Senior Associate - Technical Services Manufacturing Science
Posted 5 days ago by Proclinical Staffing
Negotiable
Undetermined
Undetermined
Brampford Speke, England, United Kingdom
Summary: The Senior Associate - Technical Services Manufacturing Science role at Proclinical involves providing technical oversight for finished products in external manufacturing operations within the pharmaceutical industry. The position emphasizes maintaining GMP-compliant documentation, ensuring technical excellence, and supporting efficient production processes, including packaging and product launches. The role requires collaboration with various teams and effective communication of technical information to management and partners.
Key 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:
- 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.
Salary (Rate): undetermined
City: Brampford Speke
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Pharmaceutical Manufacturing
Job 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.