Ob Title: Senior Associate - Technical Services Manufacturing Science (TSMS)
Job Function: Technical Services - Manufacturing Science
Therapy Area/Industry: Pharmaceutical Manufacturing
Location: Speke, United Kingdom
Job Description:
Proclinical is seeking a Senior Associate to provide technical oversight for finished products within external manufacturing operations. This role focuses on ensuring technical excellence, maintaining GMP-compliant documentation, and supporting efficient production processes. The position also involves expertise in packaging processes and materials, as well as participation in product launches, technical transfers, and network initiatives.
Responsibilities:
- Provide expertise in packaging processes and materials.
- Act as the primary TSMS contact in Joint Process Team (JPT) meetings, ensuring compliance with global technical standards.
- Oversee key batch processing records, including SOPs, Master Production Records, and SPIs.
- Write and review technical reports to communicate process metrics and project statuses.
- Conduct site visits to contract manufacturers to assess capabilities and resolve technical issues.
- Develop and maintain control strategies for assigned products.
- Identify and implement continuous improvement opportunities using data and process knowledge.
- Support the generation and review of Annual Product Reports (APRs) and Product Quality Reviews (PQRs).
- Manage product and process transfer projects, including new product introductions and technical transfers.
- Investigate deviations and complaints in collaboration with TSMS Leads and Operations teams.
- Represent technical information to senior management and external partners clearly and effectively.
Key Skills and Requirements:
- Advanced degree or equivalent experience in life sciences, engineering, or related fields (e.g., pharmacy, chemistry, chemical engineering, veterinary medicine, packaging engineering).
- Fluency in English; additional European languages are a plus.
- Strong understanding of pharmaceutical or chemical production processes, technical services, and packaging.
- Proficiency in applied statistics, quality systems, and regulatory requirements across multiple health authorities.
- Excellent project management and communication skills, with experience working in interdisciplinary and multicultural teams.
- Expertise in technical transfer and production process management at manufacturing scale.
- Ability to write high-standard technical documents and reports, adhering to cGMP requirements.
- Strong problem-solving skills, with experience in statistical data analysis and process improvement.
- Flexibility to travel (10-30%) to meet business deadlines and customer needs.
If you are having difficulty in applying or if you have any questions, please contact Dean Fisher on d.fisher@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. Proclinical Staffing is an equal opportunity employer.