Principal Scientist, Analytical Sciences

Bora Pharmaceuticals•Rockville, MD

2d•$142,000 - $200,000

About The Position

The Principal Scientist, Analytical Sciences is a technical and strategic leader on the Analytical Sciences team within the BioPharmaceutical Development (BPD) department. The role develops analytical characterization methods and performs characterization of biologics using a range of scientific processes and methodologies. The position works collaboratively across functions to support molecules from early through late-stage development and commercialization, selecting experimental methodologies, conducting analyses, and delivering timely interpretations and conclusions. The role also leads the product characterization group, supervises and mentors direct reports, and provides analytical leadership across BPD functions and projects. The position leads product characterization and Critical Quality Attribute (CQA) assessment, analytical comparability evaluations, and development of analytical control strategies in accordance with ICH and other regulatory guidelines. It represents Analytical Sciences on CMC teams, coordinates analytical deliverables with project timelines, supports regulatory-ready documentation, and ensures that characterization work meets current FDA and ICH expectations. The role supervises Scientists and Senior Scientists and is responsible for coaching, mentoring, and developing staff.

Requirements

PhD in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or life sciences with at least 8 years of related industry experience, including 5 years in biologics; or a Master’s degree in one of these fields with at least 12 years of related industry experience, including 8 years in biologics; or a Bachelor’s degree in one of these fields with at least 14 years of related industry experience, including 10 years in biologics.
At least 2 years of direct people-management experience, including coaching and developing a team and motivating staff to accomplish goals and objectives.
Extensive hands-on experience and in-depth knowledge of biologics product-characterization method development.
Experience designing and executing analytical comparability studies and supporting product and process characterization and early- and late-stage analytical activities.
Strong expertise in structure-function relationships and protein-characterization methods.
Experience using systematic approaches to troubleshoot analytical methods and diagnose instrument issues.
Knowledge of phase-appropriate method-development strategies.
Experience in product characterization for late-phase and commercialization stages.
Strong verbal communication and technical writing skills.
Demonstrated leadership skills, including managing, training, and mentoring staff.
Strong time-management skills and a proven record of on-time delivery.
Demonstrated success working in a fast-paced matrix environment and adapting to changing priorities and timelines.
Demonstrated ability to collaborate across CMC functions.
Experience developing and qualifying HPLC- and CE-based methods for monoclonal antibodies and fusion proteins.

Nice To Haves

Experience with other protein-characterization techniques, including physicochemical methods, biophysical methods, and particle characterization.
Knowledge of or experience with multi-attribute methods (MAM).
Good understanding of statistical tools and knowledge of DOE and QbD principles.
Experience preparing analytical sections of regulatory documents such as INDs, BLAs, and regulatory discussion documents.
Strong publication and conference-presentation record.
Ability to establish external collaborations and experience managing CRO vendors.
Ability to formulate and advance strategies.

Responsibilities

Lead the product characterization group and develop analytical characterization methods, including mass spectrometry, chromatography, and electrophoretic methods for biologics.
Provide hands-on guidance for characterization testing, including reference standard material, in-process samples, and comparability studies.
Represent Analytical Sciences on CMC teams; generate analytical development timelines integrated with CMC project timelines and ensure timely completion of analytical deliverables.
Collaborate with CMC teams to develop analytical control strategies in accordance with ICH and other regulatory guidelines.
Perform analytical early developability assessments to identify major molecule liabilities.
Lead analytical comparability evaluations of product quality and stability to support drug substance and drug product process changes.
Lead product characterization and CQA assessments by designing and executing studies, analyzing data, and interpreting results.
Supervise the operation and maintenance of relevant analytical instrumentation and procedures.
Author and review technical documentation, including SOPs, comparability plans and reports, specification justifications, and guideline documents.
Create high-performing teams and supervise direct reports; coach and mentor staff to support development and maximize productivity and effectiveness.
Serve as an analytical resource for the department and project teams, sharing current scientific trends and technical developments from conferences, local meetings, and literature.
Ensure understanding of current FDA and ICH guidelines regarding product characterization and regulatory expectations.
Present scientific findings at internal and external meetings.