Director Drug Product Formulation Development Jobs in Ridgefield, CT

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a highly motivated Sr. Scientist to join our Process Development (PD) team within the Drug Product Development and Technology (DPDT) department. In this role, you will plan and execute drug product (DP) process development activities, developing cross-scale models, supporting risk assessments, and leading technology transfer to manufacturing sites, while helping set up in-house drug product process development capabilities. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Location: Tarrytown, NY

Flexibility & travel: Soml travel to CMO partners and to conferences; must be available on-site consistently, including to maintain coverage during staff absences and critical site events

Other requirements: Routine lifting of items over 30 lbs will be necessary

• Lead DP process development activities for different unit operations across multiple programs
• Support implementation of cross-scale models to successfully bridge the gap between lab and manufacturing while supporting the increasing pipeline of new modalities
• Ensure effective characterization of different unit operations for a seamless technology transfer to the manufacturing sites
• Support setup of in-house DP process development capabilities in the Formulations Development Group, including laboratory layout and setup, procuring tools and equipment, overseeing equipment installation and operation, and working closely with formulation development, manufacturing, and facility management teams to develop full functionality of the DP process laboratory
• Independently design, execute, and document formulation, fill and finish development studies to understand the impact of process parameters on product quality attributes
• Write complete internal and/or external "publications" that require minimal revisions (i.e., peer reviewed publications, patents, business plans)
• Routinely author and review guidelines, protocols and reports, regulatory sections, and risk assessments to support technology transfer to manufacturing sites
• Present work at group, department, and cross-functional meetings, and contribute as a process lead in drug development team meetings
• Seek out, recognize, and assess existing and new technologies to improve process development capabilities in the Formulations Development Group, serving as a knowledgeable resource on prevalent manufacturing-related technologies and processes

• Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical or Biomedical Engineering (or related subject area) with 0-3 years of relevant industry working experience, a MS with 8+ years, or a BS with 10+ years
• Ability to work effectively in a team environment and capacity to quickly adapt to changes in project direction
• A consistent record of publications with creative, productive, and insightful statistical-based analysis
• Excellent oral/written communication skills and interpersonal skills to support frequent interactions with collaborators

• Experience with biologics drug product (formulation and process) development and characterization
• Strong capability with analytical instruments in characterizing protein therapeutics
• Proven skills and understanding in support of GMP manufacturing, quality, and regulatory functions
• Hands-on experience and know-how of DP process related unit operations
• Experience in developing and implementing small-scale models
• Thrive today. Grow tomorrow.

• Student Loan Paydown program & Tuition Reimbursement
• Family Care Benefits
• Relocation Assistance
• Inclusion, Culture and Well-Being programs (including physical & mental health)
• 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
• Family support benefits

$109,900.00 - $179,300.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

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. 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.