ASSOCIATE DIRECTOR / DIRECTOR CMC

About Maxion

Maxion Therapeutics is a biotechnology company developing antibody-based drugs for previously untreatable ion channel- and G protein-coupled receptor (GPCR)-driven diseases, including autoimmune conditions, chronic pain, and cardiovascular disease.

The Company is developing a pipeline of potentially first- and best-in-class therapeutics using its proprietary KnotBody technology to generate potent, selective, and long-acting therapeutics by combining naturally occurring mini-proteins (‘knottins’) with antibodies using state-of-the-art phage and mammalian display technologies.

Maxion was founded in 2020 by highly respected biotech entrepreneurs and scientists Dr John McCafferty, CTO and Dr Aneesh Karatt-Vellatt, CSO. Dr McCafferty previously co-invented antibody phage display, which was the subject of the 2018 Nobel Prize in Chemistry awarded to his co-inventor Sir Gregory Winter. Maxion’s portfolio and growth is being advanced by a team of highly experienced leaders in the discovery and development of antibody-based drugs. The Company is based near Cambridge, UK and is backed by international blue-chip investors. For more information, please visit:

https://www.maxiontherapeutics.com/.

About the Role

We are seeking a highly organised and proactive CMC professional to oversee and manage the CMC activities for our lead programme, MAX001, currently in IND-enabling development. Reporting directly to the Chief Development Officer (CDO), the successful candidate will assume full responsibility for managing and coordinating the manufacturing process from process development through to the manufacture of Drug Product batches. The ideal candidate will have a strong background in managing biologics manufacturing activities, excellent communication skills, and a collaborative approach to working with Contract Development and Manufacturing Organisations (CDMOs).

Key responsibilities

• Manage all aspects of the CMC process for MAX001, from late-stage preclinical development to clinical supply manufacture.
• Serve as the primary point of contact and actively collaborate with the CDMO to ensure efficient, timely, and high-quality manufacturing.
• Monitor, control, and report on manufacturing timelines, deliverables, and project budgets and transparently communicate progress to the program team and senior management
• Oversee process development activities, analytical method development and validation, and stability studies conducted by the CDMO.
• Provide expert input and collaborate closely with the CDMO on Module 3 regulatory documentation (IND/IMPD).
• Support in house development of Upstream, downstream and analytical methods
• Ensure compliance with all relevant regulatory, quality, and GMP requirements.
• Communicate and collaborate effectively with internal teams, including Regulatory, Clinical Operations, Quality Assurance, and senior management.

Candidate Profile

• Degree in Life Sciences, Chemistry, Pharmaceutical Sciences or equivalent relevant experience.
• CMC and manufacturing experience within the biotech or pharmaceutical industry.
• Proven track record of successfully managing biologics or antibody-based therapeutics manufacturing processes, preferably through IND-enabling studies into clinical stages.
• Hands-on experience managing external CDMOs, including manufacturing process oversight, troubleshooting, and analytical method development.
• Demonstrated experience supporting or authoring CMC regulatory documentation, particularly Module 3.
• Strong project management, organisational, and communication skills.
• Ability to effectively manage priorities, problem-solve proactively, and adapt to rapidly evolving project demands.
• Actively contributing to a vibrant and innovative working environment where improvements and new ideas are adopted and freely shared among the teams.
• Desire and ability to work in a fast-paced, quickly changing environment, showing agility/flexibility to meet deadlines and goals with a can-do attitude.

What can we offer you?

• A competitive salary
• A comprehensive benefits package including generous pension contribution, Private Life and Medical Insurance, Cycle to Work Scheme, participation in the company Share Option Scheme, and more.
• Significant opportunities for career progression within a dynamic company.
• Located in a state-of-the art Science Park with easy access to Cambridge by car, train and bus, and offering on-site gym, cafe, and a vibrant social community.
• Working alongside an innovative team of scientists, including the founders, who are Key Opinion Leaders in the field.
• A supportive work environment with a key focus on fostering collaborative working environment within a friendly team.

To apply for this position, you MUST click on the link to upload your CV and covering letter outlining your suitability for this role, including your salary expectations via our careers page or through the advert.

This is a permanent position.

Agencies: We are recruiting this role directly with our in-house talent team, so do not need support from agencies. We also have our own preferred suppliers list which is not being reviewed for additions in the next 12 months.