Sterile Production Supervisor (2nd shift)

Job Description

Position Description

The Formulation Laboratory and Experimentation (FLEx) Center is a new multi-modality (small molecule biologics vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway New Jersey. The Sterile Production Supervisor manages a team of technicians for daily operations that support sterile supply aseptic formulation aseptic filling and visual inspection.

This role require adherence to GMP procedures strong attention to detail in completing GMP documentation proficiency in electronic systems and participation in continuous improvement projects. Positions may also support commissioning qualification and demonstration of new equipment and technologies. Successful candidates will collaborate closely with team members and partner groups including formulators engineers Quality Safety and Facilities management to drive overall success and performance of the area and clinical pipeline.

Accountability

• First line operations supervisor with a team of individual contributor production direct reports

• Ensure that shift objectives are achieved while reliably supplying quality product at a competitive cost consistent with all applicable internal and external regulations for quality (GMP) safety etc.

• Attention to Detail: Maintain meticulous records of formulation processes including ingredient quantities equipment used and environmental conditions.

• Tactical and strategic shift management including collaboration with indirect staff

• Batch Adaptability: Quickly adapt to changes in batch procedures and production schedules demonstrating flexibility and problem-solving skills.

• Promote the behaviors and principles that drive continuous improvement

Duties

• Coordinates and supervises the daily activities of individual contributors. Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors and develops plans to meet short-term objectives.

• Identifies and resolves standard day to day quality technical and operational problems within own unit. Makes decisions guided by policies and standard operating procedures that impact the efficiency and effectiveness of own unit. Receives guidance and oversight from the Operations Director.

• Works within budgetary/financial objectives set by Director

• Compliance Responsible for creating and sustaining a culture that ensures that compliance (Safety Environment cGMP etc.) are imperatives for the business. Responsible for establishing a Right First-Time culture by reducing waste and constantly driving continuous improvement. Responsible to review and approve compliance documents as per procedures or need.

• Supply Exercise judgement and decision making to ensure quality product is reliably produced while managing cost. Responsible for Shift(s) supply performance metrics (Schedule Adherence Release on Time Customer service performance Product Lead Time etc.).

• Continuous Improvement Accountable for developing a our Company Production System (MPS) and continuous improvement culture while achieving MPS Targets and business results for the Shift(s). Develop strategic initiatives related to the manufacturing process equipment and human resources in support of long range operating plans. Report Shift(s) monthly metrics and any action plans to address gaps to Management. Identify prioritizeand champion improvement initiatives to improve process efficiency cycle time and yield reduce process variability and eliminate waste.

• People Management Responsible for creating and sustaining a highly engaged workforce through utilization of our Company Leadership Behaviors and Inclusion. Provide coaching on professional development and career paths. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation. Provide feedback and input on performance evaluations for indirect staff. Support Talent Management.

• Position may require work outside of routine hours (e.g. nights / weekends) depending on business needs.

Core Skillsets

• Aseptic experience: Experience in working in Grade A environment is required including aseptic qualification and performing environmental monitoring.

• Ability to develop and lead others.

• Ability to be flexible and understand risk.

• Collaboration: Able to communicate clearly with team and work closely with other teams to ensure on time delivery of supplies.

• Continuous improvement

• Conflict resolution

• Leadership style adaptive; high performance coaching; servant leader

• Compliance mindset to safety environmental and quality regulations

Position Qualifications:

Education Minimum Requirement: Bachelors degree in business administration Science Engineering or another technical field with a minimum of 4 years of experience or at least 7 years experience in pharmaceutical manufacturing or processing with HS diploma.

Required Experience and Skills:

• Minimum (4) years experience in a functional area such as operations Management Quality Technical Operations Technology Engineering or Maintenance.

• Minimum (2) years experience in aseptic/sterile drug product manufacturing or processing

Preferred Experience and Skills:

• Minimum (2) years direct supervisory experience.

• Demonstrated knowledge of Lean

• Demonstrated experience of interacting with site divisional or regulatory audits

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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