Manufacturing Associate II - 2ND SHIFT
Key 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.
- Absorb and 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.
- Accurately complete appropriate production documentation.
- Absorb and assist with the review of completed manufacturing documentation.
Other Responsibilities
- Support validation commissioning efforts for manufacturing equipment.
- Absorb and assist with routine maintenance of production equipment.
Qualifications
- 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.
Pay
Salary Range: $87,000 - $113,000
About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options.