PRIMARY PURPOSE OF POSITION:
This position is responsible for managing development and subsequent manufacturing of biological processes from cell line development through upstream and downstream processing at contract manufacturing organizations. The development and manufacturing functions are performed outside the company. Management of CMOs and CROs is a critical aspect of the job and will include frequent visits to the contractors depending on the intensity of the ongoing activities. The role involves significant cross functional collaboration with other functions, including non-clinical, analytical, quality assurance and regulatory departments.
MAJOR DUTIES OF POSITION:
• Manage and support development, scale-up, production and tech transfer of processes within or between CMOs.
• Design and manage cell line development, cell bank creation and safety and stability testing
• Remove the bottlenecks and rationalize processes to optimize processes consistency, yield, and robustness.
• Ensure all experiments and activities are documented appropriately to ensure full traceability of work performed at the CMO/CRO.
• Contribute to preparation and submission of CMC portions of regulatory submissions and updates (IND, BLA, and post marketing commitments)
• Will be responsible to design and manage in-process stability studies and interpret stability data to establish in-process stability data and DS storage times and specifications.
• Will design, manage and support process characterization studies and develop control strategies for process validation.
• Support process investigations and help determine root cause of excursions during development and commercial manufacturing.
• Work effectively with team members and contractors both in-person and remotely. Provide direction, support, and corrective action as needed.
• Ensure that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.
• Have a high level of scientific curiosity and keep informed of technical developments within the industry by attending conferences and reviewing papers thus advocating a culture of continuous improvement.
KNOWLEDGE AND SKILL REQUIREMENTS:
• PhD in Biochemistry / Biology / Chemical Engineering, with 8 -10 years biological process development and manufacturing experience with a strong record of achievement; If Masters Degree, 12+ years experience.
• Proven hands-on experience with culturing cells, operating microbial fermenters and/or mammalian bioreactors as well as harvesting material using centrifugation, depth filtration and/or TFF
• Demonstrated, in-depth understanding of environmental, nutritional and mechanical factors influencing cell growth, productivity and longevity.
• Hands-on experience with purification techniques including operation of FPLC and UF/DF systems
• In depth understanding of charge and size based separation mechanisms and manipulation of operating conditions for optimal separation of target protein from process and product related impurities.
• Demonstrated experience in tech transfer of a process from development to manufacturing or between manufacturing sites.
• Working knowledge of CMC regulatory requirements for biological pharmaceutical products at various stages of development as well as practical application of principles of QbD.
• Highly flexible, works well in a team environment, and has the skills necessary to organize, communicate and influence, with an unquestionable level of integrity.
• Demonstrated proficiency in oral and written communication, an innovative problem solver and proven ability to recognize and recommend areas for improvement.
• Knowledge of quality systems and FDA/EU regulations as they relate to process / product development and manufacturing of biologics.
This section requires quantitative data that will help provide some measure of the size or scope of the position. Data should be on an annual basis.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. The individual must be able to:
• Lift and move up to 25 lbs.
• Sit, stand, kneel, stoop, walk, use hands to finger, handle, or feel, point, and reach with hands and arms.
• Use the telephone and communicate clearly with a host of external individuals, domestically and globally.
• Work at computer for extensive periods of time.
• Work in a fast paced working environment managing multiple tasks.
• May require up to 30% travel; domestic and global, at times on short notice.
WORK ENVIRONMENT and ENVIRONMENTAL CONDITIONS:
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.