Process Development Manager Jobs in Ridgewood, NJ

Regeneron's Preclinical Manufacturing & Process Development (PMPD) organization in Tarrytown, NY is seeking a highly motivated Process Development Engineer III to join our Synthetic and Bioconjugation Scale-up Technologies (SBST) Analytics group. In this role, you will serve as the analytical lead to develop fit-for-purpose analytical methods, transfer, and provide troubleshooting support to advance diverse bioconjugate pipeline. You will lead and implement analytical deliverables working closely with bioconjugation teams and internal/external collaborators (CDMOs) to advance bioconjugate programs from development to commercialization.
A Typical Day in the Role of Process Development Engineer III Might Look Like:

• 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).

This Role May Be For You If You:

• Enjoy working in the lab to advance exciting new drug modalities to patients
• Posses strong initiative and aim to complete challenging tasks and learn new technologies quickly.
• Possess strong hands-on experience and fundamental understanding of analytical techniques and method development for antibody, bioconjugates, and/or synthetic molecule (small molecule, peptides, and oligos) characterization, including relevant software.
• Lead with customer centric mindset with 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.
• Communicate clearly (written and verbal), simplify messages for impact, and build strong working relationships.
• Think critically and apply strong problem-solving skills, and comfortable navigating ambiguity.

This role requires a B.S. with 10+ years of relevant experience, or M.S. with 7+ years or recent PhD with 0-3 years of relevant experience in chemistry, biochemistry, biology, chemical engineering, or a related field. 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). Hands-on 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 decision. Demonstrated initiative, learning agility, and a growth mindset in a fast-paced environment.
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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 Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's 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)
$109,900.00 - $179,300.00