Neil Birkett Email & Phone Number

Cambridge, GB

• Led the CMC Process Development function, ensuring the generation and optimisation of fermentation and purification processes for Crescendo’s multi-specific therapeutics. Accountable for outsourced CMC activities.
• Membership of CMC Leadership Team.
• CMC project lead, successfully project managing all internal CMC and cross-functional activities from pre-candidate nomination to 200L-scale engineering run over 24 months.
• Presented to project governance meetings.
• Directed process design ahead of successful Phase I clinical manufacture and process optimisation and scale-up strategy looking forward to Phase II/Phase III manufacture of our lead programme.
• Fostering a collaborative team environment across multiple disciplines to get the best performance and science-driven results; recruiting and training talented scientists to build a diverse team (7 FTEs)

Cambridge, GB

Head of CMC Process Development activites, duties were very similar to those outlined above.

Cambridge, GB

Led Health & Safety activities at Crescendo Biologics, coordinating multiple activities such as management of GMO, process & chemical risk assessments, new starter and other H&S training, regular office/lab inspections, document revision as appropriate.

Cambridge, GB

• Company lead for the design and optimisation of downstream purification processes for novel Humabody therapeutics across multiple projects. Forming part of the initial CMC team at Crescendo.
• Managing the DSP transfer into and ongoing oversight of external manufacturing activities to support pre-clinical studies and clinical trials.
• Lead purification specialist for internal non-affinity-based purification activities, both high-throughput and larger scale.
• Temporary (9-month) lead of Crescendo's Analytical function, with responsibility for protein QC and method development for the whole company, covering LC-MS, SEC- and RP-UPLC, CE-SDS, Protein A titre, and affinity.
• Training new team members and establishing standard protocols.
• Line management and performance evaluation.

Cambridge, GB

• The Protein Sciences team is responisble for production of high-quality candidate drug molecules, antigens and other tool reagents as required for Crescendo’s internal discovery activities, using microbial and.
• Co-leading the team from April 2018 onwards.
• Company expert for tag-free purification process development and automated robotic purification.
• Line management of direct reports; recruitment; coaching and development of junior scientific staff.

Gaithersburg, Maryland, US

• Member of Purification Process Sciences team within BioPhamaceutical Development department, working cross-functionally with many of our Research and Development teams in the UK and USA.
• Purification process development for clinical manufacturing of antibody-based therapeutics.
• Large scale material production for pre-clinical studies (g-kg amounts).
• Led development and implementation of automated micro-scale purification processes to support cell line development, bioreactor process development and purification process development.
• Presented scientific findings to a wide variety of audiences (internal and external).
• Coached and trained other members of the team.

Gaithersburg, Maryland, US

• Led of a small, dedicated team responsible for the expression and purification of antibody fragments and other drug candidates to support all therapeutic projects at MedImmune Cambridge.
• Operational management of the team, producing 100+ samples per week.
• Optimised the expression and purification methods and troubleshot issues to ensure reliable and timely delivery of samples.
• Line management and performance evaluation responsibilities.
• Drove continual process optimisation and technical innovation
• Presented scientific findings to a wide variety of audiences.

Gaithersburg, Maryland, US

Member of a small, dedicated team responsible for the expression and purification of antibody fragments and other drug candidates to support all therapeutic projects at MedImmune Cambridge.Responsible for process development.Significantly improved team delivery by bringing in new equipment and streamlining processes already in place.

Cambridge, England, GB

Blackfriars, London, GB

Worked in Ice Cream research department for 3 summers and Measurement Sciences department for 1 summer (3 months per year).Developed method to model the rheology of ice cream matrix in its frozen stateDeveloped novel aeration methods to enable freshly made ice cream preparation at a point of sale, home or vending machine, resulting in patent filing.

Phd, Biophysics

Ba, Msci, Natural Sciences