Job DetailsRegeneron is looking for a Project Specialist to support the Technical Resources team! This position supports lifecycle management within the QC Technical Resources groups. It 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 Project 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 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 you have:
- The ability to work independently or as part of a team.
- The ability to communicate with transparency.
- Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint).
- Skills at gathering and organizing information.
- The ability to follow directions and perform well-defined tasks.
- Effective time management skills.
- Excellent written and oral communication skills.
- The ability to develop strategy and create metrics to measure effectiveness of strategy.
- The ability to identify and effectively communicate risks.
To be considered for the Project Specialist position you must be willing and able to work Monday-Friday, 8am-4:30pm. Various levels require the following:
- 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 step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.Salary Range (annually)$59,700.00 - $108,400.00