Will you be our new ambassador?
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team.
Let's look together at your first challenge with us!
Principal QC & Stability Associate
Our partners innovate to bring treatments to their patients that significantly improve their lives. Together with the government and other health partners they are working towards qualitative, affordable and accessible healthcare.
For one of our pharmaceutical partners we are looking for a Principal QC & Stability Associate. In this position it is possible to work on site at either one of two different locations, but also to work remotely.
- Responsible for supporting the management of Contract Laboratory Organizations (CLOs) for release and stability of drug substance, drug products and diluent testing.
- Coordinate sample shipment, deviations, change controls, CAPAs, method improvements and gap assessments.
- Coordinate and manage qualified materials program. Coordinate/Lead multiple site/global projects and represent QC across organizations.
- Contribute to the operation of Stability and Quality release testing programs across a multi  product portfolio, managing timelines to meet corporate goals.
- Execute reagent requests from testing labs (including in-country testing, method transfers) and arrange internally shipment (many countries require special documents)
- Generate release Certificate of analysis from external testing results, assuring compliance to internal specifications.
- Originate ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for commercial and clinical drug product
- Contribute to the preparation and review of CMC stability sections for clinical regulatory filings, MAA, and BLA; Contribute to stability and quality sections of Annual Product Review
- Collaborate with Quality, internal functional areas, and CLOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports
- Complete sample submission forms; Track sample testing status; enter results into LIMS as needed; and Compile and generate stability data tables and reports for commercial and- clinical products for annual product reviews
- Coordinate with CLOs to forecast testing workload at Contract Laboratory Organization (CLO) and works to level load activities at different QC testing sites, as applicable
- Provide inventory, forecasts demand (quantity) and implements assay controls, critical reagents and reference standards at testing sites
- Contribute to maintenance of a list of approved test sites per product, methods performed/site, regulatory approvals per testing site
- Maintain department and project metrics, as appropriate.
- Support oversight of procedure and document changes at CLOs.
- Participate in routine internal and external Operations Meetings
- Frequent inter-departmental, inter-organizational and external interactions
- Reviews and compiles data for CMC dossiers, variations, renewals, annual reports, site registrations and territory extensions as needed
- Support the development and management of quality agreements with internal/external parties
- Financial management and planning of analytical purchase orders for CLO testing activities and reagents, as well as any other planned analytical activities under responsibility
Who are you?
Qualifications/Education & work experience
- In-depth knowledge of FDA/EMA regulations and compliance and can apply that knowledge effectively within a team/project environment
- Behavior competences: It is important that the person has an analytical and quality mind-set, is organized, communicative, flexible, eager to learn and enthusiastic.
- Basic qualification: BS/MS in a scientific discipline with a minimum of 8 years of experience in the pharmaceutical /biotechnology industry.
- Quality Control (QC) experience is necessary, ideally working with external partners (e.g. contract laboratories and suppliers).
- Analytical GMP methods of biologics/antibodies (release and stability of drug substance, drug products and diluent testing), both compendial and non-compendial methods.
- Investigations, Deviations, change controls, CAPAs, method improvements and gap assessments.
- Familiar with regulations (EMA/FDA/…)
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. For this project you have the possibility to work remotely.
Are you interested? Apply now!