Associate Director

BioPhase Solutions

San Diego, CA

$180,000 to $200,000 Yearly
Full-Time

Job Description

Associate Director, Analytical Development

We are looking for an Associate Director to join our skilled, dynamic, and teamwork-driven group. This role will mainly focus on creating and overseeing analytical strategies for the biophysical characterization and advancement of lipid nanoparticles within the company's portfolio. Collaborating closely with the technology development and research units, this role will enhance our understanding of processes and products, facilitate the platform's growth, and spearhead product research efforts.

Pay Range: $180,000-$200,000 per year

Responsibilities:

Lead internal development of novel analytical methods to characterize LNP components and products, including HPLC, LC-MS, CE, DLS, ELISA, and plate-based assays.
Lead phase-appropriate buildout of analytical methods for extended characterization, product release, stability, comparability, and compatibility.
Support in-process analytics, process optimization, and new technology development activities
Manage internal routine and non-routine analysis of lipid, mRNA, antibody, antibody conjugates, and targeted LNP drug products
Support internal stability programs
Support method transfer to external CDMOs
Lead analytical investigations into deviations and OOS results
Draft technical reports and analytical sections for regulatory filings
Manage and develop a team of scientists and associates

Requirements:

Qualified candidates should have an MS or Ph.D. degree and five or more years of relevant experience. This should include at least three years of experience managing teams directly and overseeing a specific functional area.
A degree in Biochemistry, Chemistry, Bioengineering, or a related field with a proven track record developing analytical methods for biologicals (LNPs, mRNA, viral vectors, antibodies, etc.) is strongly preferred.
Deep technical expertise in the application of current analytical methods for the characterization of lipid excipients, antibodies, mRNA, and LNP therapeutics
Demonstrated familiarity with international regulatory standards and application to analytical methodologies.
Proven involvement in stability programs to ensure product integrity and efficacy.
Strong proficiency in composing comprehensive reports and analytical sections for submission in regulatory documents such as IND/IMPD and BLA/MAA, with a marked preference for candidates possessing this experience.