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.
Experience and Skill 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.
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.
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.