Manager, QC Raw Materials

About the role

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.

Responsibilities

• Lead, manage and professionally develop all staff members
• Accountable for testing of raw materials
• Affirms assessments of 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
• 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
• Cook up 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

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)
• Comprehensive knowledge of pharmaceutical GLPs and GMPs, laboratory techniques, safety precautions, and regulatory/industry guidance
• Knowledge of cGMPs, USP, and FDA requirements, including equipment and method validation/verification
• 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
• Possess strong root cause analysis skills and provide appropriate CAPAs
• Have a knowledge and experience with cGMPs, 21CFR210, 211, 600, USP-NF, and Aseptic Processing Guidelines
• Be a team player and able to align
• Able to influence without authority and influence within a highly matrixed organization
• Excellent interpersonal skills both verbal and written
• Able to work independently with little supervision from the department Director

Qualifications

• 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, including equipment and method validation/verification
• 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

Skills

• Knowledge of pharmaceutical GLPs and GMPs, laboratory techniques, safety precautions, and regulatory/industry guidance
• Knowledge of cGMPs, USP, and FDA requirements, including equipment and method validation/verification
• 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

Benefits

Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant’s geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent.