Summary of job description:The Senior Manufacturing Associate is responsible for executing the cGMP manufacturing operations to support the production of Replimune products at the Framingham, MA, facility. This individual will collaborate with multiple departments to support the manufacturing technology transfer and startup of the production facility and will assist with the generation/revision of Standard Operating Procedures and associated documentation to ensure manufacturing readiness.
This is a 2nd shift opportunity, 4-day (Mon - Thurs) 10-hour shift scheduleThis position is based in our Framingham location and typically has a 4-day on-site expectation.
Key responsibilities:- Author SOPs, batch records, deviations and change controls.
- Maintain the ability to aseptically gown and/or sterile gown as needed.
- Perform stocking and inventory of manufacturing supplies.
- Perform cleaning of process equipment and manufacturing suites.
- Ensure training requirements are kept up to date in operations being performed.
- Assemble, clean and autoclave process components and equipment.
- Prepare buffers and solutions following approved processes.
- Perform aseptic operations within Biosafety cabinets and clean room environment.
- Setup and operate single use technology production equipment for viral production, tangential flow filtration, chromatography, filtration and aseptic filling process steps.
- Become qualified and perform visual inspection of final product vials.
- Follow verbal and written procedures in performing processing steps and operating production equipment.
- Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements and accurately completes appropriate production documentation.
- Assist with the review of completed manufacturing documentation.
- Perform as Subject Matter Expert or system owner for specific pieces of equipment.
Other responsibilities:- Provide training to and review safety procedures with junior employees.
- Assist with establishing manufacturing training program.
- Support validation commissioning efforts for manufacturing equipment.
- Plan production activities within assigned area.
- Assist with routine maintenance of production equipment.
- May potentially work some weekends/holidays pending production.
Educational requirements:- Bachelor's degree and 3 to 6 years of related work experience in cGMP biopharma manufacturing preferred or
- Associate's degree or High School Diploma and 5 to 8 years of related work experience in cGMP biopharma manufacturing.
Experience and skill requirement:- Minimum of 3 years working in positions in cGMP environment.
- Experience working in two or more functional areas (Cell Culture, Purification of Drug Substance, or aseptic filling of Product).
- Experience with single-use manufacturing technologies.
- 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
- Ability to lift up to 50 pounds and stand for up to 3 hours at a time is required.
- Must be experienced with Microsoft Word and Excel.
Salary RangeReplimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range $95,000 -$122,500. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate's unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.
At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.
