QC Technical Resources Specialist

We are looking for a QC Technical Resources Specialist position with a Monday-Friday, 8am-4:30pm schedule. This role utilizes and applies scientific knowledge and techniques to perform and review assay characterization, optimization, transfer, validation and investigation for QC group. Provides guidance, technical advice, and supervision for release, stability, in-process testing, and assay development as a subject matter expert (SME).

As a QC Technical Resources Specialist, a typical day might include the following:

• Develops and validates methods for raw materials both compendial and non-compendial.
• Supports investigations from a technical perspective for raw material assays.
• 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 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 job might be for you if you have the:

• Ability to quickly learn and adapt.
• Ability to work independently or as part of a team.
• Ability to communicate with transparency.
• Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint).
• Skilled at gathering and organizing information.
• Ability to follow directions and perform well-defined tasks.
• Effective time management skills.
• Excellent written and oral communication skills.
• Ability to develop strategy and create metrics to measure effectiveness of strategy.
• Ability to identify and effectively communicate risks.

To be considered for the QC Technical Resources Specialist role you must be willing and able to work Monday-Friday, 8am-4:30pm. For various levels the following is required: Associate Specialist: Requires BS/BA in a Life Sciences field or equivalent combination of education and experience. Specialist: Requires BS/BA in a Life Sciences field and 2 years of relevant experience in a cGMP environment or equivalent combination of education and experience. Experience with method performance, validation and transfer activities preferred.

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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$63,500.00 - $103,700.00