Associate Director, Process Development

Position Summary:

Responsible for directing and overseeing a team which develops downstream purification processes for recombinant proteins and subsequently transfers those processes to the manufacturing facility or support process characterization and associated studies. Responsibilities include process development and scale-up activities, instruments and equipment operation and troubleshooting for programs transferring into Manufacturing as well as programs remaining in Process Development. Will also be responsible for planning resource utilization to meet development and production schedules, identifying issues that may delay a project and implementing appropriate actions to keep projects on track. Must strictly manage delivery of project deliverables and milestones and be able to report progress and status to upper management. Will also contribute to operational and strategic planning activities as it relates to capacity expansion, capital planning, new business offerings and technologies and/or serve as a subject matter expert within the global network.

Position Responsibilities:

• Leads, assesses, coaches, and develops a group of scientists and associates. May lead Project and/or Group Lead(s) and assigned subordinate teams. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.
• Supports Business Development in evaluating new business opportunities, reviewing scopes of work, and advising on experimental detail. Interacts with potential new customers as technical SMEs.
• Manage and track project deliverables according to project timelines, identify and manage risks and roadblocks to project deliverables/timelines, and contribute to project timeline development.
• Oversees and/or executes the evaluation, development and implementation of new downstream technologies leading to process improvements and efficiency of operation in support of downstream process development and manufacturing activities. Identifies and drives standardization of operations to improve efficiency and best practices.
• Executes development and manufacturing requirements by meeting or exceeding productivity, quality and capacity objectives as set forth by regulatory bodies, client contracts, and management. Ensures team also adheres to these requirements.
• Supports development of strategy and objectives of Process Development to meet the organization’s strategic goals and long-term growth planning.
• Collaborates with colleagues in other regions to drive alignment and contribute to global initiatives and objectives.
• Oversees and may execute compilation of data and drafting of technical documents. Leads or oversees leadership of client presentation development, presents to clients, and serves as technical SME for functional area on team.
• Responsible for maintaining training compliance, according to site expectation. Reviews documentation and records of others.
• Designs or advises on laboratory experiments in support of downstream/drug substance process development including preparing solutions, running downstream unit operations (chromatography, tangential flow filtration, clarification, normal filtration, etc.), sampling and executing basic analysis of process samples (concentration, pH, conductivity, etc.).
• Reacts to change productively and handles other essential tasks as assigned.

Minimum Requirements:

Bachelor of Science degree in a scientific discipline with a minimum of 13+ years related experience, a Master’s degree with 9+ years related experience, or a Ph.D. in a scientific or biochemical engineering area (or equivalent) and 6+ years related experience. At least 4 years of experience serving in a relevant managerial capacity required. Must have strong knowledge of GMPs and biotechnology-derived product regulations.

Excellent written and communication skills for customer service and ability to meet strict client deadlines. Experience with cell culture aseptic technique required. Experience with bench and pilot scale cell culture bioreactors preferred (e.g. Ambr, Applikon and SUBs). Knowledge of GMPs and biotechnology-derived product regulations preferred.

Also requires a demonstrated track record in the following key areas:

• Ability to work independently

• Excellent organization and planning skills

• Skilled in data analysis, plotting, reporting, and delivering presentations

• Strong orientation for Quality and Customer Service

• Demonstrated level of respect for individuals

• Demonstrated contribution to science in appropriate area

• High level of integrity and personal responsibility

• Record of innovation and strong leadership skills

• Strong collaboration and team building skills

Salary: $152,000-$190,000