Manufacturing Associate I

Replimune; Framingham (MA); On-site; USD 79,000 - 103,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Flexible time off

Year-end shutdown

Job summary

Replimune is seeking a Manufacturing Associate I/II in Framingham, MA to execute cGMP manufacturing operations for the production of Replimune products. You will collaborate across departments, support SOP generation and documentation, and help ensure manufacturing readiness.

Responsibilities include authoring batch records, maintaining aseptic methods, inventory, equipment cleaning, and qualification maintenance, with potential weekend shifts based on production needs.

Qualifications

• Bachelor's degree and 1–3 years of related work experience in cGMP biopharma manufacturing preferred.
• Associate degree or HS diploma and 3–6 years of related work experience in cGMP biopharma manufacturing.
• Minimum 1 year working in manufacturing positions in a cGMP environment.
• Experience in Cell Culture, Purification of Drug Substance, or aseptic filling.
• Experience with single-use manufacturing technologies.
• Strong organizational skills and attention to detail.
• Excellent written and oral communication skills; strong team player; Microsoft Word and Excel proficient.

Responsibilities

• Author SOPs, batch records and deviations.
• Maintain the ability to aseptically gown and/or sterile gown.
• 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.
• 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 steps.
• Become qualified and maintain qualification to perform visual inspection of final product vials.
• Follow procedures in performing processing steps and operating production equipment.
• Perform tasks in safety, quality systems, and cGMP; complete production documentation.
• Assist with the review of completed manufacturing documentation.
• Support validation commissioning efforts for manufacturing equipment.
• Assist with routine maintenance of production equipment.

Skills

cGMP manufacturing

SOP adherence

Documentation

Aseptic processing

Single-use tech

Organizational skills

Communication skills

Education

Bachelor's degree in related field

Associate degree or HS diploma with experience

Tools

Microsoft Word

Microsoft 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:

• 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 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.

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.

• 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.

Other responsibilities

• Support validation commissioning efforts for manufacturing equipment.

• Assist with routine maintenance of production equipment.

Some occasional work may be required on weekends/holidays depending on production schedule needs.

Educational 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.

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 $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 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.