Senior Manager, Study Management

Franklin Biolabs; King of Prussia (PA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

401(k)

401(k) Matching

Health insurance

Vision insurance

Health Savings Account and Flexible Sp

Paid Time-Off

Company Paid Holidays

Personal Floating Holidays

Short-Term and Long-Term Disability

Life and AD&D insurance (Group & Vol)

Job summary

Franklin Biolabs in King of Prussia, PA, is seeking a Senior Manager, Study Management to lead a team of Study Scientists and oversee animal study activities to ensure compliance with USDA, DEA, OLAW, GLP, and AAALAC standards. The role emphasizes mentoring staff, SOP development, and cross-functional study coordination.

The position focuses on timely, high-quality data generation in a fast-paced CRO setting, with travel as needed and on-site responsibilities at Discovery Labs.

Qualifications

• Minimum of Associates Degree with AALAS accreditation or BS/BA in Life Sciences or related field.
• 5+ years direct experience in the laboratory animal field (10+ years preferred).
• AALAS LATG certification preferred; accreditation if Associates only.
• Knowledge of regulatory compliance and agencies (USDA, DEA, OLAW, GLP, AAALAC).

Responsibilities

• Directly supervise a dynamic team of Study Scientists and provide daily oversight.
• Ensure staff are trained in study techniques, animal models, and regulatory practices.
• Develop and revise SOPs; improve processes for efficiency and quality.
• Oversee study sample collection and delivery with QC oversight and ALCOA.
• Review and edit study protocols for clarity, feasibility and compliance.
• Collaborate with other teams to ensure study completion and regulatory audits.
• Participate in regulatory audits and inspections as SME as required.

Skills

Regulatory compliance

Team leadership

Written communication

Cross-functional collaboration

Education

Associates degree with AALAS

BS/BA in Life Sciences

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Manager, Study Management

Full Time Direct King of Prussia, PA, US

Franklin Biolabs emerges from the esteemed legacy of Dr. Jim Wilson's laboratory, a beacon of innovation in vector technology for over three decades. Building on this rich heritage, Franklin Biolabs is poised to redefine the landscape of the global genetic medicines industry. As a Contract Research Organization (CRO), Franklin Biolabs offers a comprehensive suite of services spanning from discovery through clinical manufacturing. Our goal is to empower our partners by providing unparalleled solutions that drive the advancement of genetic medicines. Leveraging decades of expertise and a commitment to excellence, we bridge the gap between groundbreaking research and ensuring that transformative therapies reach those who need them most.

Franklin Biolabs, Inc. is in search of aSenior Manager, Study Management, who has responsibility for the management of study-related activities conducted by the In Vivo Services team. The Senior Manager, Study Management, will ensure that all animal-related study activities are fully supported in a timely, efficient, and effective manner. The Senior Manager, Study Management will ensure that operations are conducted in accordance with USDA, DEA, OLAW, GLP, and AAALAC standards.

Specific responsibilities include, but are not limited to:

• Directly supervise a dynamic team of Study Scientists, providing daily oversight, mentorship, and performance management
• Ensure staff are trained in study techniques, animal models, and regulatory practices, to ensure your team is well-prepared to conduct studies in compliance with established protocols and regulatory standards
• Develop and revise operational procedures and methods for study support, including contribute to process improvement initiatives by helping to develop and refine internal procedures aimed at increasing efficiency, consistency, and scientific quality
• Study sample collection and delivery for non-GLP and GLP studies with managerial / quality control (QC) oversight and ensuring compliance with ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate)
• Review and edit study protocols to ensure clarity, feasibility, and compliance
• Collaborate with other teams within Franklin Biolabs to ensure study completion
• Develop and track reviews of standard operating procedures (SOPs) to ensure compliance
• Participation in regulatory audits and inspections as a subject matter expert (SME) as required

Education and Experience

• Minimum of Associates Degree with AALAS accreditation or BS/BA degree in Life Sciences, Animal Science or related field required.
• 5+ years of direct experience in the laboratory animal field (10+ years preferred)

Certifications or Licenses:

• AALAS Certification at LATG level or higher preferred
• AALAS Accreditation required if individual holds Associates Degree only

Knowledge, Skills and Abilities:

• Knowledge of regulatory compliance and agencies (USDA, DEA, OLAW, GLP, AAALAC).
• Knowledge of animal care and use and regulatory expectations.
• Strong analytical and organizational skills.
• Strong interpersonal skills with the ability to influence and negotiate through conflicting situations.
• Self-directed individual with the ability to perform in a fast-paced environment with limited direction, competing priorities under tight deadlines.
• Ability to communicate clearly and effectively, both verbally and in writing, to interact with team members, clients, vendors and other third parties.
• Ability to collaborate effectively with individuals across various disciplines to ensure alignment.
• Ability to use digital communication tools (video conferencing, chat platforms etc.) to effectively collaborate with team members in hybrid and remote settings.

Travel:

• Ability to travel domestically and/or internationally up to 5% of the time, depending on the needs of the project, the client and the company.
• Ability to accommodate evening, overnight or weekend travel, including potential extended trips to attend training, meetings, conduct fieldwork, or meet with clients.

On-Site:

• This position requires full-time on-site presence at our Discovery Labs location.

Immunizations and Screenings:

• This position will require working with animals (e.g. Nonhuman Primates, Rabbits, Rats, Mice).
• This position requires access to lab spaces.
• This position will require access to lab animal spaces.
• Essential for Closure: This position may be required to go on-site during company closures to sustain the life and care of animals/biological materials. Examples of company closures include snow days, special shutdowns, etc.

Vision:

• Ability to distinguish between different colors (normal color vision).
• Ability to see clearly at various distances.
• Adequate near vision for reading documents or lab equipment.
• Ability to focus and maintain concentration in tasks for extended periods.
• Ability to work in environments with varying light conditions.

Company Benefits:

• 401(k)
• 401(k) Matching
• Health insurance
• Vision insurance
• Health Savings Account and Flexible Spending Account
• Paid Time-Off
• Company Paid Holidays
• Personal Floating Holidays
• Short-Term and Long-Term Disability
• Life and AD&D insurance (Group & Voluntary)