Senior Manufacturing Associate - 2ND SHIFT

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.
• Accurately complete 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.

Qualifications

• 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.

Pay

Salary Range: Replimune 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 is $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.

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.

Equal Opportunity Employer

We are an Equal Opportunity Employer.