- Line manage and supervise the work of a team of Analytical Development Scientists.
- Be responsible for all aspects of analytical method transfer to the QC group in accordance with GMP requirements, including transfer management under change control and authoring/reviewing method SOPs, protocols and reports.
- Introduce novel analytical techniques to strengthen Analytical Development characterisation capabilities and to support regulatory responses.
- Represent Analytical Development at cross-functional meetings with Manufacturing, Quality Assurance (QA), Regulatory Affairs and external partners to progress projects.
- Support the analytical testing of final drug product, raw materials, in-process, and product samples following Standard Operating Procedures (SOPs).
- Provide subject matter expert input in the authoring and review of Analytical Development, Quality Control and Regulatory documentation and to assist with audits and regulatory inspections.
- Assist with the running of the Analytical Development laboratories including equipment and safety procedures.
- Provide and coordinate training of members of the Analytical Development and Quality Control teams.
- Provide regular updates of project progress to the Director Analytical Development, Chief Operations Officer and other key stakeholders.
- Provide support for change control and deviations related to operations including OOS, OOT, and lab investigations.
- Review and complete documentation in accordance with cGMP.
- BSc in a relevant biological science with several years postgraduate experience is essential.
- An MSc, PhD or proven background in biochemistry, immunology and/or virology or related science is highly desirable.
Experience and Skill Requirements:
- 5-10 years industry experience is required. Experience in a cGMP is highly desirable.
- Must have strong, proven experience in the development, qualification and validation of cell-based potency and expression ELISA assays. Additional experience in qPCR, Chromatography and protein electrophoresis is beneficial.
- Several year’s experience of managing a team is required.
- Experience working in a GMP testing environment with an understanding of regulatory requirements and trends related to analytics and product development.
- Thorough understanding of current regulatory requirements and practical experience of testing in support of cGMP operations.
- Ability to interface effectively with management and other groups or project teams.
- Computer processing literacy and experience in statistical analysis.
- Excellent verbal and written communication skills.
- Good organizational skills.
Replimune is an equal opportunity employer.
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.
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.
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