Associate Director, Analytical Sciences

Bora Biologics USA•Rockville, MD

About The Position

The Associate Director position is a technical and strategic leader in Analytical Sciences team in BioPharmaceutical 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 BioPharmaceutical Development (BPD) functions and projects to provide analytical leadership.

Requirements

PhD in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 8 years of industry related experience, including 5 years of experience in biologics; or Master’s degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or Life Sciences and a minimum of 12 years of related industry experience, including 8 years of experience in biologics; or Bachelors in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 14 years of related industry experience, including 10 years of experience in biologics
Minimum 2 years of direct people management experience including coaching and developing a team and providing motivation to accomplish goals and objectives
Extensive hands-on experience and in-depth knowledge with product characterization method development of biologics
Experience in analytical comparability study design and execution, supporting product and process characterization, and early- and late-stage analytical activities
Strong expertise in structure-function relationships and protein characterization methods.
Experience in using systematic approaches on troubleshooting of analytical methods, and in diagnosing instrument issues.
Knowledge in phase-appropriate method development strategies.
Experience in product characterization for late-phase and commercialization stages.
Strong verbal and technical writing skills
Demonstrated leadership skills, including managing, training and mentoring staff
Strong time management skills and a proven track record of on-time delivery.
Demonstrated success working in a fast-paced matrix environment and adapting to the change in priorities and timeline.
Demonstrated skills of working collaboratively and across CMC functions.
Experience in development and qualification of HPLC and CE-based methods for monoclonal antibodies and fusion proteins
Experience in other protein characterization techniques such as physicochemical methods, biophysical methods, and particle characterization.
Knowledge or experience in multi-attribute methods (MAM).
Good understanding of statistical tools and knowledge of DOE, and QbD principles
Experience in preparing analytical sections of regulatory documents such as IND, BLA and regulatory discussion documents
Strong publication and conference presentation record
Ability to formulate and advance strategies

Responsibilities

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 developability 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.
Ability to establish external collaborations and experience in CRO vendor management