Research Associate IV-V, Formulation Development

Recruiter
Regeneron Pharmaceuticals
Location
Tarrytown
Salary
Competitive
Posted
Aug 13, 2017
Closes
Sep 09, 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 experienced Research Associates (levels IV to V) to join the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY.

The successful candidate will work in a state-of-the-art laboratory to support the development of biologic drug products which may include therapeutic antibodies, antibody drug conjugates, bispecific antibodies and recombinant proteins. This is a hands on position which will require the candidate to contribute to all aspects of biologic drug formulation development, including drug candidate screening, analytical method development, pre-formulation, formulation development, compatibility and stability studies. In this role they will support to pre-clinical, clinical and manufacturing teams to move drugs from candidate selection and preclinical development to clinical development and commercialization. The individual will provide technical leadership to junior team member and participate in evaluating and developing new technologies.

Responsibilities may include:

* Leading/ or supporting formulation development and drug product process development activities

* Independently designing, executing and documenting development studies and other experiments to support formulation development, drug process development and/or research stability testing

* Reporting, evaluating, and trending analytical data.

* Troubleshooting, solving problems and communicating the solutions to stakeholders.

* Generating complete, accurate, and concise documentation using electronic systems and laboratory notebook

* Executing protocols and performing assay transfer/validation and equipment qualification/verification

* Developing and applying analytical methods to further the understanding product quality attributes and to support product development and research stability testing

* Evaluating and developing new technologies in the areas of analytical methods, high dose formulation and drug delivery technology

* Performance of general lab instrument maintenance

* May provide technical guidance and/or may train others

* Working collaboratively with other team members and/or other departments to further research initiatives and product development

* May presents technical results at group, department and inter-department meetings

Qualifications and Experience:

* A BS degree with a minimum 7 years of relevant experience or MS degree with a minimum of 4 years of relevant experience in Analytical Chemistry, Biochemistry, Bio-organic Chemistry, Chemical Engineering, Biology, Pharmaceutical Science (or related discipline)

* A proven track record in the area of biologic drug formulation development, drug product characterization, product stability studies, admixture studies, compatibility studies, leachable extractable studies, in-use studies and/or drug product process development

* A solid working knowledge of both the theory and application of HPLC/UPLC (high and ultra-high liquid chromatography, specifically SEC, CEX, HIC RP), CE (capillary electrophoresis, including CE SDS and iCIEF ), experience developing these types of methods is a plus

* Experience using the techniques commonly used to evaluate the level of sub-visible particles in Drug Product which may include Light Obscuration, Micro Flow Imagery, Microscopy, Archimedes

* Method Development, Qualification and Transfer specifically for methods used to characterize the quality or stability of biologic drug products, drug substance or formulated drug substance

* Experience with one or more of the biophysical techniques commonly used to characterize proteins or assess their stability, such as DSC, FTIR, light scattering, UV, CD and fluorescence spectroscopy, or other biophysical characterization methods

* Hands-on experience applying QbD principles to analytical method, drug product and/or process development is highly desirable

* Excellent communication skills, organizational skills and the ability to learn new technologies quickly are a must

* The candidate must be willing to work in a dynamic, fast-paced TEAM 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: 10291BRPosted by StartWire