Small Molecules CMC Expert

Galderma, the world’s largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com

In accordance with CMC Development vision and strategy, within this role you will leverage your cross functional scientific/technical understanding of CMC development (Small Molecule (Oral and Topical) Drug Substance and Drug Product) and sound knowledge of global regulatory guidelines to proactively drive and coordinate projects’ cross functional CMC content, in close collaboration with individual CMC Development functions/experts, CMC Lead and internal/external partners.

Scope: from early stage (i.e. candidate selection) to approval of the drug product and beyond with maintenance of legacy products (end to end).

• Reporting to the Head of CMC Drug Development, you will be responsible for providing CMC expertise in the definition and implementation of global CMC strategy in support of product portfolio execution
• Take into account current and evolving requirements and guidelines to ensure that the content of CMC work packages and documentation are phase appropriate
• Ensure a balanced approach to CMC development risk, understanding the impact to the business and enabling smooth approval of regulatory submissions
• Identify proactively critical CMC development issues, escalade them in a timely fashion, contribute to set and implement strategies for their resolution
• Review CMC and quality documents as needed (i.e. IND, IMPD, CTD, NDA, BLA, MAA…)
• Ensure monthly reporting of the assigned projects portfolio
• Work closely with CMC Regulatory Affairs and ensure alignment regarding questions and strategies, driving development of science-based argumentation to obtain buy-in of regulatory agencies, together with appropriate Heads of Function and SMEs
• Attend CMC meetings with Health Authorities (e.g. FDA, PMDA, EMA) as needed with the Head of CMC Drug Development
• Monitor, assess and proactively contribute to implement regional regulatory requirements and guidelines that impact pharmaceutical development activities
• Maintain current awareness of regulations, guidance documents, advisory committees, industry standards, scientific literature and trends that are applicable to current and future Rx Development
• Lead working groups to develop internal policy or guideline
• Contribute to the budget preparation of the Department

As other activity, you may also:

• Contribute on purpose to due diligence, scientific assessment of external opportunities and divesting projects
• Support strategy for patent submission and/or defense in close cooperation with the Industrial Property Team and Head of Functions

• Minimum 10 years of pharmaceutical industry experience, with at least 7 years working in CMC Department supporting worldwide Small Molecule Drug Substance and Drug Product development (Oral and Topical) with a significant experience in CMC project development and management
• Pharmacist, PhD, MS in Chemistry, Analytical Chemistry, Biotechnology, Pharmaceutical Sciences or closely related to the field
• Demonstrated understanding of pharmaceutical development, including Quality by Design methodology
• Demonstrated experience in developing and implementing CMC work plans to support phase appropriate activities, including management of timelines and budget
• Strong experience in authoring/reviewing regulatory documents (e.g. IND/IMPD, CTD, NDA/MAA) and in supporting registration process
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported data
• In-depth knowledge in developing and implementing risk management
• Experience in medical device development
• Effective project management, interpersonal skills
• Excellent verbal and written communication (English)
• Ability to solve complex problems and to propose innovative solutions
• Demonstrated knowledge of cGMP, ISO13485, 21CFR820 requirements