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
- 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)
