Upstream Technical Services Specialist
This job does not exist anymore.
Try running a new searchor browse our vacancies.
Or fill in the form below to receive job alerts.
| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Laboratory/ScientificOperations & Manufacturing |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 1002677 |
| Job Views | 337 |
- Description
- Team Horizon is seeking an Upstream Technical Services Specialist for our client’s Bulk Drug Manufacturing Site in Dublin. As the Upstream Technical Services Specialist, you are the technical SME to support the selection and introduction of critical raw materials and single use components.
Upstream (Cell Culture focus) to include media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
Materials: Acting as technical SME to support the selection and introduction of critical raw materials and single use components.
Providing technical leadership for material/component related issues, complaints, and investigations
Identifying opportunities to simplify existing manufacturing processes
Liaising with Vendors to ensure they conduct adequate investigations and implement appropriate corrective actions when issues are identified
Providing significant technical depth to support troubleshooting efforts and deviation investigations in conjunction with Technical Services, Operations, Engineering and Quality
To author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents
To identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to oversee the design and execution of studies
To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements
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
To identify and implement process improvements, e.g. yield, cycle time reduction
To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale
May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution and provide on-call support to manufacturing.
To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution
Lead any key process changes using change control system
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 and participate in risk assessments, audits, and incident investigations
To author and review common technical document (CTD) sections and reports for regulatory agency submissions
To serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections
What you need to apply:
Minimum 2+ years’ experience in Technical Services / Process Development / Manufacturing in a biological bulk drug substance manufacturing organization
Technical and operational knowledge of multiple unit operations in cell culture processing
Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings
Ability to present and defend technical and scientific approaches in both written and verbal form
Ability to drive for results independently and adapt to rapidly changing priorities
Experience of Technology Transfer activities is advantageous
Knowledge or experience of start-up or systems would be ideal
Technical writing competency
Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
M.Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
