- Reference: CJ46269
- Job Type: Contract
- Location: Cork, Cork City, Munster
- Category: Science, Pharmaceutical & Food
The person will participate and lead on various projects, analytical techniques and testing issues in the large Cork site. Responsible for support of Technical Transfer, Process Validation, Manufacturing investigations, Life Cycle Management and Health Authority Inspections.
- Supports 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.
- Apply analytical knowledge to interpretation of generated data and ensure high quality of the delivered results working with senior colleagues.
- Overall release and stability management of product(s) according to portfolio: Evaluate chemical and physical trends. Assist in drawing conclusions on shelf-life, retest period and storage instructions.
- Participate in projects as single point of contact building product stability expertise.
- Takes Lead on critical Lab Continuous Improvement projects and/or serve as representative on cross functional/Process teams.
- Write SOP’s, protocols, reports and IMPD/IND regulatory filing documents.
- Proactively identifies and drives process improvements.
- Acts as subject matter expert on assigned analytical techniques.
- Presents technical analytical data clearly and concisely to customers, i.e., internal and external regulatory inspections.
- Supports 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.
- Keeps abreast of analytical technology and compliance trends.
- Execute assigned NME transfer programs and related projects.
Key Skills required:
- Innovative solutions/technical skills to troubleshoot laboratory issues.
- Customer focus and results and performance driven
- Sense of Urgency.
- Ability to work well within team structures and provide leadership.
- Solid knowledge of physical, chemical and biological techniques is required.
- Excellent communication skills
- Good scientific and technical writing skills
Education and Experience:
- A minimum of a Bachelor’s degree in Biology, Pharmacy or related scientific field is required
- At least 3 years experience or related post graduate academic experience is required.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
- Practical analytical laboratory experience in a GMP environment is required.
For a confidential discussion and more information on the role, please contact Laura Jevens on 021 4911060 or email firstname.lastname@example.org
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