ManagerTL API Manufacturing

Use Your Power for Purpose

The successful candidate will supervise colleagues who are engaged in the production of APIs for pharmaceutical or biotechnology products in compliance with good manufacturing practice (GMP) guidelines and federal state and local Environmental and Safety Regulations.

This TL may facilitate (in conjunction with other area TLs and staff) regulatory and customer audit tours and complete operational quality environmental and safety incident investigations utilizing Method 1 and Pfizer Human Performance (PHP) investigational techniques. Also responsible for providing audit responses and implementing corrective actions in accordance with due dates.

Responsible for controlling unit operating expenses. Assures the unit manufactures the forecasted volume with the appropriate resources. Schedules staffing to meet customer needs and schedule attainment within budget guidelines.

Team Leader will review batch records support release of production lots and will assist in the execution of Pre/Post Campaign Reviews. Also responsible to be actively engaged in colleague development including timely performance feedback and appraisal and other aspects of the performance management process.

The successful candidate will also act as the area Process Centric Team Lead. Key accountabilities include responsibility for key operations related initiatives including evaluation of production variances data analysis driving actions as a result of key performance metrics investigation of safety and quality deviations driving a continuous improvement mindset driving an incident and injury free culture coaching shop floor colleagues and junior level supervisors.

In conjunction with other staff and shop floor colleagues the TL will help resolve both daily and long-term manufacturing issues to support the shop floor.

What You Will Achieve

• Successful application and demonstration of principles concepts of discipline. Self-directed & proactive use of technical applications on large scope applications/ projects. Identifies/executes significant process improvements.

• Develops solutions to complex problems which require the regular use of ingenuity innovation and creativity. Ability to gather analyze and interpret relate and compare information from multiple sources and identify cause and effect relationships. Ensures solutions are consistent with organizational objectives.

• Work is performed without appreciable direction. Completed work is reviewed from a relatively long-term perspective for desired results. Exercises some latitude in determining objectives of assignment.

• Guides the successful completion of major programs and may be in a team or project leadership role. Contributes to achievement of team plant and/or global goals. Ensures that projects are completed on schedule and within budget. Erroneous decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure of additional time human resources and funds. Monitors and manages the efforts of subordinate colleagues to achieve delivery of short-term and mid-term goals. Lead and motivate others generating commitment and a shared sense of purpose. Empower others to contribute their best.

• Responsible for leading the implementation and sustainment of lean management principles (i.e. IMEx Six Sigma etc.) on the shop floor to drive toward delivery of key performance metrics programs and cultures. These principles include: visual management metrics and actions schedule visualization and variance tracking continuous improvement processes equipment reliability one best way/standard work tools process capability trending and system coaching)

• Represents the organization as the contact on projects. Leads teams of diverse make-up including cross functional departments and colleague levels. Interacts with senior internal and/or external personnel on matters often requiring coordination between organizations. Conducts briefings and participates in technical meetings for internal and external representatives concerning specific operations.

• Projects and tasks covering short-term (1-3 mo) to mid-term (3-6 mo) deliverables or milestones; Progress of work measured at milestones.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelors degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR as associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience

• Effective written and oral communication

• Microsoft Applications willingness to learn and utilize SAP QTS QPSNT

• Demonstrated ability to manage and plan budgets.

• Demonstrated problem solving and business decision making.

• Provide mentoring and training of less experienced team leaders including in the use of investigational tools such as Method 1 and PHP.

Bonus Points If You Have (Preferred Requirements)

• API manufacturing experience

• People leader experience

PHYSICAL/MENTAL REQUIREMENTS

Frequent time in both manufacturing and office environments. The manufacturing environment includes equipment with moving parts. Must be able to perform gowning requirements for entry in the manufacturing areas.

Requires lifting sitting standing walking stair climbing and roof access. Must be available to support 24/7 365 operation.

Office environment with frequent time in the manufacturing areas. Possible exposure to high noise environments solvents and pharmaceutical ingredients. Use of hearing and eye protection is required. Must be available to support 24/7 365 operation.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Role supports a 24-hour production environment. This position is primarily 1st shift (7am-3pm). However to accommodate unit and site meeting schedules some time spent on 2nd or 3rd shift is expected. Holiday coverage may be required.

Relocation assistance may be available based on business needs and/or eligibility.