Supervisor II, Manufacturing

At Baxalta, we share a common set of values and behaviors that represent what we stand for and how we work together to achieve our promise to patients.

This position is responsible for implementing and supervising daily activities in B8 Manufacturing to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (GMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply. May monitor and control labor. Project scope requires an in depth knowledge of pharmaceutical manufacturing, particularly in the purification of plasma derived products. Experience in the purification of Albumin and human derived Factor VIII would be beneficial.

• Supervise the daily manufacturing operations in B8 Manufacturing – maintain (audit, refine, improve) equipment and processes within this area.
• Provide a positive and equitable working environment emphasizing the Baxalta Shared Values – Respect, Responsiveness and Results.
• Support and Emphasize the Safety and Quality commitments of the department – make decisions concerning these commitments within the area.
• Identify/prioritize/provide resources in an area to assist the superintendent to meet the annual operational plan and budgetary commitments,
• Facilitate and verify appropriate training for employees in the area (including but not limited to GMP, job skills, safety)
• Ensure compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements as required.
• Interview, hire, coach, develop and discipline staff. Assist in setting performance objectives and development plans. Monitor performance against goals and conduct annual performance reviews for all direct reports.
• Submit and/or maintain and distribute reports related to attendance, labor, efficiency, safety, scrap and others as needed.
• Ability to utilize resources and raw materials in the most efficient and productive manner possible.
• Provide leadership to assess and provide guidance and risk assessments regarding requirements for the design of the manufacturing and pilot plant facilities.
• Create Manufacturing Standard Operating Procedures.
• May supervise more than one group.
• Experience in pharmaceutical manufacturing, specifically Plasma fractionation and purification and design, installation and commissioning for projects.
• Experience implementing Lean Manufacturing concepts.
• Expertise in Batch Processing.
• Experience in CIP and scheduling of Process Operations would be a plus
• Successful track record of managing wide-ranging activities within the business unit.
• Demonstrates leadership skills.
• Recognized as a technical expert by peers and other personnel within the business unit.
• Extensive cross-functional team experience, including technical and non-technical work.
• Ability to organize and present technical and project mgt. overviews without assistance.
• Demonstrated interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment.
• Interact with all levels of personnel to analyze and solve problems related to manufacturing, Quality, documentation, and personnel issues.)
• Ability to manage multiple priorities in a manufacturing plant setting.
• Ability to understand GMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
• Strong assessment and troubleshooting skills.
• Good computer skills.
• Collect and analyze data and information to determine paths for process improvement and potential root cause/corrective actions in the case of exceptions.
• Ability to respond to detailed inquiries, and present information to groups and senior management.

• BS degree in a scientific or engineering discipline with 3-5 years of manufacturing experience or AA degree or equivalent manufacturing experience. Plus 4-6 years supervisory related experience required.
• BS degree in a scientific or engineering discipline with 3-5 years of manufacturing experience or AA degree or equivalent manufacturing experience. Plus 4-6 years supervisory related experience required.

Physical demands:

• Must be able to lift, push, pull and carry up to 50 lbs.
• In general, the position requires a combination of sedentary work and physical activity operating equipment and traveling throughout the facility.
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the work environment.
• Will work in a cold, wet environment with climbing to access platforms and/or equipment.
• Will be working in a loud area that requires hearing protection and other protective equipment to be worn.
• Will work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.
• May be required to work or be assigned to a different shift as needed.
• May be required to work in a confined area.
• Inside working conditions.
• Some Clean Room and cool/hot storage conditions.