Manager, QC Raw Materials

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

JOB SUMMARY 

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.

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.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    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.

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. 

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.