Manager, QC Raw Materials

Emergent Biosolutions•Canton, MA

1d•$129,000 - $156,000

About The Position

Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. The Manager of Raw Materials will lead, develop, and manage the QC Raw Materials testing program at the Emergent BioSolutions 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.

Requirements

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 productsTesting/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 analysis skills and provide appropriate CAPAs
Must have a knowledge and experience with cGMPs, 21CFR210, 211, 600, USP-NF, and Aseptic Processing Guidelines.
Must be a team player and able to align.
Ability to influence without authority and influence within a highly matrixed organization
Excellent interpersonal skills both verbal and written
Ability to work independently with little supervision from the department Director.
Knowledge of pharmaceutical GLPs and GMPs, laboratory techniques, safety precautions, and regulatory/industry guidance.

Nice To Haves

LIMS experience desired.

Responsibilities

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.