For our customer, a smaller start-up Life Sciences group headquartered in the Zug area, we are seeking a VP Chemistry, Manufacturing & Controls:

Responsibilities:

• Reporting to the CEO
• Manage the entire CMC department and all its activities, including the outsourcing of R&D, formulation and analytical services, and contract manufacturing of commercial drug products (mainly relating to small molecules tablets)
• Provide leadership and support with cross-functional interactions across the entire R&D, commercial and G&A organization
• Establish, lead, coordinate and support projects for the development and manufacturing of drug products
• Ensure that CMC projects comply at all times with quality, timeline and budget; timely address and escalate issues and concerns as may be needed
• Assist in developing documents and maintaining compliance consistent with GLP and cGMP standards throughout all (pre-)clinical stages up to regulatory submissions
• Manage the implementation of the overall CMC strategy for all drug products from (early) development to commercial manufacturing
• Manage the development, transfer, automation and qualification of manufacturing processes for the group’s development and commercial products
• Manage the sourcing, management and distribution of manufacturing equipment, APIs, excipients and pharmaceutical packaging
• Manage the handling and distribution of regulated drug product supplies to internal and external partners
• Manage SOPs, IQO Protocols/Reports, BPRs and Specifications for Pharmaceutical Development and Manufacturing activities
• Analyze and summarize complex data sets, including the use of appropriate statistical tools for the identification of CPPs and CQAs, development of drug product specifications and shelf-life estimates for drug product formulations
• Develop and maintain an in-depth knowledge of drug product manufacturing and development technology; and the associated regulatory requirements
• Perform such other tasks as may be assigned from time to time

Requirements:

• MSc in chemistry, pharmaceutical sciences or related field, ideally complemented with an MBA (or similar business degree)
• Fluency in English; German, French and/or Spanish working knowledge would be a plus
• At least 12 years of industry experience with increasing responsibilities in pharmaceutical R&D and manufacturing (mainly relating to small molecules tablets)
• Extensive experience with development and optimization of manufacturing processes and oversight of manufacturing campaigns for supplies ranging from GLP toxicology supplies to cGMP Phase 3 clinical trial material
• Strong understanding of all regulatory requirements relating to pharmaceutical R&D, manufacturing and commercialisation
• Extensive experience in management of pharmaceutical process development and drug product manufacturing
• Experience with both aseptically produced and terminally sterilized drug products would be a plus
• Proven track record in leadership experience (up to executive director level)
• Excellent interpersonal verbal, written and presentation skills in communications with internal and external customers
• Highly organized, structured and efficient working style; ability to manage a high workload with conflicting priorities in a challenging environment
• High integrity and loyalty; ability to effectively manage confidential information
• Willingness to travel up to 20%