Head of CMC at Ridgeline Discovery GmbH

Basel, Basel-City, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

06 Jan, 26

Salary

0.0

Posted On

08 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CMC Strategy, Contract Management, Regulatory Strategy, GMP Compliance, Project Management, Formulation Development, Clinical Trials, Quality Assurance, Team Leadership, Communication Skills, International Experience, Problem Solving, Attention to Detail, Negotiation Skills, Risk Management, Presentation Skills

Industry

Biotechnology Research

Description

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.

Responsibilities

Develop and maintain CMC and supply strategy in line with company objectives. Oversee contract manufacturing organizations and ensure compliance with GMP and quality standards.