Senior Director, Analytical Process Development
The Senior Director of Process Development is responsible for overseeing process development and technology transfer to product manufacturing according to Food and Drug Administration (FDA) guidelines and current Good Manufacturing Practices (cGMP). The Senior Director will assist in development of departmental strategic plans and prioritize projects with an emphasis on continuous production and quality improvements. This is a performance based position where success is measured through the achievement of organizational and departmental goals.Responsibilities
- Plans and manages departmental strategy to meet organizational and departmental objectives as well as Process Development related regulatory commitments. Ensures timely delivery on key milestones.
- Oversee the development, design and scale-up processes, instruments and equipment used to perform the process development and manufacturing functions.
- Oversee and manage strategy for process design, optimization, scale-up, technology transfer and process troubleshooting to meet project timelines and company goals.
- Oversee the optimization of production of products manufacturing, assuring compliance with GMP and FDA regulations.
- Oversees analytical testing to support process development and manufacturing where appropriate.
- Oversee technology and manufacturing process transfer, providing product for applicable clinical trials as required.
- Provide leadership and direction imperative for the successful growth and operations within this Process Development. Department and relationships with internal and external development efforts. Oversee the development of efficient cell culture processes.
- Plan and manage strategy for process design, optimization, scale-up, technology transfer and process troubleshooting to meet project timelines and company goals.
- Provide scientific and technical leadership for pre-clinical projects and projects in clinical development and technical support for commercial product.
- Responsible to allocate resources and budget to ensure successful achievement of departmental goals. Provides Process Development input to organizational budget.
- Identifies, develops, and as required, validates new technologies and methods to improve Process Development and Manufacturing operations.
- Ensures that all necessary documentation is maintained. Reviews and approves departmental reports. Ensures the integrity of Process Development's contributions to regulatory submissions and due diligence documentation.
- Communicates key issues, and interfaces effectively at all levels within the organization including participation at regular senior management meetings to include pertinent input on scientific, technical and compliance issues to other groups as required.
- Represents Process Development in discussions with corporate partners in the US and overseas and with the FDA as appropriate.
- Maintains current knowledge of new technologies and innovations within the field of MAb cell culture, purification and formulation.
- Hires, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff; establishing expectations, defining roles, supporting career development and managing performance.
- Collaborates with Manufacturing and Manufacturing Technical Services to support the implementation of cost effective production procedures that will improve product quality and yield.
- Perform additional job related duties as required.
- Requires a PhD and demonstrated senior leadership experience. Alternatively, Bachelor’s degree and 12 years’ experience including senior management experience.
- Relevant experience and technical knowledge in biologics process development is required.
- Demonstration of initiative and leadership through experience.
- Demonstrated ability to interact with senior management and regulatory officials.
- Clear, concise, written and verbal communication and presentation skills.
- Ability to maintain extensive working knowledge and proficiency in applicable cGMP regulations and procedures.
- Demonstrates potential for technical proficiency, scientific creativity, productive collaboration with others, and independent thought.
- Strong organizational skills demonstrated ability to prioritize projects, and to meet deadlines with minimal supervision are required.
- Ability to manage performance and motivate personnel to work effectively and efficiently.
- Position may require travel.
- Requires ability to work extended, and at times, unusual hours, to meet business needs.
- Experience with monoclonal antibody production preferred.
- Prior experience with upstream and/or downstream process development and technology transfer for cGMP biologics manufacturing preferred.