- Reference: CJ46023
- Job Type: Contract
- Location: Cork, Cork City, Munster
- Category: Science, Pharmaceutical & Food
- Leads early and late phase Technical Transfer activities through generation of protocols/reports, technical writing, execution of laboratory scale studies and participation in manufacturing operations and NPI initiatives.
- Leads early and late phase product development activities through generation of protocols/reports, execution of laboratory scale studies and participation in Lean Early Development initiatives as required.
- Leads “process fit to plant” during early and late stages of development to provide guidance to both development and manufacturing teams.
- Leads “man in plant” by providing support during manufacturing campaigns for new products or during process validation campaigns.
- Provides expertise to development teams on manufacturing facility design and capabilities, scale-up considerations and GMP operations.
- Partner with Project Teams to provide input, review and approval support for BLA submissions
Focus and Scope:
- Participate in and/ or Lead cross-functional project teams.
- Interpret project plans and timelines for CMC projects, and schedule work and experiments to meet these goals.
- Assist in manufacturing investigations as required, in particular event, deviations and CAPAs, to help meet product release specifications and timelines.
- Execute experimental plans and protocols to support product life-cycle improvements, process validation requirements, technical transfer projects and development activities as required.
- Foster a culture of Lean and Continuous improvement within the department and with internal and external partners
- A minimum of a Bachelor’s degree in Biology, Pharmacy or related scientific field is required, advanced degree is preferred.
- Minimum 5 years experience in pharmaceutical or biotechnology industry.
- Biological process development or commercial manufacturing experience, either cell culture and/or purification.
- Excellent communication, skills, both oral and written.
- Capable of planning and executing experiments or projects steps with some supervision.
- Ability to work well in a team environment, strong collaboration skills and flexibility.
- Excellent interpersonal skills with the ability to adapt to rapid changes in project priorities and requirements.
- Collaboration and Teaming
- Integrity and Credo Based-actions
- Results and Performance Driven
For a confidential discussion and more information on the role, please contact Laura Jevens on 021 4911060 or email email@example.com
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