Senior R&D Specialist (Formulation Process Development)

Location
Tarrytown, NY, United States
Posted
Apr 12, 2019
Ref
15683BR
Required Education
Bachelors 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
Sr. R&D Specialist in the Formulation Development Group (FDG) will lead planning, optimization and execution of DP process-based unit operations, will develop scale-down models and will support technology transfer to manufacturing teams. The Sr. Specialist will work closely with FDG leads/scientists and will lead development activities across multiple programs. The Sr. Specialist will also support full functionality and maintenance of the state-of-the-art process development laboratory, including procurement of tools and equipment as well as installation and operation. Additionally, the position will independently design, execute, and document studies to assess impact of process parameters on product quality attributes.

Responsibilities

• Independently designs and executes DP process development activities for different unit operations across multiple programs. Develops small scale models to effectively mimic manufacturing unit operations and support technology transfer to manufacturing teams

• Works very closely with FDG leads/scientists to ensure seamless progression of multiple late-stage process-related activities.

• Contributes towards setup of in-house drug product (DP) process development capabilities in Formulations Development Group. Responsibilities include supporting laboratory layout and setup, procuring tools and equipment, overseeing equipment installation/operation/maintenance, and working closely with key members of formulation development and facility management teams to ensure full functionality of DP process laboratory.

• Leads writing, reviewing and editing technical reports

• Communicates effectively across levels and groups, can engage with others and work in cross-functional teams to support process development

• Shares information in a clear and transparent manner, and effectively takes in information through strong listening skills.

• Brings in new ideas from literature or external practices. Engages in active questioning to understand context and interpretation of work.
Requirements

• BS or MS degree in Biomedical or Chemical Engineering, Pharmaceutical Sciences, or related field with at least 6 years of relevant industry experience

• Experience with drug product (formulation and process) development and characterization

• Possesses strong capability with analytical instruments in characterizing protein therapeutics such as HPLC-based chromatographic techniques (especially SEC, IEX), biophysical methods such as DLS, DSC, UV-Vis, and particle characterization methods such as MFI, HIAC

• Basic understanding of common protein degradation pathways. Prior research experiences in the areas of protein structure, stability, and protein aggregation

• Excellent oral and written communication skills

• Possesses ability to work independently or in a team setting and has strong problem-solving skills.

• Can quickly adapt to change to support accelerated timelines and has efficient time management 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.