- 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 support of clinical release and stability testing.
- 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.
- 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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