Principal Scientist, Analytical Sciences

Upsher-Smith Laboratories•Rockville, MD

23h

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 product characterization for biologics using a variety of scientific processes and methodologies. The position works collaboratively across functions to support molecules from early- through late-stage development and commercialization, selecting experimental methods, conducting analyses, and interpreting results. It leads the product characterization group, provides analytical leadership across BPD functions and projects, and supervises and mentors direct reports.

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 staff to accomplish goals and objectives.
Extensive hands-on experience and in-depth knowledge in product characterization method development for biologics.
Experience designing and executing analytical comparability studies, supporting product and process characterization, and conducting early- and late-stage analytical activities.
Strong expertise in structure-function relationships and protein characterization methods.
Experience systematically troubleshooting analytical methods and diagnosing 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.
Ability to work successfully in a fast-paced matrix environment and adapt 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.
Experience with other protein characterization techniques, such as physicochemical methods, biophysical methods, and particle characterization.
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.
Ability to establish external collaborations and experience managing CRO vendors.
Ability to formulate and advance strategies.

Nice To Haves

Knowledge or experience in multi-attribute methods (MAM).
Strong publication and conference presentation record.

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) assessment 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, 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 information from conferences, meetings, and literature.
Maintain understanding of current FDA and ICH guidelines regarding product characterization to meet regulatory expectations.
Present scientific findings at internal and external meetings.