Associate Director, Bioanalytical Development

About Us:

SalioGen Therapeutics is developing next-generation genetic medicines for patients using its novel Gene CodingTM technology. Gene Coding is a non-viral method of integrating large or multiple whole genes into the genome at precise locations without double-strand breaks or guide RNA. SalioGen's lead programs focus on one-time treatments for Stargardt disease and cystic fibrosis. The company is also developing its Gene Coding technology for additional indications, such as other inherited retinal diseases, and to engineer CAR-T cells for cancer and autoimmune conditions. SalioGen is headquartered in Lexington, Massachusetts.

Position Summary:

SalioGen Therapeutics is seeking an Associate Director with strong hands-on experience in ligand-binding assays, including pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody (ADA) assessments, to quantify mRNAs, proteins, and antibodies against therapeutic proteins. On a day-to-day basis, you will collaborate with various departments to determine assay requirements and deadlines, ensuring the success of our projects. You will play a critical role to bolster our preclinical development efforts and assist in advancing the candidates to clinic.

Primary Responsibilities:

• Lead the assay development effort to support non-clinical studies and act as Subject Matter Expert for assays and support method validation as required.

• Aid in the method development and qualification of new assays to support preclinical projects across SalioGen's programs.

• Able to critically review and efficiently troubleshoot any assay issues.

• Manage multiple experiments, projects, and interactions simultaneously.

• Facilitate the transfer, qualification, and validation of assays to Contract Research Organization (CRO) partners, as well as assist with troubleshooting any assay-related issues with these partners.

• Interface with preclinical project teams to understand their priorities as well as aid in the interpretation of data.

• Work closely with cross-functional groups to align on projects and priorities (direct or at subteam meetings).

• Implement processes to ensure timelines are met with data and documentation quality.

• Coordinate the need of critical reagents (drug products, purified recombinant proteins etc.) either from internal sources (CMC, Protein Sciences) or external sources (CROs, Vendors).

Qualifications & Skills Required:

• Ph.D. in Chemistry, Biochemistry, Immunology, Analytical Sciences, or a related field, with at least 7 years' experience in the biotechnology or pharmaceutical industry.

• Minimum of 5-10 years of hands-on experience in Bioanalytical Method Development, qualification, validation, and sample analysis to support GLP/nGLP studies.

• Strong knowledge of Bioanalytical Assay Validation regulations (FDA, EMA guidance)

• Expertise in Ligand Binding Assay Methods (ELISA, MSD, Gyrolabs, Simoa etc.)

• Experienced with critical reagent characterization and life cycle management.

• Working knowledge of skills in PCR methods, LCMS, Flow cytometry are highly desirable.

• Extensive expertise in Bioanalytical method development, qualification, validation to support nonclinical programs from conception to first in human.

• Demonstrated ability to lead cross-functional teams and work collaboratively.

• Proven track record of scientific publications and presentations, with a reputation as a thought leader in the field.

• Strong project management, organization, and attention to detail; ability to handle multiple projects in a fast-paced environment.