Manufacturing Associate I
About the role
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.
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. For more information, please visit www.replimune.com.
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.
Requirements
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.
Experience And Skill Requirement
- 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
For this role, the anticipated base pay range is $79,000-$102,500. 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