Principal Associate I, Plant Quality Assurance - 2ND SHIFT

About the Company

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 patients’ 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. With a deep sense of purpose, a strong and evolving culture, and a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact the lives of patients, caregivers, and themselves.

About the Role

The Principal Associate I/II, Plant Quality Assurance (PQA) reports to the Associate Director, Quality Assurance and is responsible for ongoing Quality oversight to ensure real-time quality oversight for Drug Substance, Drug Product, and all other production and QC testing activities according to current good manufacturing practices (cGMP), good documentation practices (GDP), and other applicable regulations. This position proactively supports cGMP compliance and interacts with all departments within the company, particularly production staff and cross-functional groups.

This is a 2nd shift opportunity with a 4-day (Mon–Thurs) 10-hour shift schedule, based in our Framingham location with a typical 4-day on-site expectation.

Responsibilities

• Serve as the second shift QA lead, working alongside manufacturing teams to ensure current and best practices are implemented, consistently maintaining compliance with cGMP standards and keeping the plant in compliance with corporate and regulatory quality requirements.
• Perform Quality walkthroughs and inspections on the floor to maintain an inspection-ready environment.
• Review and approve executed production batch records, logbooks, and QC assays.
• Drive closure/completion (including review and approval) of cGMP documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records, and validation documentation.
• Author, review, and approve quality documents such as standard operating procedures (SOPs), user requirements, risk assessments, training materials, engineering documents, automation documents, commissioning test protocols/reports, environmental qualification protocols/reports, and validation protocols/reports.
• Conduct training on procedures, standard work, safety, and cGMP-related topics.
• Support internal and external audits and inspections as needed.
• Assist with the implementation and continuous improvement of the Quality System.
• Perform other duties as assigned.

Requirements

• BA or BS in a Science or related field or equivalent experience in the Quality function.
• 5-7+ years of experience in the pharmaceutical field, including 5 years of Quality or Manufacturing experience.
• Experience managing multiple, competing priorities in a fast-paced environment.
• Demonstrated proficiency in written and verbal communication skills (including technical writing and presentations).
• Previous Quality Assurance oversight experience.

Pay

The anticipated base pay range for this role is $120,000–$155,000. The exact base pay offered will depend on various factors, including the selected candidate’s qualifications, skills, and experience, as well as organizational needs. Base pay is only one part of the total compensation package, which also includes:

• Annual performance incentive bonus.
• New hire equity and ongoing performance-based equity.

Benefits

• Medical, dental, and vision insurance.
• 401k match.
• Flexible time off.
• Paid holidays, including year-end shutdown.

Schedule

4-day workweek (Monday–Thursday), 10-hour shifts (2nd shift).

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 designed to maximize immunogenic cell death and induce a systemic anti-tumor immune response. The platform is intended to have dual local and systemic activity, combining direct virus-mediated tumor killing with the release of tumor-derived antigens and alteration of the tumor microenvironment to ignite a strong, durable systemic response. RPx product candidates are expected to be synergistic with most established and experimental cancer treatments, enabling development alone or in combination with other therapies. For more information, visit www.replimune.com.