Process Development

• Drug substance technical lead within the Process Development teams (UK and US based) that ensures appropriate process development characterization / optimization experiments are being successfully executed to plan (upstream and downstream).
• Design process development lab-based experiments to support process characterization / optimization.
• Author / review protocols, reports, risk assessments, SOPs, and batch records.
• Author / review sections of applicable regulatory filings (e.g. process characterization, process control strategy, etc.)
• Optimize and execute robust bench and pilot scale process steps including cell build, production bioreactor, and purification techniques such as filtration and chromatography.
• Collaborate with manufacturing, QA, F&E, and other process development personnel to support and improve process steps within the production process.
• Ensure effective, high-quality, timely, and appropriate documentation in laboratory notebooks.
• Manage more junior lab-based staff.

• Practices and promotes safe work habits and adheres to safety procedures and guidelines.
• Provide technical representation during internal and external audits representing the process development lab function (lab activity quality compliance, process characterization experimentation, etc.).
• Keeps up to date with current technologies and trends in biologics manufacturing operations and process development characterization.

• Master’s degree in applicable field (chemical engineering, biology, etc.) and 4 to 6 years of related work experience.

OR

• Bachelor’s degree in applicable field (chemical engineering, biology, etc.) and 6 to 8 years of related work experience.

• Hands-on experience in a biologics process development laboratory setting.
• Prior experience as a people manager.
• Demonstrated ability to work in cross-functional teams across the business.
• Strong organizational skills and attention to detail.
• Excellent written and oral communication skills and strong team player.

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.

• Perform the following established procedures including, but not limited to cell culture, normal flow filtration, tangential flow filtration, packed bed chromatography, membrane chromatography and centrifugation.
• Perform formulation development to ensure Replimune’s products are stable and simple to use.
• Produce viruses and data to support QC, development and process characterization as well as to provide purified material for investigational studies.
• Execute good documentation practices.
• Plan daily workload (e.g. the operation of equipment, cell culture, data analysis and report writing) based on experimental plans and time scales established with their supervisor.
• Recognize and inform their supervisor of issues pertaining to particular operational problems or scientific/technical issues relating to their daily workload.
• Offer suggestions for resolution of technical issues based on experience. The scientist will be expected to show creativity in resolving issues, but any amendments to experimental procedures will need to be discussed and approved with their supervisor before making changes.
• Communicate verbally and in writing within the process development group and where appropriate with additional departments within the company.
• Collaborate with external contacts to enable work to be progressed.
• Record and report data in a timely and accurate manner in accordance with departmental procedures. This will also include drafting and reviewing process characterization protocols and technical reports. 
• Present scientific data at internal project and PD meetings.

• Write/revise/review SOP’s, risk assessments and COSHH forms. 
• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance.
• Troubleshoot equipment and methods within the process development and manufacturing teams.
• Additional responsibilities/tasks may be assigned.

Education will be appropriate to specific job requirements. The following educational requirements are a minimum:

• B.A or B.S. degree in a relevant biological science.

Education, training and experience will be appropriate to a specific job description. As a guideline the following may be considered:

• 3- 5 years’ experience in a relevant work environment.
• Computer literacy (including MS Word and Excel).
• Data analysis with statistical methods.
• Ability to work well as part of a multi-disciplinary team.
• Effective communication skills.
• The scientist should be capable of receiving and correctly following work instructions.
• 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.