Scientist - Formulation Process Development

BioSpace; Village of Tarrytown (NY); On-site; USD 93,900 - 153,300; Full time

Benefits offered by this job

Health and wellness programs

401(k) company match

Paid time off

Annual bonuses

Job summary

A leading biopharmaceutical company located in Tarrytown, NY is seeking a Scientist to support drug product process development for biologics, including monoclonal antibodies and other modalities. The ideal candidate will have a strong background in drug product development, hands-on experience with analytical instruments, and the ability to work independently and in a team. Responsibilities include conducting risk assessments, executing development studies, and managing technical reports. This role offers competitive compensation and comprehensive benefits.

Qualifications

• 10+ years of relevant industry experience or a MS degree with 8+ years.
• Experience with drug product development and characterization required.
• Hands-on experience with analytical instruments for biologics required.

Responsibilities

• Perform gap and risk assessments for drug product.
• Plan and execute process development studies for biologics.
• Manage process development equipment and technical reports.

Skills

Drug product development

Analytical instruments

Problem-solving

Team collaboration

Education

BS degree in Biomedical or Chemical Engineering

MS degree with 8+ years experience

Tools

HPLC

Statistical software (JMP)

Job description

Regeneron's Formulation Development Group (FDG) Process Development Team is seeking a Scientist to support drug product process development studies for biologics, including traditional monoclonal antibody (mAb) and non-traditional modalities (e.g. AAV, antibody tethered ligand, etc.). The candidate will work closely with FDG leads and scientists to ensure robust process development and seamless technology transfer to various manufacturing sites and to provide technical support towards GMP manufacturing, validation campaigns, and post-launch activities.

A Typical Day In The Role Might Look Like

• Perform gap and risk assessment for drug product (e.g. manufacturing process, scale, contact parts, etc.) to inform requisite process development studies.
• Plan, design, and execute drug product process development studies for various biologics to ensure robust characterization of different unit operations (freeze/thaw, lyophilization, mixing, filtration, filling, etc.) across a number of fill sites.
• Assist in developing small-scale models to effectively mimic manufacturing unit operations and support technology transfer to manufacturing teams.
• Support in-house drug product toxicological lot manufacturing campaigns as needed.
• Work closely with FDG leads/scientists to ensure seamless progression of multiple late-stage process-related activities.
• Prepare, review, and edit technical reports.
• Bring in new ideas from literature and present work at group, department, and cross-functional meetings with a goal to improve efficiencies (e.g. in-silico modeling approaches, process analytics and related tools).
• Demonstrate strong and proactive problem‑solving skills via critical thinking and effective communication.
• Manage process development equipment installation, operation, maintenance, calibration, and repairs.

This Job Might Be For You If You Have

• The ability to work effectively independently as well as within a team environment.
• Capacity to multitask and quickly adapt to changes in priorities, as needed.
• Strong initiative and drive to complete challenging tasks and learn new technologies.

This position requires a BS degree in Biomedical or Chemical Engineering, Pharmaceutical Sciences, or related field with at least 10+ years of relevant industry experience or a MS degree with 8+ years of relevant industry experience. Experience with drug product development and characterization (formulation and process) required. Experience with lyophilization is desired. Hands‑on experience with analytical instruments used for biologics including HPLC‑based chromatographic techniques (icIEF, SEC, IEX), biophysical methods (DLS, DSC, and UV‑Vis), particle characterization methods (MFI and HIAC) required. Other quantification methods (ddPCR, ELLA, mass photometry) preferred. Basic understanding of common protein degradation pathways and biophysics required. Experience with statistical software (JMP) to perform design of experiments and statistical analyses preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries specific benefits, please speak to your recruiter.

Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regenerons roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about Regenerons on‑site policy and expectations for your role and your location.

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)
$93,900.00 - $153,300.00