Associate Principal Scientist, Analytical Development

We are seeking a highly skilled and experienced Associate Principal Scientist, Analytical Development to lead characterization work with a specific focus on monoclonal antibodies (mAb) and large molecules. As a key member of our research and development team, the successful candidate will drive analytical strategies, develop robust methods, and contribute to the advancement of our Xeriject technology. The Associate Principal Scientist, Analytical Development will work very closely with Formulation and Product Development team members in support of product development and characterization work. This role is responsible for assisting in the execution of analytical characterization methods for pharmaceutical formulation, process, and method development activities. This role will also provide support in drafting test methods, routine analysis, SOP’s and general laboratory maintenance and operation. The Associate Principal Scientist also assists the CMC department in Quality by Design aspects related to developing the Quality Technical Product Profile and associated workstreams.

• Provide analytical mentorship and manage a team of junior scientists of the analytical group on a day-to-day basis to ensure successful execution of projects and professional development.
• Provide strategic leadership to the analytical characterization group, guiding scientific direction and fostering a collaborative and innovative work environment.
• Design, develop, and optimize analytical methods for the characterization of mAbs and large molecules, ensuring compliance with industry standards and regulatory requirements.
• Implement cutting-edge technologies to enhance analytical capabilities.
• Oversee and maintain state-of-the-art analytical instrumentation relevant to mAb and large molecule characterization, such as mass spectrometry, capillary electrophoresis (CE), SEM, chromatography, and spectroscopy.
• Lead development of specific and selective methods (Peptide mapping, Protein concentration, Bioassay, Aggregation, Charge Variants, Subvisible particles and other methods for biologics) for use in characterizing prototype pharmaceutical formulations.
• Participate in the development of other stability-indicating analytical methods needed to characterize a drug product during the development stage.
• Collaborate with Pharmaceutical Development Scientists to design adequate stability/ characterization protocols for new products for toxicology, bioavailability, and early-stage clinical support.
• Lead data analysis efforts, interpret results, and provide clear and comprehensive reports to internal stakeholders and regulatory authorities.
• Perform duties, as required, for formulation support, stability programs, instrument maintenance/ calibration and method qualification/validation.
• Configure and operate laboratory instruments, including LCMS-TOF, UHPLC, CE, UV, SEM, FlowCam, MALs, DLS, CAD, CE-SDS, Karl Fischer Titrator, etc.
• Draft Test Methods, Protocols, Reports and SOPs for equipment operation and maintenance
• Participate in cross-functional project teams in support of transfer of drug product formulations and assays to pre-clinical and clinical programs.
• Assist in Quality by Design work related to Quality Attributes and the Quality Technical Product Profile
• Provide subject matter expertise to regulatory IND/NDA/BLA/MAA submissions.

Skills and Qualifications: 

• Ph.D. in Analytical Chemistry, Biochemistry, or related field with 5-8 years of industry experience or MS degree with 7-10 years of industry experience, or BS degree with 9-12 years of industry experience.
• Proven experience in the biopharmaceutical industry with a focus on mAb and large molecule characterization.
• In-depth knowledge of regulatory requirements for analytical characterization of biologics.
• Demonstrate understanding of modern characterization methods and theory, especially for mAb, proteins and Biologics.
• Hands on experience and expertise with Mass Spectroscopic instrumentation required.
• Ability to lead and mentor junior scientists/associates.
• Working knowledge of Microsoft Productivity software (Excel, Word, etc.), Agilent OpenLab and common statistical software like JMP.
• Technical and Regulatory writing experience preferred.
• Competencies:  Written and Verbal Communications, Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Professionalism

Working Conditions: 

• Must be able to stand for extended periods of time.
• Must be able to lift 25 lbs. or more.
• Adequate vision (corrected or uncorrected) to read fine instruments such as calipers, instrument displays, etc. and perform visual inspection for defects.
• Position works with potentially hazardous chemicals and active pharmaceutical ingredients. May require periodic evening and weekend work, as necessary, to meet company deadlines.
• Position may include periodic travel (domestic and international). Travel Amount varies based on assignments, not anticipated to be more than 25% of the time.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law.  It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.