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.

We are in search of an Associate Director, In Vivo Services who will serve as a Study Director for GLP and non-GLP studies and provide scientific leadership and management to the In Vivo Services team; ensuring the delivery of top-quality nonclinical services for clients.

Primary Responsibilities

Serve as Study Director for GLP and non-GLP studies
Study reporting, including final study reports, contributing scientist reports, documentation of in-life phase, etc.
Observation of in-life phase study procedures to ensure quality control (QC) and documentation in accordance with ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate)
Drafting of amendments, deviations, change controls, and standard operating procedures (SOPs)
You will work with Quality Assurance (QA) Unit within Franklin Biolabs to ensure compliance
Serve as the subject matter expert (SME) for all onsite audits and inspections, and the responsible party for addressing all requests and corrections from the auditor team
Support Project Management activities related to in vivo studies to ensure timely invoicing, assist with project profitability, and provide routine updates on opportunities and risks to help with forecasting

Education and Experience:

Minimum of Ph.D. degree in life sciences, biotechnology, pharmacology, or a related field required
3-5 years of direct experience in nonclinical studies, including Pharm, Biotech, and/or CRO
Experience managing studies performed under Good Laboratory Practices (21 CFR Part 58) preferred

Knowledge, Skills and Abilities:

Knowledge of regulatory compliance and agencies (USDA, 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 business.
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 Status:

Essential for Research: This position may be required to go on-site to perform their regular work functions related to continued research during periods of adjusted operations. This would not likely be required to go on-site during a company closure under normal business operations.

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) Matching
Health insurance
Dental 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)

Learn more about this Employer on their Career Site