Group Leader - Upstream Process Development

Group Leader – Upstream Process Development

Roles: Full-time, permanent

Location: Harrow, London

Salary: Competitive + bonus + benefits

The Role

Due to continued growth at our new Biopharma labs, we’re seeking a proactive and meticulous Group Leader to support and manage our Upstream Process Development department, delivering phase-appropriate Upstream processes (from early development and characterisation to commercialisation and tech transfer), all in-line with required regulatory, company and industry standards. Leading a growing team of Research Associate / Scientists, you will drive and oversee our Upstream Process Development activities (including fed-batch / perfusion intensification strategies and lifecycle innovation for process robustness, scalability and quality) and set the technical strategy associated with the production of our Biosimilar and Biological products, using state of the art equipment to work on monoclonal antibodies (Mabs) and other therapeutic proteins (from cell line selection to the generation of drug substance), including collaboration with CROs and strategic manufacturing partners. Managing the progress of our cell culture work to GLP standards, you’ll contribute scientific expertise by performing, leading and troubleshooting a broad range of cell culture techniques, including cryopreservation, clone screening, early- and late-stage process development, process characterisation and technology transfers.

In this exciting role, you’ll manage the delivery of key internal projects, working collaboratively with the different workstream teams and providing regular feedback to the R&D Leadership Team. You’ll also respond to queries from our Regulatory Affairs team to support interactions with the EMA, MHRA and FDA and the completion of CMC sections of regulatory submissions (e.g. Module 3 – BLA / MAA / IND / IMPD). To ensure quality levels are maintained, you’ll oversea and participate in regular safety audits, risk assessments and data reports, as required.

The Person

• Experience in a similar team management role in an Upstream Process Development area of a biopharma / biotech lab / research lab, with experience working with CDMO and tech transfer.
• Practical experience of mammalian cell culture (CHO, HEK), fed-batch / perfusion bioreactor systems and scale-up for GMP manufacturing.
• Experience of working with Ambr platforms (5 – 10 litre Bioreactors) and other process analytical equipment is essential in this role, whilst knowledge of PAT scale-up would be beneficial.
• Strong knowledge of regulatory expectations (FDA, EMA, MHRA) and CMC dossier preparation (Module 3 – BLA / MAA / IND / IMPD).
• Familiarity with process validation, control strategies and QbD principles.
• Excellent communication skills (in written and spoken English), you’re confident liaising with all levels of seniority and navigating cultural differences.
• Strong interpersonal skills with experience of leading, building and motivating teams.
• Strong organisation skills, able to manage conflicting tasks to meet deadlines and to solve problems on your feet, even in a busy and changeable work environment.
• Good IT and data analysis skills using MS Excel.
• PhD/Masters level qualification in a life science, molecular biology, immunology, cell biology, biochemistry, pharmacy, chemistry, biomedical science or other technical scientific discipline.

The Rewards

In return, we offer a competitive salary and rewards package (including holiday, bonus and pension scheme). Not to mention the opportunity to genuinely make a difference in a new and dynamic role within a progressive and expanding business, at an exciting time of growing international reach.

How to Apply

If you possess the experience, passion and ability to make this role a success then we would like to hear from you. Please send your CV and cover letter to us using the ‘apply’ button below. The closing date is 03/08/2025. For more information, you can contact us on: [email protected]

A Bit About Us

Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive, always seeking to improve products and patients' access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide.

To continue our growth, we’re looking for the best and brightest technical minds and forward-thinking business professionals. Keeping our people at the heart of all we do, we offer rewarding opportunities for those looking for continued personal and professional growth, investing in training and development tailored to each individual’s focus. So, if you’re looking for an inclusive company to take your career to the next level, you’re certainly in the right place; come and join us to make it better.