Qualified Person

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. We imagine a world where cancer is a curable disease.

 At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold and Innovative.

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, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to  contribute to the meaningful work we do which could impact the lives of patients .

Join us, as we reshape the future.

Job Summary:

The Qualified Person (QP) must fulfil duties in compliance with Eudralex Volume 4, Annex 16, Certification by a Qualified Person and Batch Release.

The QP is responsible for ensuring that each individual batch of product has been manufactured and checked in compliance with laws in force in the UK or EU Member State where certification takes place, as applicable, in accordance with the requirements of Good Manufacturing Practice (GMP) and in compliance with the relevant marketing authorisation or clinical trial authorisation and product specification file, including clinical trial protocol, for a given product and associated trial.

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

Responsibilities

• The QP must personally ensure that the following operational responsibilities are fulfilled prior to certification of a batch for release to market or for export in the EU and UK:

The sources and specifications of the starting materials and packaging materials are in compliance with the applicable regulatory application

The active pharmaceutical ingredient is manufactured and distributed according to GMP

The active pharmaceutical ingredient has been imported as appropriate

The excipients have been manufactured in accordance with requirements

The TSE status of materials used are consistent with those described in the application

All records are complete and endorsed by appropriate All required in-process controls and checks have been made.

All manufacturing and testing processes remain in the validated state.

Personnel are trained and qualified as appropriate

The finished product quality control test data complies with the specification in the applicable regulatory application

Any post-marketing commitments relating to manufacturing or testing have been addressed. Ongoing stability data continues to support certification

The impact of any change to manufacturing or testing has been evaluated, and any additional checks/tests are complete

All batch-specific investigations have been completed to a sufficient level to support certification

Any ongoing complaints, investigations, or recalls do not negate the conditions for certification of each batch

The required technical agreements are in place

The self-inspection programme is active and current

The appropriate arrangements for distribution and shipment are in place

Where appropriate, safety features have been affixed

Other Responsibilities:

• Certification of the finished product batch signifying that the batch is in compliance with GMP and the requirements of its marketing authorisation or clinical trial authorisation and product specification file.
• Confirmation that the batch has been manufactured and checked in accordance with the requirements of its marketing authorisation product specification file as applicable and the principles and guidelines of GMP.

Take a lead role in any quality defects as referred to in Chapter 8 of Eudralex, Volume 4, Part I (Complaints and Product Recall) and Part IV (Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products)

Oversee batch review of Replimune clinical and commercial products for use in the EU and UK.

Execute batch disposition of Replimune clinical and commercial products for release in the EU and UK.

Assess applicable deviations, quality defects, change controls, complaints, product labels, as appropriate.

Provide support to the company and its staff to drive continual

Qualifications

Education:

B.A or B.S. degree in an appropriate scientific M.S., Ph.D. or other post¬ graduate degree is encouraged.

Required Experience:

• Eligible as Qualified Person satisfying the provisions of Article 49 of 2001/83/EC 06 November 2001.
• Maintain up to date regulatory and industry knowledge through program of Continuous Professional Development.
  
  

Experience and Skill Requirements:

• Knowledge of EU and UK regulations and guidelines regarding GMPs.
• Sufficient industry experience no less than two (2) years of experience within relevant pharmaceutical fields.
• Experience with steriles required and Advanced Therapy Medicinal Products (ATMP) preferred.
  
  

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.