Manager Production

Provide centralized oversight and administration of the rFIX Purification Manufacturing Operations. The Manager is accountable for managing the activities of the staff, monitoring the maintenance of production equipment and facilities in the Manufacturing Suite, overseeing complete documentation of all required production activities and ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures(SOPs), product licenses, corporate policies and safety practices.

Manage the bulk manufacturing work unit to meet market or inventory demand for Benefix. Monitor inventories and departmental budget. Staff positions as required.

Provide technical expertise to resolve manufacturing issues.

Ensure adequate training of departmental personnel in cGMPs and SOPs. Ensure timely submission and completion of all Manufacturing Investigation Reports (MIRs) and documentation of deviations to minimize production delays.

Make certain all operations and documentation conform to cGMP standards.

Ensure that all compliance commitments are completed on time and provide documented evidence to support closure of each item according to the established timeline.

Assure that production equipment and facilities are maintained in proper working condition and in a validated mode by assuring use of Change Control procedures.

Ensure that all SOPs and batch records are maintained to reflect current manufacturing methods and are in conformance with product licenses.

Participate in facility and process inspections by domestic and international regulatory agencies.

Interact with Internal Materials Resource Planning, Quality Assurance, Regulatory Affairs, Quality Control, Maintenance, Technical Services, Engineering, Purchasing, and Safety groups and external vendors, contractors, and consultants to ensure production targets are met, and product complies with cGMP, SOPs, product licenses and corporate policies.

Maintain a safe working environment. Ensure that monthly Safety and Housekeeping Audits are conducted. Ensure that Departmental Safety Training is performed and that personnel attend Divisional Safety Meetings.Requirements:
Bachelor's degree in Biology, Chemistry or related field with a minimum of 6 years relevant experience or a Master's degree in Biology or Chemistry with a minimum of 4 years relevant experience.
3 - 5 years of experience as a line supervisor/area supervisor in a bioprocessing manufacturing environment.
Knowledge of cGMPs, other regulatory requirements and aseptic processing is required.
Strong communication and interpersonal skills are essential.
Computer knowledge is a plus.Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.For more information, visit our website at