Manager Cell Culture Manufacturing Sciences

Primary Duties: The individual is expected to provide leadership and management to one of the cell culture floor support groups within Manufacturing Sciences and Operations Support (MSOS). The key support services, deliverables, and capabilities within this group include: * Process monitoring, troubleshooting, * Exception investigation and product impact assessment * Technical training of manufacturing staff * Regulatory inspection support * Participation in PD and CMC teams, process technology transfer * Process Improvement and Optimization * Authorship of certain CMC sections of regulatory filing The Manager partners with Manufacturing, Quality, FETS, and Process Development to provide clinical and commercial product support of upstream manufacturing at the internal sites, to transfer upstream processes to internal GMP manufacturing sites. The primary objective is to ensure manufacturing processes are capable, compliant, in control, and continuously improved. Responsibilities: 65% - Manage staff through direct supervision and in terms of project coordination, technical guidance and resource allocation. * Motivate and support the career development and technical expertise of reports, and communicate company policies/goals/strategies/business results. * Anticipate resource requirements, delegate appropriately, and assure reports are productive and work is focused. * Work closely with Site Leadership Team to meet functional and company goals. * Effectively communicate ideas, project goals, and results. * Foster teamwork and drive project/process improvements. * Engages in proactive measure to promote and foster a positive safety culture to ensure zero incidents, injuries, and the protection of people, property and the environment through communications, review of EHS performance metrics and incident reports. 35% - Lead or participate in root cause investigations of complex process failure/deviations, and support the implementation of CAPAs or Change Controls. Provide assessments of technical impact to process and/or drug substance. Provide recommendations and implement continuous process improvements to increase production yields, improve process reliability, and reduce cost of goods. Participate in Process Development teams and/or CMC teams to provide manufacturing's perspective and ensure the developed process can be transferred to the GMP facilities. Participate in technology transfers, including equipment and facility fit evaluations authoring and/or review of new batch records, SOPs and regulatory submissions. Education and Experience Requirements: * B.S. / M.S. /Ph.D or equivalent in biology or engineering field. Advanced degree is desirable. * 12 (BS)/8 (MS)/4 (Ph.D.) years experience in biotech product development, manufacturing operations. cGMP experience a must. Hands-on experience with large-scale manufacturing processes, preferably with commercial products. A detailed knowledge of major unit operations associated with upstream manufacturing operations including seed train expansion, bioreactor, UF/DF, chromatography, filtration, fluid transfer, and CIP/SIP processes. A working familiarity with single-use process systems, automation (local and distributed control systems), and sterile/aseptic processing in a cGMP environment. Experience with troubleshooting / problem solving and risk assessment/mitigation. Demonstrated experience using science based approaches in problem solving and decision making under un-certainty. Experience with process/technology transfers. Key Skills, Abilities, and Competencies: * Ability to coordinate and prioritize multiple projects in a fast-paced, deadline-driven environment. * Ability to work effectively and collaboratively in a team environment * Strong written and verbal communication skills * Ability to analyze and present information logically * Fundamental knowledge of ICH, FDA, and EU guidelines relevant to CMC aspects of product development Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
Shire is an Equal Opportunity and Affirmative Action Employer