- 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.
- Bachelor’s degree in applicable field (chemical engineering, biology, etc.) and 6 to 8 years of related work experience.
Experience and Skill Requirements:
- 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.
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.
Replimune now requires Covid vaccination disclosure for all US employees.