Manager/TL, API Manufacturing

About this role

USE YOUR POWER FOR PURPOSE This position will be supporting B76 Environmental Operations and the API Training Team – day shift. 

The successful candidate will supervise colleagues and temporary contract workers who are engaged and support 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 TL’s and staff) regulatory and customer audit tours and will 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.  They also may be expected to support Environmental operating systems and work closely with the site Environmental team to ensure continued compliance with all site and regulatory environmental compliance standards .

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 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 be a key member of the area Process Centric Team.  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.  They may also support division wide programs where appropriate, such as operator training programs and local documentation storage.

WHAT YOU WILL ACHIEVE Functional/Technical Knowledge:  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.

Problem Solving and Innovation:  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.   Discretion, Latitude, Level of Independence:  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.   Impact and Organizational Contribution:  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).

Teamwork/Influence:  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.

Time Span of Work:  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) • Education / Experience: Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience. • Language Skills: Effective written and oral communication. • Computer Skills:  Microsoft Applications, willingness to learn and utilize SAP, eQMS, QPSNT, Enablon, Cority, & DOC. • Mathematical Skills:  Demonstrated ability to manage and plan budgets. • Reasoning Ability: Demonstrated problem solving and business decision making. • Mentoring: 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 manu facturing experience. • People leader experience.

PHYS

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