Job Description

Enara Bio's purpose is to shine a light on unconventional T cell targets to develop cancer immunotherapies designed to provide lasting benefit for broad patient populations. Our proprietary EDAPT platform enables us to discover a novel and differentiated class of cancer-specific targets from the genomic dark matter, which we call Dark Antigens. We are pioneering approaches to exploit these Dark Antigen targets with a range of immunotherapeutic modalities, including bispecific T-cell engagers, adoptive cell therapies and cancer vaccines.


Enara Bio was founded in 2016 and has been well funded to invest in the build out and growth of our R&D efforts and our fantastic team. The company is based in Oxford, UK.

Role Overview

Enara Bio is expanding its CMC footprint within the organisation to deliver a pipeline of novel, Dark Antigen-targeting bispecific T cell engager molecules to patients with cancer. We are now looking for a dynamic and experienced CMC Project Manager to support the team on all aspects of development and manufacturing of our lead product(s).


The role is multifaceted, working closely with the internal team on cross-functional projects such as the Asset Team (including representatives from Preclinical, Clinical, Regulatory, CMC and Quality), as well as ensuring close collaboration with our external consultants and CRO / CDMO partners. In this role you will be the face of the company to a variety of stakeholders and partners.

Key Responsibilities

The primary focus of the CMC Project Manager is to provide project management support to CMC projects through their initiation, planning, execution, monitoring and closure, while ensuring ongoing alignment with company strategy and goals.


Key responsibilities of the CMC Project Manager include, but are not limited to:


Ensuring that key stakeholders are identified and effective communication plans are implemented Collaborating with key stakeholders, both internal and external, to develop and implement comprehensive project plans for complex and high priority CMC activities for our lead product(s), ensuring plans reflect current priorities Preparing, maintaining and communicating changes in timelines and goals through appropriate dashboards Proactively identifying and monitoring risks and opportunities and working with stakeholders to ensure effective mitigation strategies are implemented Documenting and driving follow-up of key actions arising from project team meetings and other meetings across the company as required Driving the development and operational input into Master Service Agreements (MSAs) and Work Orders (WOs) / Scope of Work (SOW) for activities performed by CROs / CDMOs Driving the review of technical and quality documents for internal use and for the CMC sections of regulatory filings including CTA/INDs, IMPDs, and briefings for regulatory meetings Contributing to the establishment of suitable Quality Technical Agreements with external vendors Overseeing CRO / CDMO expenditure against approved WOs / SOW and budget, including tracking and approval of invoices and ensuring that our CRO / CDMO partners fulfil their contractual obligations in completing development and manufacturing projects Managing, attending and actively participating in both internal team meetings as well as attending external meetings either online or via offsite visit(s) with external consultants, CROs and CDMOs, as required. Acting as the primary contact for external members of the CDMO/CRO project team Being a proactive member of Enara's Project Management Office (PMO), employing defined best practises and driving innovation by sharing key learnings across projects and identifying and presenting opportunities for process improvement Acting as a champion for Enara Bio values and culture Collaborating with external partners which may include occasional travel to our CRO/CDMO partner sites

Minimum Qualifications and Experience Required

Minimum of a Bachelor's degree or equivalent in a Life Sciences-related discipline Demonstrable / proven experience in successfully managing CMC projects, including the development and manufacturing of biologics Experience in management of interactions with external contract organisations Strong knowledge of the Biopharma industry Excellent interpersonal, communication and presentation skills Ability to work cross-functionally, within matrixed teams, building and maintaining strong working relationships Skilled in prioritising and managing multiple tasks simultaneously Excellent critical thinking, problem-solving skills and conflict resolution Proficiency with related software tools, for example MS Office, Smartsheet Regulatory and cGMP acumen, especially with ICH Q7-Q12, and a relevant Project Management certification (e.g. PMP), is an advantage

Further information:

The Enara Bio team is driven to make a meaningful difference for people affected by cancer. Our culture is defined by our behavioural ethos:

Empowerment:

We promote autonomy across Enara rejecting conventional hierarchy. We engage each other through transparency, collaboration and trust. We each take action with a deep sense of personal and shared accountability.

Courage:

We push boundaries in all that we do to deliver on our purpose. We make bold decisions, embrace risk and tackle challenges to advance our novel science. Courage is essential for everything we do.

Humility:

We are proud of and excited by our novel science, but we acknowledge that we cannot know everything. Our curiosity drives us to continually learn from each other & the outside world irrespective of our role or title. We give and receive feedback with no room for ego.

Growth:

We invest in our people, culture and community to foster belonging as a foundation for success. We embrace individual development to create deeper personal fulfilment and drive stronger collective impact.


We offer a competitive salary, commensurate with qualifications and experience, and a benefits package including pension and health insurance.


Applicants should be able to demonstrate proof of the right to work in United Kingdom.


Enara Bio Limited is an equal opportunities employer.