Dir / Sr. Dir, Chemical Development

Level: Director to Senior Director

Reports To: VP, Pharmaceutical Development

Position Summary:

Works with the VP and senior management to oversee all aspects of the synthesis of Revagenix compounds intended for clinical use. Effectively identifies and communicates objectives, plans, and risks regarding research & development programs from the preclinical to late clinical phase. Represents the company’s process chemistry function externally with key stakeholders including consultants, key opinion leaders, health authorities, government partners, corporate partners / CDMOs, and investors. Effectively executes work in a largely remote work environment. Ability to travel domestically and internationally to partner sites to troubleshoot and oversee execution of work plans.

Key Attributes:

• Passionate commitment to the discovery, development, and ultimate commercialization of novel medicines to treat multi-drug resistant bacterial infections
• Driven individual with demonstrated track record of proactively seeking resources/advice as needed to advance company objectives
• Ownership mentality; effectively prioritizes success of organization above individual goals or functional areas
• Proven ability to positively impact company culture and demonstrate flexibility in fast-paced environment

Essential Functions:

• Responsible for delivering the drug substance process development and manufacturing activities for all programs
• Drug substance program management oversight, including liaising with CROs/CDMOs
• Participate in the planning of timelines, deliverables, and milestones in collaboration with other cross-functional groups
• Lead the strategy and execution of drug substance development and manufacturing including chemical process development and optimization, synthesis of impurity/active reference standards, make proposals for specifications for starting materials, intermediates and drug substances, identification of impurities, and manufacturing
• Develop and manage approaches to forecasting of multiple projects to ensure product supply on time and in location, while minimizing waste
• Lead and manage development activities for cGMP drug substance manufacturing of small molecule drugs at CMOs
• Develop target drug substance profiles and specifications, set goals and maintain timelines for CMO manufacturing activities
• Assist supply chain efforts to ensure quality, economics, and adequate supply chain security for drug substances
• Identify and facilitate purchase of custom raw materials and supplies needed for drug substance manufacturing under tight time constraints
• Interfaces with QA / QC for all CMC-related activities
• Works with senior management to develop budget and resourcing plans including external subcontracted activities and staffing (including both contract/consultant and FTE hires)
• Review proposals, support negotiation activities, recommend suppliers, verify delivery, and maintain necessary records
• Author and review technical reports, as well as regulatory related documentation (ie IND/NDA)

Essential Experience:

• Demonstrated ability to identify most efficient path to advancing/de-risking chemical manufacturing of development programs, especially transitioning from discovery to early clinical development
• Demonstrated leadership of CDMO selection and / or contracting and oversight CDMOs as governed by a detailed contract, up to and including termination of agreements for cause
• International supply chain expertise (+/- GMP raw materials, intermediates, API) either directly or through a third-party
• Experience partnering with QA and regulatory affairs to address challenges in early-stage development
• Current US work authorization and ability to travel internationally, especially for due diligence and person-in-place activities are required
• Strong synthetic organic chemistry knowledge and problem solving skills
• Strong understanding of solid-state properties of small molecules
• Direct experience with management of CMOs
• Familiarity with process validation across the lifecycle of a complex synthesis from early clinical to launch
• Demonstrated excellence in establishing a control strategy for impurities (e.g., elemental, solvents, chirality, PMI, nitrosamine, etc)
• In depth understanding and knowledge of industry practices in drug substance manufacturing and supply
• In depth knowledge of cGMP regulations and compliance
• Good understanding and knowledge of analytical methods and related issues
• Experience in writing CMC sections for Regulatory submissions
• Strong understanding of drug development process from R&D through commercialization

Education:

• Requires a Ph.D. in chemistry, pharmaceutical science, chemical engineering, or a related discipline with 15+ years of experience

Preferred Additional Skills:

• Excellent written and verbal communication skills
• Excellent decision making and organization skills
• Ability to independently prioritize key tasks
• Strong organizational/team interaction skills along with demonstrated ability to influence others