Supervisor II, Manufacturing

The Senior Manufacturing Supervisor is responsible for implementing and supervising all activities in the Cell Culture production area in a commercial manufacturing setting to ensure that manufacturing goals and project deadlines are met while maintaining strict compliance with current good manufacturing practices (CGMPs), environmental health and safety (EHS) guidelines and all other regulatory requirements.
*Provide hands-on supervision of manufacturing staff in Cell Culture operations, including daily guidance, support, direction and leadership through positive interactions with all personnel during daily production operations.
*Oversee day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities - to meet customer requirements including deadlines and quality standards.
*Optimize use of raw materials, equipment and personnel in producing quality products and lead/participate in continuous improvement initiatives as part of Baxter's commitment to operational excellence.
*Interview, hire, coach, motivate, and develop staff. Set performance objectives and development plans. Monitor performance progress and conduct annual performance reviews for all direct reports.
*Author, revise and approve SOP's, batch records, deviations and other documentation as required to ensure compliance. Perform real-time review of completed Manufacturing documentation (Production Batch Records, Forms, etc.)
*May assist in developing budgets and monitoring and controlling labor and capital expenditures.
*Oversee development of and compliance with training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to CGMPs and EHS regulations.
*Resolve technical, material and CGMP problems that may impact project deadlines. Provide guidance and troubleshooting assistance as needed during a deviation in the process.
*Represent the company during FDA inspections. Provide information as necessary to FDA that establishes credibility and demonstrates compliance with CGMPs.
*Recommends manufacturing policies, procedures and programs.
*Optimize use of raw materials, equipment and personnel in producing quality products and lead/participate in continuous improvement initiatives as part of Baxter's commitment to operational excellence.

Qualification:

BS degree in a scientific or engineering discipline with 3-5 years of biomanufacturing experience or AA degree or equivalent biomanufacturing experience.

Previous supervisory experience required (4-6 years including conducting performance assessments) and strong cell culture experience in a CGMP manufacturing environment.
*Demonstrated interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment.
*In-depth process knowledge of related manufacturing equipment and processes.
*Ability to manage multiple priorities in a manufacturing plant setting.
*Ability to analyze and interpret scientific and statistical data.
*Strong professional writing skills and ability to prepare technical reports.
*Demonstrated excellent understanding of CGMPs and other regulatory guidelines applicable to the biologics manufacturing industry.
*Strong assessment and troubleshooting skills.
*Ability to respond to detailed inquiries, and present information to groups and senior management.
*May be required to supervise multiple groups/shifts.
*Overtime may be required at times.
*Solid computer skills including Word, Excel, PowerPoint

About Aerotek:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 844 895-8598 or email . However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.