Manager Manufacturing Operations
Philadelphia , PA 19107
Posted 4 weeks ago
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Responsible for the daily operations in the manufacture of the following: Cell Banks, Viral Vectors, Cell Therapy, and Gene Therapy products following Current Good Manufacturing Practices.
Knowledge of cell culture operations and support systems is essential. Demonstrates managerial skills and a strong working knowledge of the regulatory compliance requirements for the production of biologicals used in clinical studies are essential. Demonstrates a clear understanding of the contract manufacturing business and effectively manages all Cell Banking operations to address compliance, customer and business needs in a timely manner.
Responsible for hiring, training, supervising and evaluating staff. Remains current regarding technical manufacturing requirements and develops / modifies production methods to fully address such issues. Reviews and approves, SOPs, and new client master batch records. Manages operations assuring customer satisfaction and compliance with appropriate regulatory standards including but not limited to the Code of Federal Regulations (CFR), United States Pharmacopia (USP), and/or Points to Consider (PTC).
- Determining staff and equipment resources. Identification and development of Standard Operating Procedures (SOPs), Master Batch Records, and Product Specification Sheets.
Staffing and training of the Manufacturing group to be competent in current Good Manufacturing Practices (cGMP). Interacts with Engineering, Maintenance, Validation, Quality Assurance, Quality Control, and Supply Chain groups. As needed, interaction will be required with material/equipment vendors and clients. Responsible for management of daily operations for the on-time completion of client product being manufactured.
Has a strong working knowledge of the regulatory compliance requirements for clinical and commercial production of biologics. Assists in overseeing startup and validation efforts for the Manufacturing Facility and may represent Manufacturing during Factory Acceptance Testing of new equipment. Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely and professional feedback.
Maintains production schedule to meet customer and business goals. Provides accurate production forecasting methods with continuous improvement through capacity optimization and cost reduction programs. Implements and maintains personnel policies, procedures and production control systems.
Ensures cGMP compliance, ensuring that all production equipment is properly validated and production processes meet quality standards. Work closely with all operations support functions (Quality Assurance, Quality Control, Facilities, Engineering, Validation, Project Management and Supply Chain groups) to ensure that Company objectives are met on schedule. Ensure full compliance with cGMPs and applicable health and safety regulations (OSHA) is achieved and maintained.
Working with Quality and QC team to develop and administer aseptic control programs. Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work Plans, monitors, and appraises direct reports including performance competencies, goals & job results Coaches, counsels, and conducts disciplinary actions Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required. Ability to work in a team environment and independently as required Maybe required to work holidays and weekends
- HS Diploma or equivalent required and 5+ years relevant technical experience and min 2 years Managing people BS/BA in Science related field preferred; or combination of relevant Experience & Education Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility is required. Excellent communication skills, both oral and written.
Demonstrated leadership skills. Ability to evaluate technical data and write technical documents. Ability to manage multiple manufacturing projects simultaneously. Holiday and shift work often required based on manufacturing schedule as determined by Management
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.