Sr. Manager, Microbiology Formulation Development

BioSpace; Village of Tarrytown (NY); On-site; USD 150,500 - 245,500; Full time

Benefits offered by this job

Health and wellness programs

401(k) company match

Annual bonuses

Paid time off

Job summary

A leading pharmaceutical company in Tarrytown, NY, seeks a talented Sr. Manager in microbiology to oversee laboratory operations and a team of microbiologists. The role involves managing microbiological studies to support product development, ensuring compliance with regulations, and mentoring staff. Candidates should possess a strong background in microbiology with over 15 years of industry experience. This position provides a competitive salary and comprehensive benefits, emphasizing on-site collaboration.

Qualifications

• 15+ years experience with BS or 12+ years with MS in the pharmaceutical industry.
• 8+ years of leadership experience.
• Knowledge of antimicrobial effectiveness testing and microbial risk assessment.

Responsibilities

• Oversee microbiology research studies supporting product development.
• Manage a team of microbiologists and ensure high-quality work.
• Communicate findings effectively to stakeholders.

Skills

Microbiology expertise

Leadership

Regulatory knowledge

Data analysis

Education

BS or MS in Microbiology or related field

Job description

Overview

We are seeking a talented and driven Sr. Manager with expertise in microbiology to join the Formulation Development Group at Regeneron Pharmaceuticals Inc., located in Tarrytown, NY. In this role, you will oversee the operations of the microbiology testing laboratory, manage a team of microbiologists, supervise daily activities, and lead microbiological studies to support Regeneron’s product development, as well as testing for toxicology and clinical materials.

Responsibilities

• Conducting and overseeing microbiology research studies and experiments to support product development.
• Collaborating with cross-functional teams to design and execute microbiology studies that meet regulatory requirements and company standards.
• Developing and qualifying microbiological assays and methods to support drug development.
• Analyzing and interpreting microbiology data, generating reports, and presenting findings to key stakeholders.
• Managing and mentoring a team of microbiologists, providing guidance and ensuring high-quality work.
• Planning and executing microbiology-related projects and timelines.
• Communicating effectively with internal and external partners, including presenting at scientific conferences and representing the company in external collaborations.
• Engaging with leadership and extended leadership teams to advance product development.
• Maintaining accurate and detailed records of experiments and results in compliance with company policies and procedures.
• Identifying, investigating, and troubleshooting potential issues, and proposing solutions to ensure project success.
• Proactively identifying opportunities for process improvement and implementing changes to increase efficiency and effectiveness.
• Serving as a subject matter expert in microbiology, offering guidance and expertise to support product development.

Qualifications

• This role requires a BS or MS degree in Microbiology or a related field, with BS and 15+ years or a MS and 12+ years of experience in the pharmaceutical industry, with 8+ years of leadership experience.
• Highly preferred skillsets include extensive knowledge of antimicrobial effectiveness testing, microbial challenge in-use studies, drug product sterility, manufacturing processes, and microbial risk assessment for facilities.
• Proven experience developing and managing release testing of drug products and environmental monitoring programs.
• Strong understanding of applicable regulations, including USP, ICH, and Ph. Eur., related to microbial testing.

Compensation and Benefits

Salary range (annually): $150,500.00 - $245,500.00. This role offers 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 country-specific benefits, please speak to your recruiter.

On-site Policy

Please be advised that at Regeneron, we believe we are most successful when we are together. For that reason, many Regeneron 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 location.

Equal Opportunity

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.

Salary and Locations

For roles 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 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.

Background Checks

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 is to verify information regarding a candidate prior to the commencement of employment (e.g., identity, right to work, educational qualifications).

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