Senior Scientist

About the job

Job Role : Senior Scientist, Drug Product

Location : Cambridge (Hybrid)

Company Overview

Our client is an emerging biotechnology company advancing a pipeline of small molecule therapeutics. The organisation works through an outsourced development model, partnering with contract development and manufacturing organisations (CDMOs) to progress assets from preclinical development through to clinical and commercial supply.

As the business scales its CMC capability, this role offers the chance to build and own the drug product function from an early stage, with genuine influence over formulation and manufacturing strategy rather than executing against an established playbook.

The Senior Scientist, Drug Product will act as the internal expert on formulation and manufacture of oral solid dose products, taking ownership of programs from early development through to validated, commercial-ready processes.

Key Responsibilities

• Own the formulation strategy for one or more oral solid dose small molecule programs, from early development through scale-up and into commercial manufacture.
• Select, manage and hold accountable external CDMO partners for formulation development, GMP manufacture and technology transfer activities.
• Take technical responsibility for manufacturing campaigns, ensuring clinical, registration and commercial batches are delivered on time, on budget and to specification.
• Anticipate formulation and supply chain risk across programs and put mitigation plans in place ahead of time.
• Act as the drug product voice on cross-functional CMC teams, feeding into wider development strategy alongside drug substance, quality and regulatory colleagues.
• Draft and review CMC documentation - development reports, validation reports, and drug product sections of regulatory filings (IMPD, IND, NDA, MAA).
• Support the regulatory team in preparing responses to health authority questions and, where needed, take part directly in agency interactions.
• Translate complex formulation data into clear technical reports and presentations for both scientific and non-scientific stakeholders.

Qualifications &​ Experience

• PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry or a related discipline; candidates with an MSc/BSc and substantial industry experience will also be considered.
• Solid track record in pharmaceutical or biotech industry roles focused on oral solid dose formulation and drug product development.
• Direct experience managing CDMOs or other outsourced manufacturing partners.
• Familiarity with GMP expectations and CMC regulatory requirements across clinical development stages.
• Some involvement in regulatory submission content, whether authoring or reviewing.
• Comfortable operating with a high degree of autonomy while staying closely aligned with cross-functional partners.
• Able to communicate technical findings clearly to audiences without a formulation background.

Preferred Experience

• Exposure to registration and validation-stage manufacturing, not just early clinical supply.
• Hands-on experience with scale-up, process validation and technology transfer projects.
• Involvement in health authority meetings or inspection readiness.
• Experience working with CDMOs across multiple geographies.
• Background in a small or growth-stage biotech, where processes and ownership are still being defined.
• Working knowledge of Quality by Design (QbD), risk-based development approaches and ICH guidance.

To Apply

In the first instance please send your resume and any relevant supporting details for consideration to: william.hinton@morganprestwich.com