Senior Staff Scientist (Assay Development)

Location
Tarrytown, NY, United States
Posted
Mar 21, 2019
Ref
15684BR
Required Education
Associate Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary
Senior Staff Scientists in the Assay Development Scientists supervise several Assay Development Associates and Ph.D level scientists in the development and validation of immunoassays, showing strong decision making abilities in their area of expertise. They create development strategies for the developmental projects assigned to their direct and indirect reports and guide all the assay development efforts within their group. They will be responsible for guiding assay development efforts for multiple drug programs, establishing deliverables and communicating program objectives to project teams. Their in-depth understanding of the science and technology enables them to independently drive the development and validation of assays and guide the work of others. They understand the project goals and their impact on corporate timelines. They independently seek out any available background information, through literature searches, external meetings and informal discussions. They are acknowledged leaders within the group and serve as a resource for scientific and technical questions.

Responsibilities
  • Supervises several Associate level scientists in the development and validation of immunoassays for the measurement of drug, drug complexes and anti drug antibodies to support all necessary sample analyses for all pre-IND, post-IND and pre-BLA deliverables.
  • Supervises Assay Development Scientists and Post-Doctoral fellows in their developmental projects and oversees their guidance of their direct reports.
  • Guides the designs and execution of immunoassays (PK, PD and ADA) by direct reports, based on protocols provided by literature, seminars and other scientists. Suggests troubleshooting experiments for assay-related problems and follow-up experiments to further assay development and optimize assays. Suggests modifications to protocols or alternative protocols.
  • Drives forward the developmental programs under his/her responsibility to meet corporate timelines. Ensures the scientific quality of the data.
  • Functions as Study Director for assay validation studies conducted by direct reports. Writes/reviews assay validation protocols, validation reports and SOPs prior to submission to Quality Auditing (QA) for auditing.
  • Communicates with QA to schedule critical phase audits for validation studies and to convey timelines for audit of such documents. Prepares audit responses for submission to QA.
  • Routinely reviews data for multiple developmental projects conducted by direct reports, working on these projects simultaneously.
  • Oversees the performance of Long Term Stability (LTS) studies for validated methods. Amends validation reports to incorporate LTS data and ensure method SOPs are updated with LTS information.
  • Reads and critically evaluates the literature in a specialized scientific field.
  • Trains other PhD level scientists and ADAs on his/her area of technical expertise. Serves as a role model and mentor within the group.
  • Communicates effectively with supervisor and other members of the Assay Development Group. Summarizes and presents results internally to management and externally in industry meetings.
  • Participates in multi¬≠disciplinary meetings such as joint project teams as Assay Development representative to help direct drug development programs. Collaborates closely with colleagues and partners. Drafts or edit bioanalytical assays sections for IND and BLA submissions.
  • Effectively communicate company goals to subordinates and provide clear updates to senior management.
  • Communicates with other groups within the company and/or outside vendors to obtain assay-related reagents or discuss reagents needs.
  • Stimulates, develops, and promotes the scientific career development of direct and indirect reports.
  • Leader within the group that effectively drives projects forward to meet aggressive timelines.
  • Serves as a role model; acts with integrity in all aspects of work and ensures the ethical and professional conduct of direct reports.
  • May evaluate new technologies for the development of immunoassays using new formats or techniques.
  • Maintains GLP compliance for all laboratory work and documentation related to assay validations in accordance with FDA regulations and company SOPs. Assists in maintaining GLP compliance in the laboratory.
  • Learns and complies with safety requirements of his/her laboratory. Recognizes potential safety problems and takes action to correct them.

Requirements:
  • Minimum of six (6) years of post-degree laboratory experience.
  • Industry experience, working in a regulated environment, is required.
  • Experience developing and/or validating pharmacokinetics (PK), biomarkers and immunogenicity (ADAs and MAbs) assays
  • Experience supervising laboratory personnel and managing multiple development projects simultaneously is preferred.
  • Strong oral and written communication skills

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.