Director, Small Molecule Process Development
Location: Emeryville, CA
Department: R&D Technology Development
Quality is our primary guiding principle. It is the foundation on which all functions and activities are performed. Excellence in the management of Quality is fundamental and the foremost aspect upon which the CMC team are judged by our patients, caregivers, partners, colleagues, and regulatory bodies. Our commitment is to go beyond compliance and operate effective development, operations and supply systems that result in excellent products, processes, innovations, and documentation to ensure satisfaction from all stakeholders. We are committed to providing therapeutic solutions with potential to transform the lives of and their families living with serious rare diseases. The Zogenix Pharmaceutical Operations (PharmOps) group is responsible for integrating and executing all Chemistry, Manufacturing, and Controls activities as well as operations functions such as engineering, manufacturing, Quality, analysis, supply, procurement, operational excellence, capacity management, distribution, wholesaling and logistics for all products.
We are seeking an experienced professional to lead Zogenix process chemistry activities in the development and commercialization of treatments for rare diseases. The individual will lead small molecule drug substance process chemistry development from early phases through validation and will serve as the Zogenix lead for drug substance CDMO management. The individual will work closely with internal stakeholders, contract development and manufacturing organizations, and consultants to develop and characterize robust manufacturing processes, manufacture clinical trial materials, and support regulatory submissions across the product lifecycle. The Sr. Director will communicate technical strategy and collaborate with senior management in project resourcing and prioritization. The individual must have excellent working knowledge of current regulatory requirements and must demonstrate sound scientific judgment in the creation of process strategies in accordance with ICH and health authority guidelines.
Essential Duties and responsibilities
- Lead small molecule process development and drug substance manufacturing activities and provide clear direction and communication to relevant stakeholders.
- Provide technical leadership in the development of robust, efficient, and compliant process chemistry including route selection, starting material strategy, process optimization, GMP process implementation, and process design space & control plan definition.
- Lead and/or collaborate in multiple projects and multi-site, international, cross-functional project teams to meet project, departmental, and corporate goals. Develop and manage project timelines, department resources, and budgets for all small molecule process development activities.
- Closely collaborate with Drug Product Development, Analytical Development, Quality, and Regulatory from preclinical to NDA stages.
- Serve as Zogenix point-of-contact for small molecule drug substance CDMOs from early-stage to validation. Lead steering committees at CDMOs during development phase.
- Establish and maintain strong working relationships with external CDMO partners and enhance the CDMO network to expand the capability and capacity of Zogenix development and manufacturing.
- Provide innovative solutions in investigations and troubleshooting, and resolve deviations in compliance with cGMPs and internal SOPs.
- Author technical and regulatory documentation as required, including development plans, engineering protocols, risk assessments, technical reports, change controls, and IND/IMPD/NDA/MAA Quality sections.
- Support audits and regulatory inspections.
- Lead or support (depending on product lifecycle stage) tech transfer and scale up strategy development in accordance with supply needs and project objectives.
- Establish standard operating procedures as they relate to process development and clinical manufacture.
- Ensure a high standard of compliance with quality standards in CDMO development and operations.
- Provide strategic and technical input to senior leadership to inform pipeline development and other relevant business activities.
- Maintain a culture of collaboration, employee development, and goal achievement.
- Other duties as assigned.
Core Competencies, Knowledge and Skill Requirements
- Strong knowledge of modern organic synthetic techniques and process analytical technology.
- Strong knowledge of Quality by Design principles for small molecule pharmaceutical development.
- Good knowledge of statistics, including Design of Experiments and statistical process control required. Experience in use of statistical software (JMP preferred) for process development, monitoring, and analysis.
- Good knowledge of risk management principles and techniques, including FMEA.
- In depth understanding of contemporary ICH and health authority requirements and the current areas of regulatory focus.
- Expertise in technical evaluation and management of CDMOs and other suppliers.
Communication & Interpersonal Skills
- Possesses a strategic vision which integrates the voice of the customer with the core competencies of the business to drive value creation. Must have flexibility of thought, exceptional leadership skills, and extensive experience leading initiatives to drive the growth of a business. Must be able to develop, sell, and evangelize key ideas which deliver the vision for the organization and its stakeholders.
- Flexible and adaptable in constantly changing environments. Able to lead and move organizations forward with environmental and organizational ambiguity and without clear and concrete direction.
- Possesses a bias for action and displays a sense of urgency. Must possess exemplary skills in leadership, communication, project management and budget management while maintaining extremely high quality and efficiency standards.
- Be willing and able to make sound business decisions and act on them with urgency and for the benefit of the Company.
- Possesses excellent communication skills. Willing and able to develop and nurture productive business relationships with colleagues, partners, suppliers, contractors, leaders and subordinates.
- Exemplifies excellent interpersonal skills. Demonstrably able to influence positive outcome without direct reporting authority.
- Be able to quickly and accurately evaluate internal and external operations, recommend optimal decision paths based on those evaluations and lead the organization to successful delivery of business objectives.
- Exhibits the Zogenix core values of Excellence, Courage, Compassion, and Collaboration in all interactions..
- Ph D. in Chemistry or Chemical Engineering with a minimum of 10 years of experience, or MS with 15+ years of experience.
- Extensive experience in the development of small molecule pharmaceuticals required, including project leadership and team management.
- Experience in mid- to late-stage development of an approved pharmaceutical product required.
- Experience in management of CDMOs with proven track record of effective execution of development programs and GMP manufacturing required.
- A record of contribution and innovation in small molecule pharmaceutical development programs including the resolution of process development and manufacturing challenges.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Regular US and international travel required to oversee CDMOs.
- Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)
- Ability to work on a computer for extended periods of time.
- Regularly required to sit for long periods of time, and occasionally stand and walk.
- Regularly required to use hands to operate computer and other office equipment.
- Close vision required for computer usage.
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds.