Job Description
The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change.
Bring your energy, knowledge, and innovation to:
- The Operations Production Specialist will support end-to end production operations for both Fed Batch and Continuous Manufacturing
- Lead/Guide team members within the Production Operations team
- Coach and develop colleagues within the Production team
- Provide designee cover in the absence of the Production Manager
- Operate equipment according to electronic batch records,sampling plans and standard operating procedures.
- Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization, and robustness improvement projects.
- Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
- A Change and QRA Champion within the organization and site, to bring about new technologies, digitization, and identify opportunities to bring new ways of working.
- Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external groups
- Support weekend or on-call duty on select time frames to support manufacturing as POC (point of contact) and POE (point of escalation)
- Conduct all work activities with a strict adherence to the safety and compliance culture on siteSupport the Authoring of electronic batch records, sampling plans, and standard operating procedures.Support the development of GMP Documentation such as: Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs/WI’s.
What skills you will need:
- Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
- 6 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components).Position level will scale with experience level of candidate.
- Competent in analysing complex situations and show practical problem-solving capabilities.
- Ability to work independently and within a cross-functional team.
- Understanding of multi column chromatography concepts
- Familiarity with contamination control and batch release requirements
- Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits
- Problem, Deviation, and Change Management experience
Preferred Experience and Skills:
- Commissioning and Qualification experience
- Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
- Familiarity with Emerson DeltaV, SIPAT,and the use of Automation in a manufacturing Process.
Current Contingent Workers apply
No Travel Required
Not ApplicableNot Indicated
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.