drug product, including the development strategy for drug delivery devices.
• Responsible to set up clinical trial supply for Ph1 and Ph2 clinical trials, including multinational studies.
• Oversee pre-clinical and clinical supply, including timelines, budget, and risk management.
• Subject matter expert for regulatory and partner/customer inspections and audits or due diligence.
• Hiring, leading, and developing employees to successfully meet group objectives In alignment with Granite’s organizational growth strategy, as required.

Who You Are

• The successful candidate will ideally have a life science PhD with a strong scientific and professional background in CMC for biologicals.
• Industry experience in all CMC related activities present throughout preclinical discovery and clinical development value chain.
• Minimum 10 years of experience from significant positions in pharmaceutical/biotech industry.
• Strong background in GMP and quality related regulations and guidance
• Experience with development of formulations including development of application devices for highly concentrated biologics.
• Proven track record from CMC project management (timeline and resource planning, budgeting) as integral part of comprehensive pharmaceutical development strategies enabling fast and high-quality drug development.
• Experience in managing successfully the interfaces in early-stage clinical development, regulatory, quality, safety and clinical operations.
• The ability to conduct formal presentations to relevant stakeholders (senior management, key opinion leaders, investors, etc.) is required.
• Has worked in an international company/business environment before
• Fluency in English is mandatory.

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, Cover Letter.