Sr. Associate Scientist - Formulation Process Development

Initial Therapeutics, Inc.; Village of Tarrytown (NY); On-site; USD 79,000 - 130,000; Full time

Job summary

An established industry player is seeking a Sr. Associate Scientist to join their Formulation Development Group. In this pivotal role, you will support drug product process development studies for biologics and gene-based modalities. You will collaborate with leads and scientists to ensure seamless technology transfer to manufacturing sites, providing essential technical support throughout the process. This dynamic position requires strong problem-solving skills and the ability to adapt quickly to changing priorities. Join a diverse and inclusive team that values innovation and offers comprehensive benefits, including health programs and equity awards, making this an exciting opportunity for growth and impact.

Benefits

Health and Wellness Programs

Fitness Centers

Equity Awards

Annual Bonuses

Paid Time Off

Qualifications

• 6+ years of relevant industry experience in drug product development.
• Hands-on experience with analytical instruments for biologics.

Responsibilities

• Plan and execute drug product process development studies.
• Prepare and review technical reports and presentations.

Skills

Analytical Instruments

Problem Solving

Communication

Critical Thinking

Multitasking

Education

BS in Biomedical or Chemical Engineering

MS in Biomedical or Chemical Engineering

Tools

HPLC

Statistical Software (JMP)

Job description

Regeneron's Formulation Development Group (FDG) Process Development Team is seeking a Sr. Associate Scientist to support drug product process development studies for biologics (e.g. monoclonal antibody) and gene-based (e.g. viral delivery such as AAV) modalities. The candidate will work closely with FDG leads and scientists to ensure 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:

• Plan, optimize, design, and execute drug product process development studies to ensure robust characterization of different unit operations (freeze/thaw, lyophilization, mixing, filtration, filling, etc.).
• Assist in developing small-scale models to effectively mimic manufacturing unit operations and support technology transfer to manufacturing teams.
• 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.
• 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 6+ years of relevant industry experience or a MS degree with 3-6+ years of relevant industry experience. Experience with drug product development and characterization (formulation and process). Hands-on experience with analytical instruments used for biologics and gene-based therapeutics including HPLC-based chromatographic techniques (icIEF, SEC, IEX), biophysical methods (DLS, DSC, and UV-Vis), particle characterization methods (MFI and HIAC) required and vector quantification methods (ddPCR, ELLA) preferred. Basic understanding of common protein degradation pathways. Experience with statistical software is a plus (JMP).

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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)

$79,100.00 - $129,100.00