Executive Director CMC/ Pharmaceutical Development

Executive Director CMC/ Pharmaceutical Development

Company is a publicly traded biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant.

All around the world, millions of people suffer from pernicious fungal diseases. At Company, we are bringing a ground-breaking class of drugs to the battle by developing innovative products that have the strength, safety and versatility to defeat even the most insidious fungal diseases. When working in the field of life-threatening infectious diseases, you are racing against rapidly evolving pathogens. Since our company's inception, we have focused on getting in front of changing fungal infections that are growing resistant to existing agents and are becoming increasingly deadly.

Today, our research continues as we explore the next-generation antifungals with potentially transformative fungicidal potency against yeasts and molds. Company is committed to positively impacting the lives of patients suffering from fungal infections, from the most common to the difficult-to-treat and deadliest.

We are seeking an experienced Executive Director, CMC to join our team. We are committed to positively impacting the lives of patients by developing innovative therapies, come join us and make a difference.

Position Summary:

Reporting into Chief Executive Officer, the selected individual will be responsible for oversight of all CMC related strategic & operational activities for drug substance and drug product from preclinical development stage through manufacturing.

· Lead CMC group including Supply chain

· Lead the drug substance and drug product process development, manufacturing, and analytical development

· Identification, selection and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture of Drug Substance (API) and formulation development and cGMP manufacture of Drug Product (DP) in support of ongoing clinical programs and commercial supply

· Development of robust, scalable manufacturing processes for drug substance and drug product formulations to support clinical studies.

· Responsible for technology transfer of drug product and drug substance manufacturing process including fermentation and downstream purification to CMO and external partners.

· Oversee Company supply chain in assuring availability of materials for clinical & non-clinical studies.

Owner of all CMC sections in global regulatory fillings.

Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations.

Lead CMC strategy and author drug substance and drug product sections for global regulatory filings for clinical trial and market authorization including IND, IMPD, NDA, and MAA.

Maintain relationships with CMO's on various activities, i.e., project management, budgeting/invoicing, etc. and oversee CMO development operations

Author study development reports, process characterization reports, transfer documents, and regulatory documents.

Represent CMC in due diligence activities.

Establish and maintain yearly CMC budgets.

Work with project teams and management to communicate status of drug substance and drug product programs.

Qualifications

• PhD in a relevant scientific discipline
• At least 15 years of experience in all stages of drug substance and drug product development, including early and late-stage clinical development and preparation for product registration.
• Experience in managing drug substance process development and manufacturing including fermentation, downstream purification and chemical synthesis.
• Expertise in oral and parenteral small molecule drug product formulation development (including IV formulations) to meet or exceed the target clinical and commercial profile. Experience in novel platform technologies desirable.
• Extensive experience in intravenous (IV) formulation development, including selection of excipients, stability optimization, and manufacturability for parenteral delivery across various clinical stages.
• Experience leading teams and proven leadership ability to align, motivate, and empower team members.
• Experience in providing strategy and authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND/IMPD, information requests, amendments, NDA / MAA etc.)
• Experience working in an environment that strives to ensure internal technical expertise in-house while driving CDMO capabilities to meet milestones for multiple projects
• Demonstrated critical thinking, problem solving, and innovation capabilities
• Effective communication, collaboration, and negotiation skills