Associate Director, Physical/Chemical Charact

Franklin Biolabs; King of Prussia (PA); On-site; USD 150,000 - 190,000; 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 seeks an Associate Director of Physical and Chemical Characterization to lead QC processes from preclinical through clinical phases, ensuring cGxP compliance. You will develop protocols, SOPs, and release assays, working with QA and regulatory teams to maintain high standards.

On-site position in King of Prussia, PA with up to 5% travel domestically/internationally. We value collaboration, scientific excellence, and forward-thinking in a fast-paced CRO environment.

Qualifications

• Minimum BS/BA in Biology, Chemistry, or life sciences.
• 7–9 years of direct experience in analytical testing and method development.
• Experience with GLP studies (21 CFR Part 58) required.
• Formal certifications or additional education not required.

Responsibilities

• Lead a team of scientists to advance analytical characterization.
• Develop and implement analytical strategies for QC and characterization.
• Act as SME for AUC, DLS, LC-MS–based assays, ELISA, CE‑SDS, SDS‑PAGE, SEC‑MALS, pH, osmolality, and visual appearance tests.
• Provide direction and clear objectives; manage cross-functional collaborations.
• Partner with QA in investigations for deviations, CAPAs, and change controls.
• Drive process improvements to enhance efficiency and compliance.
• Monitor industry trends and regulatory developments to inform strategy.
• Communicate effectively with team, clients, vendors, and third parties.
• Work in a fast-paced environment with shifting priorities.

Skills

Team leadership

Analytical strategy

Regulatory awareness

Cross-functional collaboration

Effective communication

Education

BS/BA in Biology, Chemistry, or 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.

Associate Director, Physical/Chemical Charact

Full Time 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 a Associate Director, Physical and Chemical Characterization who will be a key technical expert and will be responsible for managing the quality control processes for various products from preclinical through early and late clinical phases, ensuring their integrity and compliance to the cGxPs. This includes managing, implementing and reviewing protocols, SOPs, release assays, and ensuring compliance with regulatory requirements. The role requires building collaborative relationships cross functionally, staying updated with industry trends and regulatory requirements, leading the team in decision‑making and problem‑solving processes, and being able to achieve department goals.

Education and Experience:

• Minimum of BS/BA degree in Biology, Chemistry, or other life sciences required.
• 7-9 years of direct experience in analytical testing and method development.
• Experience managing studies performed under Good Laboratory Practices (21 CFR Part 58).
• Formal certifications or education required: None.

Knowledge, Skills and Abilities:

• Lead a team of scientists to drive the advancement of cutting‑edge research.
• Develop and implement analytical strategies.
• Act as SME for Analytical Ultracentrifugation (AUC), Dynamic Light Scattering (DLS), LC-MS–based assays, ELISA and other plate‑based assays, Capillary Electrophoresis – SDS (CE‑SDS) and SDS‑PAGE, Size‑Exclusion Chromatography coupled with Multi‑Angle Light Scattering (SEC‑MALS), pH, osmolality, and visual appearance tests.
• Provide direction and guidance to team members, ensuring clear objectives and expectations are established and met.
• Foster a collaborative and innovative environment to meet compliance requirements.
• Monitor and analyze industry trends and developments to inform decision making and strategy development.
• Represent the company and its values in interactions with external stakeholders
• Partner with QA to act as QC lead in investigations for deviations, CAPA's, and change controls.
• Continuously seek out and implement process improvements to enhance efficiency and effectiveness.
• 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.

On‑Site:

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

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.

Vision:

• 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)