Quality Control Technical Resources Specialist
Regeneron is currently looking for a Quality Control (QC) Technical Resource Specialist with a Monday-Friday, 8am-4:30pm schedule. This position supports lifecycle management within the QC Technical Resources groups. Uses and applies scientific knowledge and techniques to perform and review assay development, characterization, optimization, transfer, validation and investigation for the QC group. Provides guidance, technical advice and supervision for release, stability and in-process testing and assay development as a subject matter expert (SME).
As a QC Technical Resource Specialist, a typical day might include the following:
- Engages with Analytical Sciences to bring methods to QC Commercial before process validation; evaluates and determines the appropriate methods to bring to QC Commercial.
- Analyzes and monitors day-to-day method performance in QC lab, including determining if problem resolution requires appropriate subject matter expert to help with any method related issues.
- Works directly with Regulatory Sciences and External Manufacturing and partners and communicates timelines for method validation/transfers to managers in QC Tech Resources.
- Communicates method updates to partners and tracks progress of updates.
- Analyzes, assembles and/or coordinates method performance reports and quality metrics.
- Implements multi-site method harmonization and reviews of method performance.
- Participates in and coordinates in post transfer investigations between contract sites and collaborative partners.
- Tracks team activities and timelines to ensure that the deliverables within the project plans are met and on time.
- Escalates issues to management, as needed.
- Coordinates multi-site trending and reviews and communicates information to SMEs, as needed.
- Continuously drives to improve processes for improved performance.
- Supports investigational identification analysis.
- Performs and/or coordinates assay qualification for the QC Group.
- Drafts new test procedures and assays for QC Group.
- Performs and/or coordinates assay transfers from R&D, internally within QC or to business partners.
- Authors and/or coordinates technical document preparation (Analytical Development Reports, Assay or Process Validation Reports).
- Participates in training programs for QC personnel
This role might be for you if:
- Enjoy working in a fast-paced environment.
- Perform chemical or biological analysis of pharmaceutical or biotechnology products.
- Are able to multi-task, prioritize and execute projects independently and communicate cross-functionally to business units.
- Have experience with troubleshooting assays for testing in a GMP environment.
- Can take on new and sometimes ambiguous challenges and learn quickly.
- Are able to write large technical reports and lead projects.
- Develop and drive scientific and/or business-related improvement ideas.
- Possess effective time management skills, and the drive to meet deadlines.
- Have working knowledge of Microsoft Suite (Word, Excel, Powerpoint).
- Understand working with statistical software such as JMP.
To be considered for the QC Technical Resource Specialist position you must be willing and able to work Monday-Friday 8am-4:30pm.
For various levels you must have the following:
Associate QC Technical Resource Specialist BS/BA in Biology, Life Sciences or related field, 0-2 years of experience or equivalent combination of education and experience.
QC Technical Resource Specialist BS/BA in Biology, Life Sciences or related field, 2 + years of experience or equivalent combination of education and experience.
Sr. Technical Resource Specialist BS/BA in Biology, Life Sciences or related field, 5 + years of experience of equivalent combination of education and experience.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.