Manager, QC Raw Materials

Manager, QC Raw Materials

Location:

Canton, MA, US, 02021 Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

JOB SUMMARY

The Manager of Raw Materials will lead, develop, and manage the QC Raw Materials testing program at the Emergent Bio Solutions Canton site. This role will develop and maintain all documentation with regards to testing requirements and strategies and serve as a subject matter expert (SME) for raw material issues, providing technical expertise aligned with current GMPs and current industry practice.

This position will be responsible for the site's raw materials program with an eye on continuous improvement and elimination of non-value-added monitoring. Knowledge and experience with USP methods and the ability to apply updates as required as well as maintaining compliance to USP, ICH and FDA guidance documents. A strong leader who will mentor and coach staff and be willing to work outside the box with Receiving and Manufacturing.

This position will ensure compliance to data integrity and all quality systems including writing of deviations, CAPAs, Change Controls, Effectiveness Checks, and lab investigations. This position will provide the necessary training and mentoring to direct reports, and create opportunities for staff development.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Lead, manage and professionally develop all staff members Accountable for testing of raw materials. Assesses compendial changes; leads change for revision of existing assays and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.

Assures that the Raw Material laboratory operations are appropriately staffed and trained/cross-trained to meet both internal and external compliance (cGMP) requirements. Accountable for managing the raw materials testing program to ensure quality, product specifications and adherence to all current GMPs, USP, ICH and FDA guidance documents, local procedures and Emergent Global standards. This includes conducting equipment and method Validation/Verification as appropriate Ensure the Raw Materials laboratories remains current with all changes to applicable compendia and ability to implement changes in a timely manner.

Review and approve technical and validation/verification protocols and reports. Create, review, and approve out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, Change Controls, and Effectiveness Checks as needed. Manage relevant quality control activities and prioritize work to ensure site and project timelines are met. Interface with other departments and sites regarding special projects and quality issues. Coordinate and supervise collection of testing, trending, and data reported in the Quality Management Review and Annual Product Review as appropriate.

Liaise with Regulatory Affairs and prepare/review documentation required for regulatory submissions and change controls as appropriate.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.

Bachelor's or Advanced degree in Biology, Biochemistry, or closely related scientific discipline. At least 2 years prior supervisory experience or demonstrated leadership role (e.g., Sr Analyst SME or Specialist). Knowledge of Raw Materials Testing program is required. Comprehensive knowledge of pharmaceutical GLPs and GMPs, laboratory techniques, safety precautions, and regulatory/industry guidance. Knowledge of cGMPs, USP, and FDA requirements is required, including equipment and method validation/verification Knowledge executing phase appropriate method qualifications and validations.

Knowledge in assay method validation, equipment validation, and analytical investigation for biotherapeutic and vaccine products

Testing/Managing according to compendial requirements Quality Systems experience required. LIMS experience desired. Must be able to critically evaluate data summaries and conclusions. Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required Must be able to relate raw material excursions to Manufacturing & Facility functions and provide resolution Must possess strong root cause…