Senior GMP Scientist - Camden Area, United Kingdom - Northreach

Description

Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced therapy, fintech, and digital sectors.

Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.

Position Overview

Maintain meticulous records including batch documentation, equipment logs, and production records in collaboration with team members, ensuring full compliance with cGMP regulations.

Adherence to current Good Manufacturing Practices (cGMP) and internal Standard Operating Procedures (SOPs).
Perform routine operation, maintenance, inspection, and cleaning of equipment as per operational guidelines.
Swiftly identify and address routine non-conformances/deviations during GMP manufacturing processes.
Promptly report safety incidents or hazards to senior staff.
Provide support for Process Development studies.
Develop and document Validation Lifecycle Strategies aligned with EU GMP and regulatory requirements.
Ensure thorough qualification and validation of facility, equipment, and processes in accordance with national, international, and ISO standards.
Review and implement necessary SOPs/protocols for processes, equipment, and systems.
Propose validation and qualification approaches, strategies, priorities, and resource requirements for new projects or re-qualification needs.
Lead Quality & Validation (Q&V) activities including planning, project management, and execution.
Serve as Subject Matter Expert (SME) for Q&V and provide validation training.
Collaborate closely with internal and external teams, including suppliers and collaborators.
Participate in external supplier audits as necessary.
Facilitate communication and coordination among internal and external stakeholders involved in qualification and validation activities


Experience, Knowledge, and Skills:
Proficiency in cell culture and cell therapy manufacturing processes.

Minimum 3 years of experience working in a GMP environment with knowledge of local QMS systems and compliance with EU GMP/EMA/ICH standards.

Strong understanding of Quality Management Systems (QMS) and cGMP regulations.
Ability to work independently and as part of a team in a fast-paced environment.
Prior experience with validation in a GMP setting, including equipment validation.
Familiarity with regulatory guidelines and ensuring compliance with EU GMP/ICH/FDA/EMA standards.
Professional demeanour with excellent attention to detail.
Technical proficiency with common computer software packages.
Strong communication and problem-solving skills.


Desirable:
Experience participating in audits.
Knowledge of Technology Transfer processes.
Experience in retinal pigmented epithelial, stem cell, and retinal photoreceptor cell generation, culture, and/or GMP manufacturing.

Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age.

We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI.

We strive to create a welcoming and inclusive environment for all employees.