Senior Manufacturing Associate - 2ND SHIFT

Replimune; Framingham (MA); On-site; USD 95,000 - 122,500; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k match

Paid holidays including year-end

Year-end shutdown

Job summary

Replimune is seeking a Senior Manufacturing Associate to execute cGMP manufacturing operations at the Framingham, MA facility, supporting tech transfer and startup activities and helping generate SOPs and related documentation.

This is a 2nd shift, 4-day Mon–Thu, 10-hour schedule with on-site expectation; the role requires collaboration across disciplines, rigorous adherence to quality systems, and the ability to operate single-use production equipment.

Qualifications

• Minimum of 3 years working in cGMP environment.
• Experience in two or more functional areas (Cell Culture, Purification, or aseptic filling).
• Experience with single-use manufacturing technologies.

Responsibilities

• Author SOPs, batch records, deviations and change controls.
• Maintain ability to aseptically gown and sterile gown as needed.
• Stocking and inventory of manufacturing supplies.
• Clean of process equipment and manufacturing suites.
• Ensure training requirements are up to date in operations.
• Assemble, clean and autoclave process components and equipment.
• Prepare buffers and solutions following approved processes.
• Perform aseptic operations within biosafety cabinets and clean rooms.
• Setup and operate single-use production equipment for viral production and filtration steps.
• Qualified to perform visual inspection of final product vials.
• Follow procedures and document production steps accurately.
• Review completed manufacturing documentation.
• Act as SME or system owner for specific equipment.

Skills

Cross-functional collaboration

Attention to detail

Clear written & verbal communication

Team player

Education

Bachelor’s degree in related field

Associate’s or high school with 5–8 years experience

Tools

Single-use manufacturing technologies

Microsoft Word & Excel

Job description

Overview

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

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.

Overview

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.

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 schedule

This 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 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 $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.

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. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.