- BBBH788299 Jul 22, 2021 Competitive
Our client, a global leader in biopharmaceuticals, has several permanent opportunities open across process sciences. This is an exciting time to join as they are growing significantly.
These roles will support, among others, the following processes: Cell Culture, Protein Purification, Aseptic / Sterile Manufacturing and Vaccines Conjugation.
Which department you will support will be dictated by your experience and interests. Some key skills that are being sought after for said roles are as follows:
- Tech Transfer
- Upstream/Downstream manufacturing
A general synopsis of the role is as follows:
- Key member of the tech transfer team, working within site Technical Services supporting the transfers of products (including mRNA products) and representing the site at key internal and external tech transfer meetings.
- Capture the all aspects of the existing process and equipment to ensure that an equivalent process is transferred to the site
- Technology Transfer, including Gap Analysis, Process Transfer Risk Assessment, process description, new material introduction support etc.
- Execute requisite process trials to facilitate transfer as required
- Develop process validation protocols and lead their execution in conjunction with Operations.
- Generate process validation summary reports and associated filing submissions.
- Ensure the process automation meets the requirements of the process
- Process input to equipment specification process, including equipment sizing, specification of key components, verification documentation and process instrumentation ranges.
- Liaise with site functions - logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer
- Lead major process investigations as requested and support the implementation of CAPAs.
- Provide technical training on process and technology areas as required by the project.
- Provide independent decision making for strategic input into the facility & equipment design, support site operational readiness (equipment, process understanding etc.).
- Deliver presentations that convey complex ideas and proactively communicate results and progress to technical teams, management, and business leadership.
- Be competent with Quality Systems, including Change Controls, Commitments and Maintenance systems.
- Support Compliance Inspections and enquiries from Regulatory Agencies.
- Minimum of 2 - 5 years' experience working in a manufacturing process; process development or tech transfer environment
- Knowledge of technical transfer/Validation
- Demonstrated aptitude for technical learning and problem solving.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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