Process Development Leader
3 days ago
About the Role
">We are seeking a skilled Technical Services Specialist to join our team at Hamlyn Williams, a leading pharmaceutical company.
The ideal candidate will have experience in technical services, drug product manufacturing, or process development, and possess strong knowledge of sterile manufacturing processes and single-use systems.
Responsibilities:
- Provide technical leadership and support for sterile manufacturing operations.
- Act as a Subject Matter Expert (SME) supporting technology transfers, process validation, and start-up activities.
- Lead deviation investigations and process troubleshooting, collaborating with Process Development, Quality, and Manufacturing teams.
- Assess and introduce single-use systems, focusing on extractables and leachables.
- Author and review critical documentation, including protocols, validation reports, and technical assessments.
- Support the introduction of new raw materials and consumables, managing materials lists, BOMs, and specifications.
- Review and manage change controls to ensure product quality and regulatory compliance.
- Provide on-the-floor technical support and oversee the execution of technical studies.
- Ensure compliance with cGMP, EHS, and regulatory standards, supporting internal and external audits.
Requirements:
- Degree in Biochemistry, Biology, Chemistry, or Engineering (Chemical, Mechanical).
- Experience in technical services, drug product manufacturing, or process development.
- Strong knowledge of sterile manufacturing processes and single-use systems.
- In-depth understanding of cGMP requirements for clinical and commercial manufacturing.
- Proven skills in problem-solving, troubleshooting, and technical documentation.
- Experience with technology transfers and change control processes.
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