Manufacturing Associate II - 2ND SHIFT

Replimune•Framingham, MA

5d•Onsite

About The Position

Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves. Join us, as we reshape the future. The Manufacturing Associate I and II 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 production facility. They 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 schedule. This position is based in our Framingham location and typically has a 4-day on-site expectation.

Requirements

Minimum of 1 year working in manufacturing positions in a cGMP environment.
Experience working in one or more functional areas (Cell Culture, Purification of Drug Substance, or aseptic filling of product).
Experience with single-use manufacturing technologies.
Strong organizational skills and attention to detail.
Excellent written and oral communication skills and strong team player
Must be experienced with Microsoft Word and Excel.

Nice To Haves

Bachelor’s degree and 1 to 3 years of related work experience in cGMP biopharma manufacturing preferred or Associate’s degree or High School Diploma and 3 to 6 years of related work experience in cGMP biopharma manufacturing.

Responsibilities

Author SOPs, batch records and deviations.
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.
Assist with setup and operation of single use technology production equipment for viral production, tangential flow filtration, chromatography, filtration and aseptic filling process steps.
Become qualified and maintain qualification to 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.
Support validation commissioning efforts for manufacturing equipment.
Assist with routine maintenance of production equipment.