Astrellas - A Place to Make a Difference
We are a pharmaceutical company driven by our passion to make a meaningful difference for patients. Our open and progressive culture, guided by the Astellas Way, fosters collaboration, ownership, and a patient-centric approach. We believe that every staff member has a role to play in creating a positive impact.
Our global vision is to support innovative health solutions through a deep understanding of the patient experience. This guiding principle informs our daily work practices and encourages us to think creatively and take action.
The Astellas Way comprises five core values: patient focus, ownership, results, openness, and integrity. These values underpin everything we do and ensure that we maintain the highest standards of quality and safety.
We are committed to providing an inclusive and respectful working environment that allows employees to grow and develop their skills. Our aspiration is to attract the best talent from around the world and provide them with the tools and resources they need to succeed.
The Opportunity:
We are seeking a highly skilled QC Biochemist to join our team. As a key member of our Quality Control department, you will be responsible for supporting operations through completion of all testing required, including receipt, in-process, finished, and stability product testing. You will also have responsibility for tasks associated with analytical method validation, such as technical transfer and pharmacopeial method validation.
Responsibilities:
* Perform tasks in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), ensuring safety compliance in the laboratory and facility.
* Manage analytical technical transfers, qualification of Pharmacopeial methods, and laboratory instrumentation qualifications.
* Oversee product testing, trend reports, and all associated activities; troubleshoot instruments and write reports/procedures.
* Train personnel on biochemical testing processes and document results in LIMS, ensuring peer review.
* Handle incident reports, non-conformances, CAPAs, OOS investigations, and lead QC process improvement projects.
* Author and update laboratory policies, procedures, and data trending, including Continuous Process Verification.
* Proficient in laboratory technologies including LIMS, SAP, Empower, and TrackWise.
* Extensive experience with instrumentation such as icIEF, Capillary Electrophoresis, Liquid Chromatography (ELS, TUV, FLR detectors), Polarimetry, and Moisture content analysis.
* Solid understanding and experience in completing Pharmacopeial testing.
Requirements:
* B.S. degree in Chemistry/Microbiology with relevant industry experience in a Quality Control lab or equivalent.
About Us:
We are an equal opportunity employer and welcome applications from qualified candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.