Associate Director, Analytical Sciences

About Bora:
Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from First‑in‑Human through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purpose‑built for commercialization. Our inspection‑proven, bi‑coastal U.S. manufacturing platform and integrated development center provide the infrastructure, regulatory discipline, and operational precision required for sustained global market supply.

Job Summary:

The Associate Director position is a technical and strategic leader in Analytical Sciences team in Bio Pharmaceutical Development (BPD) department. This role will be responsible for developing analytical characterization methods and performing product characterization for biologics using a variety of scientific processes and methodology. This individual will work closely with other functions in a result‑driven, collaborative environment to support early to late‑stage development of molecules leading to commercialization.

He/she will be responsible for selecting experimental methodology, carrying out the analyses and providing interpretations and conclusions in a timely fashion. The Associate Director will supervise and mentor direct reports and work across Bio Pharmaceutical Development (BPD) functions and projects to provide analytical leadership.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Leads the product characterization group and develop analytical characterization methods including, but not limited to, mass spectrometry, chromatography, and electrophoretic methods for biologic programs. Provides hands‑on guidance on characterization testing support, including reference standard material, in‑process samples, and comparability studies. Represents Analytical Sciences function in CMC teams.

Generate analytical development timelines that integrate with CMC project timelines and ensure timely completion of all analytical deliverables. Collaborates with CMC team to develop analytical control strategy in accordance with ICH and other regulatory guidelines for the pipeline molecules. Perform analytical early develop ability assessment to identify major molecule liabilities. Leads analytical comparability evaluations of product quality and stability to support drug substance and drug product process changes.

Leads product characterization and Critical Quality Attribute (CQA) assessment by designing and executing studies, analyzing data and interpreting results. Supervises the operation and maintenance of relevant analytical instrumentation (e.g. UPLC, MS, HOS tools etc.) and procedures. Authors and reviews technical documentation, including SOP, comparability plans and reports, justification of specification, and guideline documents Creates high‑performing teams and supervise direct reports.

Provide coaching and mentoring to ensure staff development and feedback to maximize productivity and effectiveness. Serves as an analytical resource for the department and project teams, proactively keeping colleagues updated with current scientific trends and technical aspects from conferences, local meetings, and literatures. Ensures understanding of current FDA and ICH guidelines regarding product characterization to meet regulatory expectations Presents scientific findings at internal and external meetings.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time which…