SEARCH CAREER OPPORTUNITIES

GENERAL SUMMARY OF POSITION:

The Deputy Director of Process Development is responsible to oversee 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.

MAJOR RESPONSIBILITIES:

• Develops departmental strategy to meet organizational and departmental objectives as well as Process Development related regulatory commitments. Ensures timely delivery on key milestones.
• Oversees the development and scale up of efficient cell culture processes and media development.
• Oversees Process Development operations at MassBiologics South Coast facility.
• Organizes and oversees strategy for purification process development for monoclonal antibodies
• Directs monoclonal antibody formulation projects
• Oversees analytical testing to support process development and manufacturing where appropriate.
• Responsible to allocate resources within budget to ensure successful achievement of departmental goals.
• Provides Process Development input to organizational budget.
• Oversees the transfer of new methods from Process Development to Manufacturing.
• 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 extensive 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.

REQUIRED QUALIFICATIONS:

• Requires a PhD and demonstrated senior leadership experience.
• Alternatively, Bachelor’s degree and 15 years’ experience, including senior management experience.
• Relevant experience and technical knowledge in biologics process development is required. Experience with monoclonal antibody production preferred.
• Prior experience with upstream and/or downstream process development and technology transfer for cGMP biologics manufacturing preferred.
• Demonstration of initiative and leadership through past 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.

*LI-AT1