Career Opportunities in the Foresite Capital Network

Senior Director, API The Company:Our mission is to improve the health and quality of life for the millions of people affected by chronic respiratory diseases. We do this through the development of our first-in-class molecule, ensifentrine. Ensifentrine has the potential to provide relief for millions of patients suffering from a variety of respiratory conditions including chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF) and asthma. Our focus is driven by our desire to ensure that innovative and differentiated molecules can reach these patients.The experience of the Verona team, and its highly effective leadership allows us to challenge the status quo in drug development and commercialization. Verona provides a professional, diverse, and inclusive working environment where our employees thrive. We are driven to succeed by our desire to help those dealing with the chronic progressive nature of respiratory diseases. We offer you the opportunity to help create a new future for those people living with respiratory diseases. The Opportunity:Verona Pharma is currently recruiting a Senior Director, API to join our team, reporting to our Senior Vice President, CMC. In the role of Senior Director, API, you will be responsible for being the in-house organic chemistry subject matter expert, responsible for the development, manufacture and supply of Active Pharmaceutical Ingredients (APIs) for preclinical and clinical studies, and you will provide technical support to the ongoing commercial manufacture of the ensifentrine API, and assisting in the evaluation of potential second suppliers and the transfer of the ensifentrine commercial manufacturing process to the selected supplier.Remote working and flexibility are important parts of our culture at Verona. We are open to hiring candidates based in the US and UK. You will periodically be required to go into the Raleigh, NC office for key meetings, training, and other activities as needed.To be successful in this role, you must possess an in-depth knowledge, experience and understanding of chemical process research and development, including the development of phase-appropriate manufacturing processes for APIs and associated analytical methodologies, spanning early and late-stage development, with a commercialized process as the ultimate goal. You will also have superior leadership skills with a deep understanding of CMC and Chemical Development functions and their relation to the company’s operations as a whole.We know our employees are our most valuable asset, and our culture conveys that. Trust, accountability, and efficiency are core values that drive our working environment. We have a unique opportunity to build a company that will bring a first-in-class medication to chronic respiratory disease patients with significant unmet needs. We also offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff. Responsibilities:

• Responsible for the third-party manufacture and supply of Active Pharmaceutical Ingredients (APIs) (through third party vendors) for non-clinical and clinical studies according to agreed timelines, within the allocated budget and to agreed specifications.
• Develop strategies and operational plans for the drug substance elements of the Company's activities, ensuring the development of phase-appropriate manufacturing processes for APIs and associated analytical methodologies.
• Assess ad select appropriate Contract Development and Manufacturing Organizations (CDMOs) for API.
• Provision support across development, manufacturing, analytical and stability aspects, including detailed review of vendor reports, oversight of analytical methods development and validation.
• Create, review and/or approve development reports, protocols, batch manufacturing records, analytical test methods and reports, validation protocols and validation reports.
• Maintain a comprehensive file of API development and manufacturing reports.
• In partnership with the company’s Quality Assurance function, ensure all drug substance activities are consistent with best industry practices and to appropriate international development and commercial standards, in keeping with international regulatory guidelines, including current Good Manufacturing Practices (cGMP) and the International Conference on Harmonization (ICH), and in alignment with the company’s Quality Management System.
• In partnership with the company’s Regulatory CMC function, write and prepare the drug substance elements of regulatory documentation, such as the Module 3 section of INDs and IMPDs.
• Operate as the subject matter expert (SME) on drug substance and chemistry matters (degradation pathways etc) relating to formulated drug products that are under development and/or product(s) that are commercialized.
• Provide input into the enhancement of the company's proprietary positioning of products (new intellectual property and development of difficult to copy products).
• Partner with Management and Finance colleagues to actively manage budgets and costs relating to API/CMC.
• Other duties as assigned.

Requirements:

• Advanced degree (PhD) in chemistry or relevant subject required.
• Minimum 7-10 years’ experience of leading API development activities and projects in biotech or pharma companies, developing robust, scalable, cost effective and safe chemical processes.
• Experience managing projects with external CDMOs/CMO, across early and late stage and progression into commercial.
• Proven ability to manage, lead and motivate others, both indirectly and directly.
• Prior leadership position(s) in API/CMC management, including responsibility for delivering API for development stage projects from exploratory development through to the filing and commercialization stages.
• Demonstrated understanding of drug substance process research, development and manufacturing, including analytical (e.g. NMR, LC, GC, XRPD etc) and solid state aspects (salts, polymorphs, crystallizations, particle engineering etc).
• Competency in analytical chemistry associated with drug substance development and manufacture, including method validation.
• Working knowledge of relevant ICH, FDA and EMA guidelines.
• Results-oriented, scientifically rigorous, and uncompromising commitment to quality.
• Demonstrated problem solving and trouble-shooting capabilities.
• Self-starter mentality as well strong collaboration skills across multiple departments.
• Familiarity with line management and project management, embracing budgets and timelines.
• Excellent collaborative, analytical, communication, managerial and supervisory skills.
• Capable of building trust and influencing across all levels of the organization.
• Flexibility regarding schedule and work projects.
• Strong Microsoft Office skills (Word, Excel, PowerPoint, Project etc.).
• Ability and willingness to travel up to 30%, including inter-office, domestic and international travel.

An Equal Opportunity EmployerVerona Pharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Verona Pharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.