Purpose The Technical Services Specialist has responsibility for providing technical support to the drug product manufacture.
The Technical Services Specialist is accountable for timely completion of all technical transfer related milestones, with particular emphasis on new product introduction, Technology Transfer, supporting start-up studies, building process data packs and performing process monitoring, study protocol generation, execution and report writing.
The position requires effective cross-functional working relationships with Manufacturing, Engineering, Facilities, Logistics, Quality Assurance and Quality Control groups which support day-to-day operations; interacting with Process Development and Analytical sciences for introduction of new products; and providing support for Regulatory submissions to ensure successful facility start up and process qualification.
Responsibilities Provide significant technical expertise to support all aspects of the drug product manufacturing at the company Fill Finish Facility Process SME to support commissioning, automation and manufacturing operation teams.
Support technology transfers of new products into the Facility.
Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.).
SME for introduction of single use systems and assessment of their use in terms of extractables, leachables.
To author and review process supporting documentation, process descriptions, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications.
To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
Technical review of change controls for impact to product quality, safety and efficacy.
Provide on-floor technical support and troubleshooting.
Partner with Operations to support protocol completion, execution and sample reconciliation.
To generate documentation reports for technical studies.
Lead any key process changes using change control management system as required.
Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
Ensure compliance with site EHS policy, cGMP and other business regulations.
Requirements Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
Experience in technical services support in the drug product manufacture and/or process development and/or manufacturing support.
Experienced in relevant unit operations including formulation, sterile filtration, filling and visual inspection activities of the drug product manufacturing process.
Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices.
Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes.
Prior experience in use of single use systems (single use mixers, manifolds) would be an advantage.
Ability to present and defend the technical aspects of manufacturing operations.
Skills: Technical Writing Risk Assessment Technical Transfer Product Transfer Deviations Investigations