Senior Staff Scientist, Formulation Development

Recruiter
Regeneron Pharmaceuticals
Location
Tarrytown
Salary
Competitive
Posted
Aug 13, 2017
Closes
Aug 15, 2017
Industry
Chemical
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
Position Summary

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:

We are seeking a Senior Staff Scientist to lead key analytical method activities for the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY.

This Senior Staff Scientist will be responsible for efforts within the formulation development group that are focused on the development, demonstration of fit for purpose and transfer of analytical methods that are used to characterize and assess the stability of DS, FDS and DP. In addition this Senior Staff Scientist will serve as a technical expert in the key areas of analytical method development, the identification of and implementation of new analytical technologies.

Responsibilities Include:

* The selected candidate will be responsible providing strategic direction for analytical activities related to large molecule clinical programs. This will include directing the development and implementation of analytical methods to characterize recombinant protein therapeutics and antibody drug conjugates

* Leads method development and transfer activities at various stages of Drug Product development

* Serves as a functional representative at the cross functional teams for formulation, stability, product manufacturing, QC and other CMC related issues

* Lead a formulation development team; provide guidance, trainings, and assistance to the team members in developing methods and demonstrating they are fit for purpose

* Authors and reviews method development reports, technology transfer documents, and relevant CMC sections of regulatory documents

* Leads or participates in developing best practices of various drug product development with and emphasis on analytical methods and characterization

* Lead and participate in the assessment and development of new technologies to expand the groups' analytical capabilities, promotes innovation and ensure state of the art analytical capabilities are available.

* Over sees the operation of the groups analytical instrumentation and provides guidance with respect to instrument trending, operation and qualification

Qualifications and Experience:

* Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Science, Chemical or Biomedical Engineering (or related discipline) with a minimum 7 years relevant working experience in developing analytical methods for biological drug products and or characterizing biological drug products.

* Prior experience with characterization of recombinant monoclonal antibodies and/or other

protein therapeutics which may include antibody drug conjugates

* Extensive practical and theoretical expertise in high-performance liquid chromatography

(HPLC/UPLC), capillary electrophoresis (CE), and the techniques and methods commonly used to characterize sub-visible particles in biological drug products

* Demonstrated experience in the biophysical techniques frequently used during protein formulation development, which may include DLS, Fluorescence spectroscopy, FTIR, CD, DSC, Light Scattering, and Raman

* Has successfully transferred analytical methods from development into GMP facilities including QC

* Has experience with the material testing techniques commonly used to assess drug product pre-filled syringe and device function

* Is knowledgeable on the techniques commonly used to identify leachable and extractable compound in biologic drug products

* Hands-on experience in global regulatory filing for biologics, such as IND, IMPD, and BLA. Familiar with the global regulatory requirements for biologics CMC.

* Demonstrated track record of working in cross functional teams and effectively coaching and motivating team members.

* Has the ability to develop team consensus and influence team direction

* Excellent written and verbal communication skills; demonstrated ability to align with the management and to work with the cross functional teams.

* Experience with applying QbD principles to method, product and/or process development.

* Able to work independently to design experiments, as well as interpret, document, and communicate results

* The candidate will have exceptional written and verbal communication skills, and be highly self-motivated and eager to learn.

* The candidate must be willing to work in a dynamic, fast-paced environment, and be capable of handling multiple tasks while meeting timelines and adapting to changing priorities

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.

Requisition Number: 10290BRPosted by StartWire