Senior Associate - Technical Services Manufacturing Science

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.comProclinical 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.