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Director, Quality Control – Framingham, MA or Abingdon, UK

Replimune is a fast-paced growing innovative company that is in the process of bringing on-line a new production facility purposefully designed to manufacture our Oncolytic Immunotherapies. This multi-product facility in Framingham, MA, USA, contains cGMP manufacturing suites and Quality Control testing laboratories.  In addition, Replimune also has QC testing laboratories based in Oxford, UK.

The Director / Senior Director, Quality Control (QC) is responsible for the leadership and organization of Quality Control team across all internal and external QC testing sites for Replimune. A key role of the Director will be to ensure that the QC function is operating efficiently and able to support applications for marketing approval and commercial supply.

The QC team is responsible for activities that include:  raw materials testing, product testing, in-processing testing, stability testing and environmental monitoring testing for air, surfaces, water systems, and gas distribution systems in support of Phase III production and commercial supply.  The Director will ensure that this work is planned, performed and reported in an efficient and compliant manner. The Director will be responsible for all QC activities, focusing on areas related to batch review and product release testing to assure timely supply of product.  The Director will also be responsible for technology transfer of QC assays and validation of test procedures / sites.  Additional studies will also be required to be managed in support of regulatory submissions i.e. product stability, container closure and leachables/extractables testing.  The Director will provide technical expertise for laboratory investigations and follow through on close out actions.  The Director will be responsible for ensuring all data reports and documentation to support regulatory submissions are available on schedule.

This position is based at the Replimune Framingham facility, MA, USA.

 

Key Responsibilities:

  • Recruitment, leadership and direction of the QC team at Replimune (both UK and US based groups)
  • Management of QC activities including raw materials testing, product testing, in-process testing, stability testing, environmental monitoring and utilities supply testing.
  • Provide oversight for laboratory investigations and reports in response to OOS, invalid assays, aberrant trends / results, and manufacturing investigations.
  • Implement and maintain Quality and Compliance systems for QC group in accordance with current International GMPs and Regulatory requirements.
  • Oversees external vendors / contract testing facilities for QC testing needs and provides technical support.
  • Responsible for technology transfer of QC assays and validation of test procedures / sites.
  • Supervises creation, review and completion of data records ensuring data integrity.
  • Ensures data analysis, trending and QC specifications remain current and justified.
  • Writing and reviewing reports and regulatory documents in support of submissions to regulatory authorities.
  • Management of QC milestones and establishes objectives for and appraises QC staff.
  • Provide regular updates of QC group activities to Replimune Senior Leaders.

 

Other Responsibilities:

  • Develop and maintain a culture of continuous improvement within the QC team.
  • QC representative for cross functional meetings / projects with manufacturing, QA, Regulatory Affairs and external partners. Will represent QC during regulatory inspections.
  • Application of sound scientific and current regulatory knowledge for the planning and execution of QC projects.
  • Provide QC review and approval of policies, SOPs, validation protocols and reports.
  • Assist in the preparation of department expense, capital and headcount budget
  • Some international travel will be required.

 

Experience and Skill Requirements:

  • Minimum 10 year’s experience in a cGMP Quality environment and 5 years in a senior managerial role; or equivalent combination of education and experience.
  • Thorough understanding of current regulatory requirements and practical experience of QC testing in support of cGMP operations supporting clinical and commercial manufacturing, ideally including international experience.
  • Proven leadership in managing and motivating team members to achieve QC goals.
  • Ability to interface effectively with management and other groups, project teams and personnel at manufacturing site.
  • Computer processing literacy and experience in statistical analysis.
  • Excellent verbal and written communication skills and a track record of preparing documentation in support of regulatory submissions.

 

Educational Requirements:

B.A or B.S. degree in a relevant biological science and extended relevant commercial experience.

M.S., Ph.D. or other post-graduate degree in biochemistry or related science is preferred.



EEO & Employment Eligibility:

Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.


Recruitment/Staffing Agencies:

Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.