Principal Scientist, Formulation Development (DPDT)

Regeneron; Village of Tarrytown (NY); On-site; USD 128,600 - 210,000; Full time

Job summary

Regeneron seeks a Principal Scientist to lead drug product development activities from candidate selection through commercialization, applying biochemical, biophysical, and microbiology principles to design experiments and processes. Location is on-site in Tarrytown, NY with standard hours and flexibility for meetings.

You will collaborate as an SME within cross-functional teams, mentor junior scientists, use JMP for study design and data analysis, and contribute to publications and patents

Qualifications

• PhD in Pharmaceutical Sciences or related field with 4+ years in biopharma; or BS/MS with 10+ years of relevant industry experience.
• Industry experience with bioconjugates, especially antibody-oligonucleotide formulation development, is preferred.
• Proven ability to lead complex, long-term drug product development projects and communicate results clearly.

Responsibilities

• Lead drug product development activities from candidate selection and pre-clinical development through clinical development and commercialization.
• Design and execute rigorous experiments using biochemical, biophysical, and microbiology principles; apply QbD approaches.
• Mentor junior scientists and train direct reports; present data to cross-functional teams and stakeholders.
• Prepare data presentations, technical reports, publications, and patents; ensure data integrity across ELN, SDMS, LIMS, and EDMS.

Skills

Project leadership

Experimental design

Data analysis

QbD approaches

Mentoring

Education

PhD in Pharmaceutical Sciences

BS/MS with 10+ years experience

Tools

JMP

ELN

SDMS

LIMS

EDMS

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal Scientist to join our Drug Product Development & Technology (DPDT) team. You'll lead drug product development activities from candidate selection and pre-clinical development through clinical development and commercialization for a variety of drug modalities, which may include protein (antibody), siRNA, peptides, bioconjugates (antibody-oligo or antibody-drug), and AAV, across a variety of drug and delivery presentations including liquid and lyophilized DP and novel drug delivery technologies. You'll work independently to lead your project/program(s), applying biochemical, biophysical, and/or microbiology principles to execute both simple and complex experiments and processes. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & Where

• Shift Requirements: Full-time, standard business hours, with flexibility to support before- and after-hours executive meetings, town halls, and corporate events
• Location: On-site in Tarrytown, NY

Discover Your Role

• Works independently and applies technical knowledge to design rigorous experiments that may include formulation, analytical, and process development and technology transfer
• Acts as a resource and is recognized as a subject matter expert (SME) within their field; applies QbD approaches to drug product development and stays knowledgeable about current regulatory guidelines
• Applies scientific and statistical knowledge of software packages (JMP or equivalent) to support study design and data analysis
• Independently makes decisions of moderate complexity in a timely manner, including with limited information, understanding how decisions impact target priorities and cross-functional teams; uses a risk-based approach to make complex decisions and demonstrates judgment on when feedback from management is needed
• Receives information and direction from leadership, and is responsible for planning and leading complex, long-term projects
• Collaborates effectively as an SME and within cross-functional teams to support timely execution of deliverables
• Proactively researches and implements new approaches toward problem-solving and/or process optimization for product development and new technology evaluations; capable of diving into novel fields and developing expertise needed in new areas or technologies
• Brings managerial experience with demonstrated success developing direct reports; trains junior scientists in technical skills and mentors junior colleagues
• Communicates effectively with varied audiences internally and externally, clearly explaining technical data that support recommendations or strategic direction
• Participates in team meetings and prepares data presentations and documents, including publications and patents
• Generates internal reports and authors external documents, which may include protocols, technical reports, risk assessments, regulatory documents, and patents
• Maintains complete and accurate laboratory record documentation and complies with all data integrity procedures and system requirements, including ELN, SDMS, LIMS, and EDMS
• Engages in lab and instrument maintenance activities, acting as instrument SME or team lead, and may champion implementation of new instrumentation and analytical techniques
• Complies with environmental, health, and safety requirements

This Role Requires

• A PhD in Pharmaceutical Sciences, Biochemistry, Chemistry, Biophysics, Biomedical or Chemical Engineering, or a related field with 4+ years of relevant industry experience in the biopharma space; or a BS/MS with a minimum of 10 years, of relevant industry experience
• Industry experience with bioconjugates, particularly antibody-oligonucleotide formulation development, is preferred

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$128,600.00 - $210,000.00