Technical Operations Associate
Role Overview
Full-time role in the Technical Operations team within the Operations and Regulatory department.
Works on lifecycle management of commercial products and technical processes, collaborating with vendors and internal stakeholders.
Applications are welcomed at Associate and Senior Associate levels.
The role is based in the Cambridge office on a hybrid basis, with a minimum of three days in the office.
Key Skills for This Role
Full Job Posting
Position summary
Full-time role in the Technical Operations team within the Operations and Regulatory department.
Works on lifecycle management of commercial products and technical processes, collaborating with vendors and internal stakeholders.
Applications are welcomed at Associate and Senior Associate levels.
The role is based in the Cambridge office on a hybrid basis, with a minimum of three days in the office.
Responsibilities
- Support commercial API and drug product manufacturing across the contract manufacturing network, including investigations, change controls, and CAPAs.
- Build relationships with third-party vendors and support manufacturing improvement projects against timelines, costs, and milestones.
- Cover for the Technical Team during absences and help plan and scope cost-reduction and robustness projects.
- Maintain knowledge of relevant guidance, particularly US FDA-focused guidance.
- Execute commercial product tasks under SOPs and guidelines, suggest process improvements, and contribute to data trending, risk assessments, deviation investigations, and change controls.
- Participate in projects, discussions, and team meetings.
Candidate requirements
- Scientific or engineering degree, or equivalent pharmaceutical or life sciences industry experience.
- Practical pharmaceutical industry experience with at least one listed manufacturing process: tablet compression, wet or dry granulation, coating, encapsulation, lyophilisation, or solution/suspension manufacturing.
- Knowledge and application of ICH guidelines.
- Proactive and autonomous approach, teamwork, relationship-building, and ability to work unsupervised.
- Strong analytical, organisational, and problem-solving skills, with quality focus and attention to detail.
Desirable skills
- Analytical QC method development or validation is desirable.
- Risk assessment, Lean Six Sigma, Quality by Design, and data trending or associated statistical knowledge are desirable.
Benefits
- The package includes a performance-based bonus, company pension, employer-paid private health insurance, life and critical illness insurance, corporate gym membership, and team-building events.
- Core working hours are 10am to 4pm.
About Cycle Pharmaceuticals
Cycle Pharmaceuticals focuses on rare metabolic, immunological, and neurological genetic conditions and develops, repurposes, and returns treatments to market.
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