Main duties and responsibilities:
* Apply analytical knowledge to interpretation of generated data and ensure high quality of the delivered results working with senior colleagues in AD.
* 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 under the guidance of the Scientific Integrator.
* 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 and Competencies 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.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists