Associate Director, Analytical Development

This position is responsible for leading the execution of Analytical characterization methods for pharmaceutical formulation, process, and method development activities. The Associate Director, Analytical Development manages individual Analytical staff members on a day-to-day basis and works with Product Development and Technical Operations team members in support of method development, method transfer, method validation, stability data generation, data summary and trend analysis. This role will also provide support in drafting test methods, Product Development SOPs, and general laboratory maintenance and operation.

• Provide leadership to Product Development Analytical staff on a day-to-day basis
• Coordinate and prioritize project activities for the direct Analytical Staff reports
• Ensure the analytical labs and equipment at the Fulton Site are properly qualified
• Develop specific and selective chromatographic methods (HPLC, UPLC and other methods for biologics /monoclonal antibodies) 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
• Oversee Research Associate(s) in the implementation of compendial monographs and procedures (USP, EP, etc.)
• Perform duties, as required, for Reference Standard programs, instrument maintenance/ calibration and Stability Programs (internal and external)
• Provide subject matter expertise, including UHPLC-RP, SEC, ion exchange, etc.
• Develop novel methods to help characterize biologics / monoclonal antibodies
• Read and record instrument data, tabulate data, and keep detailed laboratory records
• Draft Standard Operating Procedures (SOPs) for laboratory equipment operation and maintenance
• Assist in method transfer to contract service providers for late-stage and commercial products
• Participate in cross-functional project teams in support of transfer of drug product formulations and assays to pre-clinical and clinical programs
• Provide subject matter expertise to regulatory IND/NDA/BLA/MAA submissions

• Ph.D. in Analytical Chemistry, Biochemistry, or related field with 8-11 years of experience, MS degree with 10-13 years of experience, or BS degree with 12-15 years of experience
• Scientific group leadership experience
• Demonstrate understanding of modern chromatographic methods and theory, especially the chromatographic methods and theory for proteins, biologics and monoclonal antibodies
• Hands-on experience and expertise with advanced analytical instruments
• Ability to lead and mentor junior scientists/associates
• Ability to draft routine reports and maintain accurate and detailed records of work performed
• Working knowledge of Microsoft Productivity software (Excel, Word, etc.), Agilent ChemStation, and common statistical software
• Technical and Regulatory writing experience preferred
• Competencies: Written and Verbal Communications, Leadership skills, 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.