- Key member of the tech transfer team, working within site Technical Services supporting the transfers of new products into the drug substance facility and representing the site at key internal and external tech transfer meetings.
- Capture all aspects of the existing process and equipment to ensure that an equivalent process is transferred to Grange Castle
- 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 to GC.
- 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 distil 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.
- Provide technical oversight of routine process monitoring and follow-up on any significant adverse trends.
- Perform Continuous Processing Monitoring (CPV) on commercial processes.
- Minimum of 2 – 5 years' experience working in a manufacturing process; process development or tech transfer environment
- Knowledge of technical transfer
- Demonstrated aptitude for technical learning and problem-solving.
- Strong background in mammalian cell culture, protein purification or validation.
- Good communication skills.
- Experience of FDA and EU licensing desirable.
- Demonstrated technical capability and aptitude for technical learning.
- Strong evidence of problem-solving/troubleshooting skills.
- Ability to independently plan and perform work assignments, interpret and present data.
- Capability of working in a multidisciplinary team environment.
- Strong interpersonal skills with an ability to work independently across sites and teams.
- Highly motivated, proactive, and persistent.
- Effective communication (verbal, written).
Process Scientist - Dublin, Ireland - Cpl
Description
Cpl in partnership with our client Pfizer are currently recruiting for a
Process Scientist - Small Scale Flex
Background:
This is an ideal development opportunity to join a dynamic team who provide process science support/ new product tech transfer into the drug substance facility at Pfizer Grange Castle.
The jobholder works with the Technical Services teams to deliver integrated technical services to meet the site business objectives. The role requires the flexibility to move from one project quickly or to work on multiple smaller projects at the same time.
Our Culture is hugely important to us at Grange Castle. It is the embodiment of how we act, lead, and engage with people every day. Our vision is, together, we deliver life-changing medicines to our patients. Our success is achieved through the commitment, engagement, and excellence of all our colleagues.
We Are Seeking Process Scientists/Engineers Whose Role Will Be:
Requirements
Skills: