Supervisor, Quality Control Microbiology Laboratories

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Position Summary

The Supervisor, QC Microbiology Labs, is responsible for microbiology laboratory quality control of pharmaceutical manufacturing for West Chester products, the establishment of New Product Introduction (NPI's), the analysis of raw materials, utilities sampling and testing, and microbiology laboratory support for investigations within West Chester Quality Control.

As a member of QC leadership, the Supervisor will also be responsible for delivering QC and site Quality priorities and initiatives as appropriate, collaborating with manufacturing, supply chain and planning teams to deliver the site priorities.

Job Responsibilities

Ensures that systems and processes owned by their team are in a state of control and are effectively managed and maintained.

Assigns responsibilities to ensure that workload is managed within their team, ensuring effective use of resources.

Assigns and manages roles and responsibilities within their team to ensure clear accountabilities and high-level performance, that meet or exceed customer needs.

Allocates team staffing and manages the utilization of resources to ensure that departmental objectives are met within budget guidelines.

Maintains a safe work environment by ensuring that team personnel follow site EHS policies and procedures.

Develop and maintain a high performing team of Senior Microbiologists, Microbiology Analysts, and Microbiology Technicians.

Coordinates workflow within their QC team. Directs priorities and testing schedules for staff.

Utilizes Lean concepts to drive improvements.

Train others on procedures and / or processes.

Review, verify, and approve QC data while monitoring for trends and abnormalities. May author technical trend reports.

May serve as QC lead for investigations involving PET process areas related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling and testing.

Support transfer, development and qualification of new methods and processes.

Identifies and implements learning and development programs for team members.

Ensures that team skills, knowledge, and experience are appropriate and well balanced to meet team needs.

Provides feedback to their team, and to other teams that interact with team, to assist with building improved performance.

Answer compliance and process questions from others, including regulatory agencies.

Communicate policies and procedures to employees.

Lead process improvement activities and teams to meet strategic goals including Lean labs and High Performing Labs.

Communicate priorities and progress to team on a continuing basis.

Ensure that employees have the tools needed to perform their jobs safely.

Monitor training of employees to ensure compliance.

Facilitates and leads initiatives using new technologies, new policies, or new procedures to improve QC functions.

May perform testing of high complexity methods

Serves as the primary link between production and QC teams.

Other duties that support Operations, or Laboratory processes may be assigned.

Off-shift support may be required to support the site 24 / 7 Operations

Minimum Qualifications

Experience in production or quality control environment.

Strong communication and leadership skills.

Strong understanding of technical areas related to lab operations (including utilities, in-process testing, and finished product testing, along with associated equipment).

Ability to analyze and solve complex problems in a cross-functional team environment.

Demonstrated ability to work with, manage and develop people in a complex, changing environment.

Preferred Qualifications

Bachelor's degree in a Science subject (Microbiology, or closely related subject)

QC Microbiology laboratory experience.

Experience leading a team.

Experience working in a LEAN manufacturing environment and working knowledge of lean leadership principals (including 5S, Value Stream Mapping, Identify and Eliminating Waste, GEMBA walks).

Working knowledge of LIMS / Labware, MODA, Veeva, Microsoft applications, SAP-PM and / or Maximo.

Experience in sterile pharmaceutical microbiology lab testing including validation, technology transfer, change control

Demonstrated ability of successful Project management

This position may also include the following conditions :

This role requires sedentary and non-sedentary tasks. May include but not limited to standing, walking, sitting, and repetitive motion.

All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $75,000.00 - $116,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.