The Fractionation Building 5 Supervisor is responsible for implementing and supervising daily activities in Building 5 to ensure manufacturing goals and project deadlines are met by the commitment date while maintaining compliance with the current manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply. He/she is expected to drive results to support plant strategic imperatives. He/she must enforce company rules and regulations and promote Shire Values within his/her shift. He/she is expected to coach/mentor employees to drive performance. He/she must be able to prepare and present technical reports and trends. He/she must have the ability to manage multiple priorities in a manufacturing plant setting, and prioritize responsibilities of self and direct reports appropriately. He/she must have organizational and administrative skills. He/she is expected to set the example for all other employees of Shire. The direct reports of supervisors observe the behavior of their leadership and interpret that behavior as acceptable. Supervisors must promote the appropriate behavior, compliance, cleanliness, and culture of Shire. Essential Duties and Responsibilities
- Responsible for supervising production related activities in Building 5 to ensure manufacturing goals are met.
- Facilitate and verify appropriate training for all employees on the shift (including but not limited to cGMPs, job skills, safety, etc.).
- Ensure assigned projects and deliverables (i.e. corrective actions, exception reports, meeting action items, etc.) are completed per the commitment date.
- Identify, lead, and implement initiatives to drive continuous improvement in Building 5.
- Implement systems to maintain compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines, FDA, and any other regulations that apply.
- Ensure 100% compliance with established department procedures and regulations in producing high quality therapeutic products.
- Drive performance with employees by providing a positive and equitable work environment emphasizing respect, responsiveness, and results, as well as, utilizing the talent management process.
- Interface with computerized (automated) manufacturing control system.
- Be present at the shift transition with the outgoing shift supervisor(s) as well as ensure proper shift transition/communication to the next incoming shift.
- Chair the QIT 0 meeting of their respective cell(s).
- Spend a minimum of 80% of their shift on the manufacturing floor, as feasible
Education and/or experience
- Must have demonstrated interpersonal and leadership skills with the ability to interface well with personnel of all levels.
- Must be able to work and facilitate a team-oriented environment.
- Must possess problem-solving skills.
- Must have organizational and administrative skills.
- Must have strong communication skills (both verbal and written).
- Must have demonstrated ability to manage multiple priorities in a manufacturing setting and prioritize responsibilities of self and direct reports appropriately.
- Must have the ability to analyze and interpret scientific and statistical data.
- Must be able to prepare and present technical reports and trends to management.
- Must have ability to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
- Must have strong aptitude for operation and controls of manufacturing equipment and processes.
- Must have experience with Microsoft Office applications.
- May be required to supervise multiple groups.
Requires BS degree in a scientific or engineering discipline with minimum of 2-4 years related manufacturing experience. 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 walking around observing conditions in 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.
- Facial hair must be removed if required to wear respirator.
- Will work in a cold and wet environment.
- 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 filter aid 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.
- May be required to work in a Clean Room environment and under cool/hot storage conditions.
- 5% travel may be required.