The Vice President, Technical Operations will function as the Head of Chemistry, Manufacturing, and Controls (CMC) to support Lexicon’s early and late-stage manufacturing of small molecules in support of the treatment of heart failure, type 1 diabetes and neuropathic pain. This exciting role will have the opportunity to provide strategic leadership and exceptional execution and will report to a member of Lexicon’s Executive Management Committee, the Executive Vice President, Innovation and Chemical Sciences. This position will oversee and direct day-to-day CMC activities for the advancement of drug development and clinical and commercial manufacturing. The role will also oversee the Supply Chain for both clinical and future commercial biopharmaceutical assets. In addition, this position will require building and maintaining strong, transparent, collaborative relationships within Lexicon, and with our contract manufacturing organizations (CMO) and external partners.

This role will be based out of our Basking Ridge, New Jersey or The Woodlands, Texas location.

KEY RESPONSIBILITIES INCLUDE BUT WILL NOT BE LIMITED TO:

• Develop and communicate the CMC strategy, key issues and remediation activities needed throughout the project life cycle, to project teams and appropriate management levels, in partnership with our Regulatory team
• Ensure all CMC related deliverables associated with each project are completed within defined timelines and meet regulatory guidelines.
• Provide a global effective strategy to optimize manufacturing sites and CMOs throughput, efficiencies and improved batch success rates, supporting expansion and growth of future commercial campaigns.
• Driving improvement projects to increase process control, robustness and efficiencies.
• Oversee the development and maintenance of the budget for assigned program activities, including the preparation of cost estimates to ensure programs are delivered on schedule.
• Direct drug substance/product process development and supply chain operational activities for the company's small molecule programs. Work closely with external CMOs, collaborators, and/or partners to rapidly advance programs to key decision points.
• Develop the supply strategy for Sotagliflozin to meet the first 3 years of demand in collaboration with the commercial team.
• Collaborate to efficiently evaluate, select, and manage contract service providers- including process scale-up, design of validation strategies, packaging development, and technical expertise with regards to routine/non-routine development and cGMP activities.
• Enhance scientific leadership in resolving manufacturing process/product issues and accelerate sharing of best practices across the organization.
• Provide Strategic Direction for product supply and oversee the role out of such a strategy to ensure no missed doses in clinic or commercial space.
• Have superb understanding of technical and compliance aspects.
• Lead the Tech Transfer of new processes from Development into Manufacturing sites and transfer of exiting processes between sites/CMO's.
• Contribute to the generation and protection of company intellectual property.

Required Skills Required Experience

QUALIFICATIONS:

• D. (or equivalent) in Chemistry, Pharmaceutical Sciences, Chemical Engineering or closely related science.
• A minimum 15 years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
• A minimum 5 years demonstrated leadership in small molecule Drug Substance and Drug Product process development encompassing late stage, Phase 3 and commercial launch experience
• Strong expertise and understanding of global CMC regulations, processes and issues in drug development
• Leadership experience in managing diverse project activities with contract CMO facilities at different global locations
• Lead diverse, multi-cultural technical teams, advancing technical area of responsibility.
• Experience in support of regulatory submissions. Experience contributing to NDA and EMA regulatory filings.
• Demonstrated entrepreneurial thinking with dedication to delivering results in a virtual environment operating across multiple segments of the organization and time zones.
• Experience with clinical and commercial supply management, process scale-up and technology transfer, cGMPs, ICH guidelines, as well as the CMC content of global regulatory submissions

To apply, please visit the careers section of our website: https://lexpharmacareers.silkroad.com/.

For additional information about Lexicon and its programs, please visit www.lexpharma.com.

Lexicon is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.

Lexicon Pharmaceuticals, Inc. is a drug-free workplace. Candidates are required to pass a drug test, background check and verification of credentials before beginning employment.