Principal Scientist, Analytical Sciences

Upsher-Smith Laboratories, LLC•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 in the BioPharmaceutical Development (BPD) department. The role leads product characterization and develops analytical characterization methods for biologics using scientific methods that include mass spectrometry, chromatography, and electrophoretic techniques. The position supports programs from early through late-stage development and commercialization, selecting experimental approaches, conducting analyses, and interpreting results and conclusions in a timely manner. Working collaboratively across BPD and CMC functions, the Principal Scientist provides analytical leadership for projects, develops analytical timelines and control strategies, and supports characterization, comparability, and CQA assessments. The role also supervises and mentors Scientists and Senior Scientists, oversees relevant analytical instrumentation and procedures, and authors and reviews technical documentation. The position serves as an analytical resource for the department and project teams and presents scientific findings internally and externally.

Requirements

PhD in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or life sciences and at least 8 years of related industry experience, including 5 years in biologics; or a master’s degree in one of these fields and at least 12 years of related industry experience, including 8 years in biologics; or a bachelor’s degree in one of these fields and 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 team members 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, supporting product and process characterization, and performing 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 track record of on-time delivery.
Demonstrated ability to work in a fast-paced matrix environment, adapt to changing priorities and timelines, and collaborate across CMC functions.

Nice To Haves

Experience developing and qualifying HPLC- and CE-based methods for monoclonal antibodies and fusion proteins.
Experience with other protein-characterization techniques, including physicochemical, biophysical, and particle-characterization methods.
Knowledge 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 biologic programs.
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 early analytical 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 Critical Quality Attribute (CQA) assessments by designing and executing studies, analyzing data, and interpreting results.
Supervise operation and maintenance of relevant analytical instrumentation and procedures, including UPLC, mass spectrometry, and higher-order structure tools.
Author and review technical documentation, including SOPs, comparability plans and reports, specification justifications, and guideline documents.
Create high-performing teams and supervise, coach, and mentor direct reports to support staff development, productivity, and effectiveness.
Serve as an analytical resource for the department and project teams, sharing current scientific trends and technical developments from conferences, meetings, and literature.
Maintain understanding of current FDA and ICH guidelines for product characterization to meet regulatory expectations.
Present scientific findings at internal and external meetings.