Process Development Engineer III, Analytical Science: Synthetic and Bioconjugation Scale-Up

About the role

The Process Development Engineer III, Analytical Science: Synthetic and Bioconjugation Scale-Up in the Preclinical Manufacturing & Process Development (PMPD) organization at Regeneron Pharmaceuticals, Inc. in Tarrytown, New York, serves as the analytical lead to develop fit-for-purpose analytical methods, transfer, and provide troubleshooting support to advance diverse bioconjugate pipeline. This role involves independently designing and executing analytical testing, method development and characterization, leading and implementing analytical deliverables, authoring high-quality documentation, driving business workflows, maintaining compliance with lab and environmental safety requirements, and mentoring and supporting peers and junior team members.

Responsibilities

• Independently design and execute analytical testing, method development and characterization to enable bioconjugate process development.
• Serve as the subject matter expert to lead and design analytical deliverables: robust method development, method transfer to internal/external receiving labs, training, and troubleshooting to move program forward.
• Connect, interpret, communicate complex results into clear actionable next steps to technical and non-technical audiences to persuade and drive timely decisions.
• Author high-quality documentation (i.e., procedures, development and characterization reports, ELN entries) in a timely manner to support program timelines.
• Drive, build and improve business workflows: documentation standardization, data digitization, and sample management.
• Maintain compliance with lab and environmental safety requirements and promote a safe lab environment.
• Proactively scout, evaluate, and implement new or improved technologies for high-throughput analytics and real-time decision making.
• Lead equipment upkeep, troubleshooting, maintain an organized workspace, and proactively plan for lab resources.
• Mentor and support peers and junior team members (direct and/or indirect via matrix).

Requirements

• Bachelor's degree with 10+ years of relevant experience, or Master's degree with 7+ years, or recent PhD with 0-3 years of relevant experience in chemistry, biochemistry, biology, chemical engineering, or a related field.
• Strong hands-on experience and fundamental understanding of analytical techniques and method development for antibody, bioconjugates, and/or synthetic molecules (e.g., small molecule, PEG, peptides, and/or siRNA) such as electrophoresis, HPLCs, LC-MS, UV spectroscopy, plus associated software (e.g., Empower).
• Experience in transferring methods to internal/external labs, and troubleshooting.
• Demonstrated experience serving as an analytical lead for bioconjugate programs, collaborating effectively with internal teams and external CDMOs.
• Strong written and verbal communication skills, including the ability to present data clearly to diverse audiences.
• Experience drafting analytical methods, development and characterization reports to support regulatory filing.
• Ability to work independently and collaboratively across cross-functional teams to persuade and drive data-based decisions.
• Demonstrated initiative, learning agility, and a growth mindset in a fast-paced environment.

Qualifications

• Hands-on experience with analytical method development for antibody, bioconjugate, and/or synthetic molecules (e.g., small molecule, PEG, peptides, and/or siRNA) such as electrophoresis, HPLCs, LC-MS, UV spectroscopy, plus associated software (e.g., Empower).
• Experience in transferring methods to internal/external labs, and troubleshooting.
• Experience serving as an analytical lead for bioconjugate programs, collaborating effectively with internal teams and external CDMOs.
• Strong written and verbal communication skills, including the ability to present data clearly to diverse audiences.
• Experience drafting analytical methods, development and characterization reports to support regulatory filing.
• Ability to work independently and collaboratively across cross-functional teams to persuade and drive data-based decisions.
• Demonstrated initiative, learning agility, and a growth mindset in a fast-paced environment.

Skills

• Strong initiative and aim to complete challenging tasks and learn new technologies quickly.
• Strong hands-on experience and fundamental understanding of analytical techniques and method development for antibody, bioconjugates, and/or synthetic molecules (e.g., small molecule, PEG, peptides, and/or siRNA) such as electrophoresis, HPLCs, LC-MS, UV spectroscopy, plus associated software (e.g., Empower).
• Customer-centric approach to providing analytical support to advance drug development in different phases of the program.
• Thrive in a fast-paced, highly collaborative environment working on complex problems.
• Clear communication skills, including the ability to simplify messages for impact and build strong working relationships.
• Critical thinking and problem-solving skills, comfortable navigating ambiguity.

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 here.

Pay

$109,900.00 - $179,300.00 annually

Schedule

Full time