Senior Associate, Mech Pkg, Labeling & Serialization

Replimune; Framingham (MA); On-site; USD 104,000 - 134,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Paid holidays

Job summary

Replimune is seeking a Senior Associate, Mechanical Packaging, Labeling & Serialization to join the Framingham team. You will support serialization of RPx products, assist in planning, execution, and completion of serialization processes, and provide technical leadership for packaging and labeling equipment while ensuring GMP and safety compliance.

The role is based in Framingham with a 5‑day on‑site expectation and offers competitive base pay with bonus and equity opportunities, plus

Qualifications

• Experience with vendor management and problem solving.
• Ability to work independently with minimal direction.
• Ability to lift up to 35 lbs and stand for long periods.
• Experience with hazardous materials handling.

Responsibilities

• Serve as the subject matter expert (SME) for serialization packaging and shipping line, by supporting business system testing and validation activities.
• Provide packaging engineering, equipment and component expertise to improve costs, efficiencies and meet production targets with regards to serialization activities.
• Partners with internal stakeholders to implement various DSCAA and country specific requirements.
• Develops and implements training metrics and manages the development and implementation of process improvements and technology upgrades.
• Analyze operations, workflows and packaging processes to provide solutions to maximize efficiency and reduce waste.
• Prepare presentations and technical reports.
• Practice safe work habits and adhere to safety procedures and guidelines.
• Document production activities in electronic systems, batch records, logbooks, or forms.
• Follow operational procedures and instructions from the manager/lead.
• Other duties as assigned that are relevant to the position.

Skills

Vendor management

Problem solving

Independent work

Lifting 35 lbs

Stand long hours

Identify deviations

Training records

Hazardous materials

High-value products

Computer systems

Education

Biotech Certificate

Associates Degree

Engineering Bachelor’s Degree

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.

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 Associate, Mechanical Packaging, Labeling & Serialization will be a part of a cohesive team responsible for the serialization of RPx products at Replimune’s Framingham facility. The Senior Associate, Mechanical Packaging, Labeling & Serialization will support the Supply Chain team in the planning, preparation, execution and completion of various serialization processes in accordance with SOP’s, Good Manufacturing Practices and Safety policies/procedures. This role will also provide technical improvements, processes, materials, systems, troubleshooting support and project leadership for the packaging, labeling equipment associated with packaging serialization. The Senior Associate, Mechanical Packaging, Labeling & Serialization will support day‑to‑day operations.

This position is based in our Framingham location and typically has a 5-day on‑site expectation.

Key responsibilities:

• Serves as the subject matter expert (SME) for serialization packaging and shipping line
• by supporting business system testing and validation activities
• Provides packaging engineering, equipment and component expertise to improve costs,
• efficiencies and meets production targets with regards to serialization activities
• Partners with internal stakeholders to implement various DSCAA and country specific
• requirements
• Develops and implements training metrics
• Manages the development and implementation of process improvements and technology
• upgrades that help with minimizing costs and production issues
• Analysis of operations, workflows and packaging process to provide solutions to
• maximize efficiency and reduce waste
• Knowledge sharing with manufacturing groups to incorporate ideas and resolutions for
• end‑to‑end execution
• Prepare presentations and technical reports
• Practice safe work habits and adheres to safety procedures and guidelines
• Complete activities in strict accordance with Standard Operating Procedures
• Document production activities in electronic systems, batch records, logbooks, or forms.
• Follow operational procedures and both written and verbal instructions from the
• manager/lead.

Other responsibilities:

• Other duties as assigned

Educational requirements:

• 2 to 4+ years of cGMP experience/ Biotech Certificate/ Associates Degree or biotech /
• engineering bachelor’s degree and 0 -2 years of experience.
• Demonstrated basic math skills and communication skills.

Experience and skill requirement:

• Experience with vendor management
• Problem solving skills – anticipates and resolves complex problems
• Ability to work independently and with minimal direction
• Ability to lift to 35 lbs. and move heavy objects.
• Ability to stand for greater than 3 hours.
• Identify and communicate process deviations to the manager.
• Keep all training up to date and retrain prior to the expiration date.
• Work with hazardous materials (e.g., Isopropyl Alcohol).
• Routinely and safely handle high-value products in various stages of packaging
• completion.
• Use computer-based systems for timecards, e-mail, and inventory management.
• Other duties as assigned that are deemed relevant to the position.
• Ability to work in teams.

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 $103,500-$133,500. 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.