Position: Senior API Manufacturing Scientist
Location: Cramlington
Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.
We’re proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules to biologics and gene therapies, and we work with more than 3,000 global customers. To learn more, visit www.pharmaron.com
About the Role
Pharmaron Cramlington is looking for a Senior Scientist to join our API Operations team, supporting large-scale commercial manufacturing across our production plants. This role sits at the interface between process development and manufacturing, ensuring that chemical processes are effectively scaled up, transferred, and executed in a safe and efficient manner.
In this role, you will provide day-to-day technical support to manufacturing, contributing to process scale-up, troubleshooting production issues, and supporting batch readiness and campaign delivery. Train other members of staff as well as line management responsibility for junior members of staff. You will also be involved in safety-critical activities such as HAZOPs and process reviews, as well as working with cross-functional teams across engineering, quality, and process chemistry.
This is a hands-on role suited to someone who enjoys working in a fast-paced GMP manufacturing environment, is comfortable managing shifting priorities, and takes a proactive, solution-driven approach to technical challenges.
At Pharmaron we offer:
- A vibrant, growing organisation with a dynamic and supportive team environment.
- A state‑of‑the‑art onsite working environment.
- Strong opportunities for professional growth.
- A competitive salary and a comprehensive benefits package.
Key roles and responsibilities:
- Support the scale-up and transfer of chemical processes into manufacturing operations.
- Provide technical support to production, including troubleshooting deviations and resolving process issues.
- Assist with batch planning, production readiness, and campaign delivery activities.
- Contribute to HAZOPs, design reviews, COSHH assessments, and other safety-related activities.
- Supervise and train other members of the API Operations team.
- Prepare and review process documentation including SOPs, batch records, technical notes, and process descriptions.
- Monitor process performance using DCS systems and analyse data to support continuous improvement.
- Support investigations into quality and safety-related events, contributing to root cause analysis and corrective actions.
- Provide temporary instructions to operations teams where required, ensuring alignment with GMP standards.
- Collaborate with cross-functional teams including process chemistry, engineering, QA, and QC.
- Support training activities for manufacturing teams on new processes and products.
Requirements:
- BSc or MSc in Chemistry, Chemical Engineering, or a related discipline
- Experience working in a GMP-regulated manufacturing environment
- Experience of batch manufacturing processes and process scale-up
- Experience in HAZOPs, COSHH assessments, or safety reviews
- Experience training and mentoring others.
- Understanding of process documentation and quality systems (deviation, change control, documentation)
- Strong problem-solving skills with the ability to operate effectively in a fast-paced production environment
Desirable:
- Experience with Distributed Control Systems (DCS), such as DeltaV
- Exposure to process validation or software validation activities
Experience within pharmaceutical, fine chemical, or petrochemical manufacturing environments
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Our Company:
“We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world’s leading pharmaceutical companies, solving what were believed to be unsolvable scientific challenges”.
Our Cramlington site, just north of Newcastle, has an established history of cGMP manufacturing services for an array of Active Pharmaceutical Ingredients (API), ranging from pilot scale to commercial metric ton scale. The Cramlington Site has more than 100 cubic meters reactor commercial capacity and has been inspected and approved by the MHRA, FDA and other regulatory authorities. The site operates from small scale in the laboratory through to large manufacturing scale. It also offers chemistry and analytical development service.
