Analytical Development Lead

Cycle Pharmaceuticals; Cambridge; On-site; GBP 70,000 - 95,000; Full time

Benefits offered by this job

Hybrid work

Company pension

Private health insurance

Life insurance

Critical illness insurance

Gym membership

Team building

Performance bonus

Job summary

Cycle Pharmaceuticals Ltd in Cambridge seeks an Analytical Development Lead to drive analytical strategies across development projects. You will lead external CDMO collaborations, review data and reports, and support regulatory submissions to bring medicines to market.

The role demands strong analytical capabilities, knowledge of USP/ICH standards, and a track record in method development and validation. Hybrid working and career growth are offered.

Qualifications

• Degree in Pharmaceutical Sciences, Chemistry or analytical discipline.
• Strong analytical development experience in pharma.
• Knowledge of USP, ICH and regulatory requirements.
• Ability to review data, protocols and reports and prepare GMP documentation.

Responsibilities

• Act as analytical SME across development projects and oversee external CDMOs.
• Review and interpret data, protocols and reports from CDMOs.
• Support stability studies, specifications, and degradation assessments.
• Contribute analytical expertise to regulatory submissions and responses.
• Identify analytical risks and implement mitigation strategies.
• Coordinate analytical activities across external partners and labs.
• Provide progress updates to project teams and stakeholders.
• Support procedures, templates and scientific standards development.

Skills

Analytical development experience

Data interpretation

Regulatory submissions knowledge

GMP documentation

Method development & validation

Problem solving

Cross-functional collaboration

Education

Degree in Pharmaceutical Sciences, Chemistry or analytical discipline

Job description

Analytical Development Lead

Cycle Company: Cycle Pharmaceuticals Ltd

Position Summary: This full-time position is within the Product Development team working in our Cambridge office on a hybrid basis (minimum 3 days in the office).

We have an exciting opportunity for an analytical development professional who wants to join our successful and growing business where you can make a real impact. As our analytical subject matter expert, you'll take the lead on development projects across a diverse portfolio of products playing a key role in bringing new pharmaceutical products from development to market. You'll ensure reliable data is available to support the development of new medicines, clinical trials and regulatory applications.

You’ll collaborate closely with colleagues across Regulatory Affairs, Quality, Supply Chain and external partners, ensuring robust analytical strategies that support successful product development and regulatory submissions.

Our Company

At Cycle, we believe that Every Single Patient Matters. This is at the heart of why we work and were looking for people to join our team who share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen.

Our growing portfolio now covers oncology, haematology, neurology and rare metabolic genetic conditions where we improve existing drugs, repurpose them for new uses and bring generics back to market. Using cutting-edge drug delivery technologies, we enhance the efficiency of treatments, offering patients greater freedom and choice.

Headquartered in Cambridge, UK, with a significant US presence, Cycle has scaled rapidly and was named one of the UK’s fastest-growing private companies by The Sunday Times (Sunday Times 100 2024 & Sunday Times 100 Tech 2025). If you want to know more about what we do then, why not check out our website and take a look at some of our patient stories: Patient Stories - Cycle Pharma

What You’ll Be Doing In This Role:

• Act as the analytical subject matter expert across development projects.
• Oversee analytical development work conducted by external CDMOs.
• Review and interpret data, protocols and reports from our CDMOS (Contract Development and Manufacturing Organisations).
• Support stability studies, specification setting and degradation assessments.
• Contribute analytical expertise to regulatory submissions and health authority responses.
• Identify analytical risks and implement effective mitigation strategies.
• Stay up to date with regulatory requirements, industry trends and emerging technologies.
• Manage analytical workstreams to deliver projects on time and within budget.
• Coordinate analytical activities across external partners and laboratories.
• Ensure analytical deliverables align with project objectives and development plans.
• Proactively identify and resolve technical challenges and risks.
• Provide regular progress updates to project teams and stakeholders.
• Provide technical guidance and analytical expertise to cross-functional teams.
• Represent Analytical Development within project teams and support programme delivery.
• Contribute to continuous improvement initiatives and best practices.
• Support the development of procedures, templates and scientific standards.

The following skills and experience will be important in helping you to succeed in this role:

• Degree in Pharmaceutical Sciences, Chemistry, Analytical Chemistry or a related scientific discipline.
• Confidently demonstrate strong pharmaceutical analytical development experience.
• Knowledge of a range of analytical characterisation techniques
• Experienced in reviewing and interpreting analytical data and technical reports.
• Working knowledge of USP, ICH and regulatory requirements.
• Strong problem‑solving and scientific data interpretation skills.
• Proven ability to develop optimise and validate analytical methods.
• Skilled in authoring and reviewing GMP‑compliant analytical documentation.

Desirable Skills That Would Be Beneficial But Not Essential:

• Knowledge of oral solid & liquid dosage forms.
• Capable of supporting NDA, ANDA, 505(b)(2) or equivalent regulatory submissions.
• Experience with stability studies and degradation pathway investigations.
• Knowledge of Quality by Design (QbD) and statistical evaluation of analytical data.
• Familiarity with GMP analytical laboratory environments.

What Can We Offer To You

In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will enjoy all the benefits that brings:

• Competitive salary based on experience
• Hybrid working environment
• A collaborative high performing work environment
• Performance based bonus
• Opportunity to join a fast growing and ambitious business
• Company pension scheme
• 100% employer paid membership for Private Health Insurance
• Life and Critical Illness Insurance
• Corporate Gym membership
• Regular team building events and an agile working environment

Diversity And Inclusion Statement

At Cycle Pharmaceuticals, we are committed to creating an inclusive, respectful, positive and diverse workplace. We do not discriminate on the basis of race, colour, religion, gender, age, disability, or any other protected characteristic. We actively support and embrace diversity, and we are working to build a team that reflects a wide range of backgrounds and perspectives.

We value your unique contributions and encourage you to join us in shaping a more inclusive future. If you require any reasonable adjustments - whether during the application process or in the workplace - we will be happy to support your needs. At Cycle, equality, inclusion, and respect are at the core of everything we do. We fully comply with all applicable employment laws, including those related to non-discrimination, work authorization, and employment eligibility verification.