Process Development (Operations) Senior Associate
Replimune is a fast-paced growing innovative company that is in the process of bringing on-line a brand-new production facility purposefully designed to manufacture our Oncolytic Immunotherapies. This multi-product facility in Framingham contains cGMP manufacturing for both drug substance and drug product, as well as process development laboratory space.
Summary of job description:
Working in collaboration with colleagues within process development, the Senior Associate will assist with performing lab-based process characterization and optimization experiments in support of commercialization. This individual will have an opportunity to work across all steps within the drug substance production process (upstream and downstream). In addition, there will be opportunities to participate within important projects within the drug product process as they arise.
- Work with the Process Development teams (UK and US based) to characterize and define the critical parameters of the process steps (upstream and/or downstream).
- Author protocols, reports, risk assessments, SOPs, and batch records
- Assist with authoring sections of applicable regulatory filings
- 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 the global Process Development team in efforts to acquire product and process knowledge of the platform process and transfer this knowledge to the new labs at the Framingham facility.
- Plan and manage key elements in the start-up / commissioning of the process development lab at the Framingham facility.
- Collaborate with manufacturing, QA, F&E, and other process development personnel to support and improve process steps within the production process.
- Drive continuous improvement in our cGMP process steps through technological innovation and application of experimental findings.
- Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding.
- Ensure effective, high-quality, timely and appropriate documentation in laboratory notebooks.
- Generate PD material in the lab for development use as needed
- Additional duties and responsibilities as required.
- Practices and promotes safe work habits and adheres to safety procedures and guidelines
- Provide technical representation during internal and external audits
- Keeps up to date with current technologies and trends in drug substance processing
- Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance.
- Some travel may be required, both in country and international.
- Bachelor’s / Master’s degree in chemical engineering, chemistry, biochemistry, or a related field with 1 to 4-year(s) experience in industry is preferred
Experience and skill requirement:
- Hands-on experience in a laboratory setting
- Experience in the biotech or pharmaceutical Industry, preferably in process development / manufacturing science and technology role
- Experience conducting process characterization experiments with minimal supervision.
- 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
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.
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