Role Overview
The successful candidate will carry out hands-on production activities within a GMP manufacturing environment, following approved batch records and standard operating procedures to ensure products are manufactured right-first-time, safely, and in full compliance with regulatory requirements. This role suits a production-experienced chemist who can integrate quickly into an established shift team with minimal ramp-up time.
Key Responsibilities
- Execute production activities in line with approved batch manufacturing records (BMRs) and standard operating procedures (SOPs).
- Operate, set up, and clean production equipment in accordance with GMP and site EHS requirements.
- Accurately weigh, dispense, and process raw materials and intermediates, maintaining full traceability.
- Perform in-process controls (IPCs) and sampling as required, recording results accurately and in real time (good documentation practice).
- Complete batch documentation contemporaneously, ensuring data integrity and audit-readiness at all times.
- Identify and escalate deviations, equipment faults, or quality concerns promptly to the Production Supervisor/Manager.
- Support cleaning validation, changeover, and line clearance activities between batches/products.
- Work collaboratively with Quality, Engineering, and Validation teams to resolve production issues and support continuous improvement.
- Adhere to all site health & safety, gowning, and cleanroom (where applicable) requirements.
- Participate in shift handover, ensuring clear and accurate communication of production status.
Essential Qualifications & Experience
- Degree or equivalent qualification in Chemistry, Pharmaceutical Science, or a related scientific discipline (or equivalent relevant production experience).
- Demonstrable production experience within a GMP-regulated pharmaceutical, biopharmaceutical, or related manufacturing environment.
- Strong working knowledge of GMP, good documentation practice (GDP), and data integrity principles.
- Practical experience with batch manufacturing records, in-process testing, and production equipment operation.
- Comfortable working the site's required shift pattern, where applicable.
- Available to start within a short notice period, given the contract nature of the role.
Desirable Criteria
- Experience specific to the site's process type (e.g. sterile/aseptic manufacturing, oral solid dose, API/drug substance, or biologics).
- Experience with specific production equipment relevant to the site (e.g. tablet presses, granulation, fill-finish lines, bioreactors).
- Prior contract/temporary manufacturing experience, with the ability to integrate quickly into an established team.
- Manual handling, forklift, or other site-specific operational certifications.
- Experience with electronic batch records (EBR) systems.
Person Specification
- Meticulous attention to detail, particularly around documentation accuracy and process adherence.
- Reliable and punctual, with the flexibility to work the required shift pattern consistently.
- Strong team player, comfortable working closely within a shift-based production team.
- Safety-conscious, with a proactive approach to identifying and reporting hazards or non-conformances.
- Quick to learn site-specific processes and equipment, given the contract timeframe.