Regeneron Pharmaceuticals
Associate Director, Formulation Development Group (obesity, metabolic disease)
Regeneron Pharmaceuticals, Tarrytown, New York, United States, 10591
We are seeking an Associate Director within the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY. This role will lead clinical and commercial formulation and drug product development activities for peptides, monoclonal antibodies (mAb), antibody-drug conjugates (ADC), fixed dose combinations, and combination products. Specialized focus on obesity and metabolic disease.
A typical day in this role might look like:
Leads clinical and commercial formulation and drug product development activities for peptides, monoclonal antibodies (mAb), antibody-drug conjugates (ADC), fixed dose combinations, and combination products. Specialized focus on obesity and metabolic disease.
Applies demonstrated knowledge of risk management and application of QbD principles to formulation and drug product development. Integrates analytical and process development.
Interacts broadly and collaboratively with other Regeneron functions and stakeholders including Therapeutic Focus Areas, Pre-clinical Development, CMC and Manufacturing (DS and DP), Program Management, Regulatory, Quality, and Clinical. Demontrates strong collaboration and communication skills.
Actively participates as the subject matter expert in formulation and drug product development within cross-functional teams and at Regeneron Leadership meetings. Contributes expertise to make or inform decisions that set program direction and goals.
Supervises a team of BS/MS and PhD scientists, providing scientific and strategic leadership. Communicate priorities and goals of Regeneron Leadership to the team. Serves as a mentor to develop talent.
Independently sets vision and priorities in alignment with organizational goals. Ensures timely progression for pipeline projects and technology development. Proactively identifies and captures efficiencies.
Key contributor to high quality CMC regulatory filings, approvals, and commercialization of drug products. Ensures compliance with global regulatory and quality requirements.
This role might be for you if:
PhD in Pharmaceutical Sciences, Biochemistry, Biophysics, Chemistry, Biomedical Engineering, Chemical Engineering, or a related discipline. At least 10 years relevant industry experience.
At least 5 years direct managerial experience or demonstrated ability to lead a team within a matrix. Must have provided mentorship and training to scientists and managers (BS, MS, and PhD level). Motivating and positive influence on the team with proven track record in talent development.
Application of QbD principles to the drug development process. Proven track record in developing peptides, monoclonal antibodies (mAb), antibody-drug conjugates (ADC), fixed dose combinations, and combination products.
Experience with developing high concentration formulations or delivery technologies for subcutaneous administration is desirable.
Experience in obesity and metabolic disease is a plus.
Practical knowledge of global regulatory and quality requirements.
PhD in Pharmaceutical Sciences, Biochemistry, Biophysics, Chemistry, Biomedical Engineering, Chemical Engineering, or a related discipline. At least 10 years relevant industry experience
At least 5 years direct managerial experience or demonstrated ability to lead a team within a matrix.
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)
$170,100.00 - $277,500.00
A typical day in this role might look like:
Leads clinical and commercial formulation and drug product development activities for peptides, monoclonal antibodies (mAb), antibody-drug conjugates (ADC), fixed dose combinations, and combination products. Specialized focus on obesity and metabolic disease.
Applies demonstrated knowledge of risk management and application of QbD principles to formulation and drug product development. Integrates analytical and process development.
Interacts broadly and collaboratively with other Regeneron functions and stakeholders including Therapeutic Focus Areas, Pre-clinical Development, CMC and Manufacturing (DS and DP), Program Management, Regulatory, Quality, and Clinical. Demontrates strong collaboration and communication skills.
Actively participates as the subject matter expert in formulation and drug product development within cross-functional teams and at Regeneron Leadership meetings. Contributes expertise to make or inform decisions that set program direction and goals.
Supervises a team of BS/MS and PhD scientists, providing scientific and strategic leadership. Communicate priorities and goals of Regeneron Leadership to the team. Serves as a mentor to develop talent.
Independently sets vision and priorities in alignment with organizational goals. Ensures timely progression for pipeline projects and technology development. Proactively identifies and captures efficiencies.
Key contributor to high quality CMC regulatory filings, approvals, and commercialization of drug products. Ensures compliance with global regulatory and quality requirements.
This role might be for you if:
PhD in Pharmaceutical Sciences, Biochemistry, Biophysics, Chemistry, Biomedical Engineering, Chemical Engineering, or a related discipline. At least 10 years relevant industry experience.
At least 5 years direct managerial experience or demonstrated ability to lead a team within a matrix. Must have provided mentorship and training to scientists and managers (BS, MS, and PhD level). Motivating and positive influence on the team with proven track record in talent development.
Application of QbD principles to the drug development process. Proven track record in developing peptides, monoclonal antibodies (mAb), antibody-drug conjugates (ADC), fixed dose combinations, and combination products.
Experience with developing high concentration formulations or delivery technologies for subcutaneous administration is desirable.
Experience in obesity and metabolic disease is a plus.
Practical knowledge of global regulatory and quality requirements.
PhD in Pharmaceutical Sciences, Biochemistry, Biophysics, Chemistry, Biomedical Engineering, Chemical Engineering, or a related discipline. At least 10 years relevant industry experience
At least 5 years direct managerial experience or demonstrated ability to lead a team within a matrix.
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)
$170,100.00 - $277,500.00