Senior Scientist

About the job Job Role : Senior Scientist, Drug Substance 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 substance function from an early stage, with genuine influence over process and manufacturing strategy rather than executing against an established playbook.

The Senior Scientist, Drug Substance will act as the internal expert on process development and manufacture of small molecule drug substances, taking ownership of programs from early development through to validated, commercial-ready processes.

Key Responsibilities Own the process development strategy for one or more small molecule drug substance programs, from early development through scale-up and into commercial manufacture.

Select, manage and hold accountable external CDMO partners for process development, GMP manufacture and technology transfer activities.

Take technical responsibility for manufacturing campaigns, ensuring clinical and commercial batches are delivered on time, on budget and to specification.

Anticipate technical and supply chain risk across programs and put mitigation plans in place ahead of time.

Act as the drug substance voice on cross-functional CMC teams, feeding into wider development strategy alongside drug product, analytical, quality and regulatory colleagues.

Draft and review CMC documentation — development reports, validation reports, and drug substance 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 process data into clear technical reports and presentations for both scientific and non-scientific stakeholders.

Qualifications candidates with an MSc/BSc and substantial industry experience will also be considered.

Solid track record in pharmaceutical or biotech industry roles focused on small molecule process development, scale-up and manufacture.

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 chemistry background.

Preferred Experience Exposure to registration and commercial-stage manufacturing, not just early clinical supply.

Hands-on experience with 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 (Qb D), 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