Manager, Quality Control Analytical

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Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

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Position Summary:

The Manager, Quality ControlAnalytical will report to the Director, Quality Control Analytical team at the Resilience Philadelphia site. This motivated and organized individual with strong people skills will provide supervision and technical expertise to the QC Analytical laboratory while maintaining open communication channels to meet the needs of the organization.

She/he will work closely with the QC leadership team, Operation scheduler(s) and Manufacturing team to schedule testing and assure adherence to the QC Analytical schedule. She/he will be responsible for timely execution, review and approval of results for in process, bulk, final product, and stability samples.

The Manager, Quality ControlAnalytical will ensure that the QC Analytical laboratory is operating as expected; She/he will partner with Facilities to coordinate QC Analytical equipment and instrument maintenance and calibration. She/he will ensure the laboratory housekeeping activities are completed to maintain the QC Analytical laboratory in a state of compliance.

This role may provide occasional technical and supervisory oversight on weekends and off-hour, supporting QC Analysts working during shift.

Position Responsibilities:

• Lead, manage and develop QC Analysts team members.

• Schedule and coordinate laboratory activities to support in-process, bulk, final product and stability testing to meet established Turn-Around-Time.

• Assist in understanding and/or solve technical problems related to QC issues. Lead complex investigations for QC related issues, in conjunction with QC investigator.

• Author, review and/or approve Deviations, CAPA and Change Controls, as assigned by QC Director.

• Participate in generation, review and approvals of method qualification/validation protocols, executed protocols and reports in collaboration with Analytical Development; Author and/or review and approve QC Test Methods, SOPs, Work Instructions and all other documentation required in accordance with quality requirements.

• Identify and drive operational excellence and continuous improvement opportunities within the Resilience Philadelphia site. Contribute to Global initiatives with the Resilience network.

• Understand the requirements, expectations and needs of internal and external customers and interact in courteous, professional, supportive, and collaborative manner.

Minimum Qualifications:

• Work experience in a cGMP environment

• Prior supervisory experience

• Experience authoring and/or reviewing Deviation, CAPA and/or Change Control

• Demonstrated ability to take ownership, initiative, and self-accountability

• Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting

• Attention to detail and quick learning/application of concepts and information

Preferred Qualifications:

• BS or MS degree in Biology, Biochemistry, Molecular Biology or relevant fields

• Experience with method qualification and/or vlaidation

• Flow cytometry, qPCR/ddPCR, potency and/or ELISA assay experience preferred

This position may also include the following conditions:

• Visual Acuity

• 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.

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.