Assay Development

• Effectively partner cross-functionally in the planning, drafting, editing and reviewing of high quality technical documents to support regulatory submissions.
• Coordinate with external collaborators and CROs to manage the compilation and approval of research, developmental, analytical and pre-clinical related documents and reports.
• Work effectively with company document management system and related tools, templates and procedures in order to ensure efficient production of documents which complies with applicable regulatory requirements, SOPs, and company standards.
• Work with relevant teams to obtain accurate information and data for written materials and ensure consistency of facts and style within and across documents as feasible and appropriate, including but not limited to review of text, tables, and figures for accuracy, logic, and clarity of presentation.
• Maintain scientific knowledge of Replimune’s viral products and the parent wild type virus, analytical methods and projects and current relevant regulations.
• Drafts and develops documents, which may include but are not limited to analytical development reports, characterization reports, process development reports, product comparability, product sequencing reports, regular environmental, safety and quality reviews, manufacturing batch analysis, analytical specification reports and scientific and CMC literature searches.
• Assists with the techinal review of regulatory submissions and responses to regulatory agencies, e.g. FDA, MHRA etc.
• Perform format and/or content quality control (QC) review of technical documents produced by the development functions to ensure accuracy and consistency.

• Exceptional technical writing capability and an ability to convey and summarize complex technical data and analyses in a clear and concise manner.
• Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system.
• Working knowledge of ICH and US regulatory requirements is desired.
• Excellent interpersonal skills, abilty to develop important relationships with key stakeholders and to work both independently and collaboratively with a team in a geographically dispersed environment.
• Must thrive working in a fast-paced, innovative environment while remaining flexible proactive, resourceful and efficient. 
• Strong project management skills in guiding and working with cross-functional representatives through the composing or updating technical  documents in a timely and high-quality manner.
• Experience in successfully resolving conflicting editorial opinions expressed by team members.

• MSc or PhD in Virology, Immunology or a related field is required.

• Strong demonstratable background in virology or gene therapy, with an in-depth knowledge of Herpes Simplex Virus an advantage.
• Has at least 5 years relevant experience in biotechnological or pharmaceutical scientific writing and a history of prior meaningful participation in regulatory submissions or publications in high-impact scientific journals.
• Understanding of biotechnological analytical and process techniques is advantageous e.g. chromatography, ELISA, SDS-PAGE, cell-based assays, PCR.

Replimune is an equal opportunity employer.

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.

Replimune now requires Covid vaccination disclosure for all US employees.

• Effectively partner cross-functionally in the planning, drafting, editing and reviewing of high quality technical documents to support regulatory submissions.
• Work effectively with company document management system and related tools, templates and procedures in order to ensure efficient production of documents which complies with applicable regulatory requirements, SOPs, and company standards.
• Work with relevant teams to obtain accurate information and data for written materials and ensure consistency of facts and style within and across documents as feasible and appropriate, including but not limited to review of text, tables, and figures for accuracy, logic, and clarity of presentation.
• Maintain scientific knowledge of Replimune’s viral products and the parent wild type virus, analytical methods and projects and current relevant regulations.
• Drafts and develops documents, which may include but are not limited to analytical development reports, characterization reports, process development reports, product comparability, product sequencing reports, regular environmental, safety and quality reviews, manufacturing batch analysis, analytical specification reports and scientific and CMC literature searches.
• Assists with the technical review of regulatory submissions and responses to regulatory agencies, e.g. FDA, MHRA etc.
• Perform format and/or content quality control (QC) review of technical documents produced by the development functions to ensure accuracy and consistency.

• Exceptional technical writing capability and an ability to convey and summarize complex technical data and analyses in a clear and concise manner.
• Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system.
• Working knowledge of ICH and US regulatory requirements is required.
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders and to work both independently and collaboratively with a team in a geographically dispersed environment.
• Must thrive working in a fast-paced, innovative environment while remaining flexible proactive, resourceful and efficient. 
• Strong project management skills in guiding and working with cross-functional representatives through the composing or updating technical  documents in a timely and high-quality manner.
• Experience in successfully resolving conflicting editorial opinions expressed by team members.

• BSc in biological science or related field.
• MSc or PhD in Virology or a related field is highly desirable.

• Demonstratable background in virology or gene therapy, with an in-depth knowledge of Herpes Simplex Virus an advantage.
• Has at least 2 years relevant experience in biotechnological or pharmaceutical scientific writing and a history of prior meaningful participation in regulatory submissions.
• Understanding of biotechnological analytical and process techniques is advantageous e.g. chromatography, ELISA, SDS-PAGE, cell-based assays, PCR.
• Proven project management  and team leadership capability.

Replimune is an equal opportunity employer.

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.

Replimune now requires Covid vaccination disclosure for all US employees.

• 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.

• 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.

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.

Replimune now requires Covid vaccination disclosure for all US employees.