Specialist CTSM GCP Operations

BioNTech; Greater London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A global biotechnology firm in Greater London is seeking a qualified individual to lead the development of trial-specific manuals and support GCP operations. The ideal candidate will have a degree in Pharmacy or related field, professional experience in clinical supply, and a strong understanding of GCP principles. Excellent communication and problem-solving skills are essential. This role offers a full-time position with competitive remuneration and various employee benefits.

Benefits

Competitive remuneration packages

Variety of employee benefits

Qualifications

• A degree in Pharmacy, Chemistry, Biotechnology, Biochemistry, or related disciplines.
• Experience in hospital/pharmacy settings or clinical supply in pharma/biotech.
• Familiarity with global clinical trial supply and GCP.

Responsibilities

• Lead development of trial-specific manuals and guides.
• Support GCP Operations in addressing handling queries.
• Manage complaints and deviations related to GCP topics.

Skills

Pharmacy knowledge

Clinical supply experience

GCP principles

Communication skills

Problem-solving abilities

Education

Completed university education in relevant fields

Vocational training in pharmacies or hospitals

Tools

MS Office

TMF management

Job description

About the Role:

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London, United Kingdom; Mainz, Germany; Munich, Germany | full time | Job ID:10680

Your Contribution:

• Lead the crossfunctional development of trial-specific IMP Manuals and pharmacy questionnaires guide drug handling processes at clinical trial sites.
• Support the Manager GCP Operations in addressing IMP handling queries promptly, providing expert support to clinical teams.
• Contribute to the review of monitoring manuals and other GCP-related documents, enhancing operational precision.
• Manage complaints, deviations, changes, and quality incidents related to GCP topics effectively.
• Develops Work Instructions to ensure consistent adherence to best practices and SOPs.
• File and maintain key CTSM documents within Trial Master Files (TMF), ensuring compliance and accessibility.

A Good Match:

• Completed university education in Pharmacy, Chemistry, Biotechnology, Biochemistry or related disciplines; vocational training in pharmacies or hospitals (e.g. Pharmacy technician) is also welcomed.
• Professional experience in hospital/pharmacy settings or clinical supply within the pharmaceutical/biotech industry (<3 years preferred).
• Knowledge of IMP mManuals, pharmacy /questionnaires and medical writing skills.
• Comprehensive understanding of GCP principles (e.g., ethical considerations, adequate drug information).
• Familiarity with global clinical trial supply up to Phase III.
• Proficiency in TMF management and electronic filing systems.
• Strong command of standard office tools like MS Office and business‑professional English language skills.
• Excellent communication skills coupled with curiosity and openness to learn new topics.
• Reliable problem‑solving abilities with a diligent approach to complex tasks.

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech‑Recruiter.

We are looking forward receiving your application.

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