PD Associate Scientist (Process Analytics)

360 Binney Street Cambridge, MA 02142 US

Posted: 10/16/2025 2025-10-16 2025-11-15 Employment Type: Contract Job Category: Scientific Job Number: 623219 Is job remote?: No Country: United States

Job Description

Target PR Range: 19-23/hr

• Depending on experience

Job Summary

Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces, and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers (“BiTEs”), live oncolytic viruses, and synthetic medicines.

Located in our Cambridge, MA office, the PD Associate Scientist (Process Analytics) will work to provide testing support for commercial process development and process characterization studies for clinical candidate molecules in the pivotal stage of development.

Responsibilities:

• Transition of analytical methods from our early-stage development teams to the pivotal testing laboratory. This will include interfacing with attribute sciences team leads and early stage development teams, performing method assessment / qualification, method optimization, and formatting chromatography data software methods.
• Performing high-sample volume testing by High Performance Liquid Chromatography (HPLC), Ultra High-Performance Liquid Chromatography (UHPLC), Capillary Electrophoresis (CE), and Tecan in support of Drug Substance, Drug Product, and Attribute Sciences process development teams, under prescribed timelines. Full documentation of analyses in electronic lab notebook. Performing tracking and trend analysis of method performance.
• Hand-off/transfer of testing to our Rapid Analytics teams.
• Evaluation of novel platform methodologies to improve testing efficiencies in the Process Analytics and Rapid Analytics teams.
• Performing HPLC/UHPLC and CE method qualification studies to support transfer of methods to pivotal Quality Control teams.
• Perform forced degradation studies to support product characterization, understanding of product stability and evaluation of product comparability.
• Closely collaborate with partner organizations during commercial process development, process characterization and process validation studies to support marketing applications.

Preferred Qualifications

• B.S. in Chemistry or Biochemistry
• 1–2 years of experience in a pharmaceutical/biotech analytical lab.
• Good general biochemistry laboratory skills
• Working knowledge of chromatography including HPLC, UPLC, and CE
• Working knowledge of compendial methods testing, such as Karl Fischer, Color/Clarity, and UV/VIS spectroscopy
• Strong desire to learn and interest in science
• Demonstrated proficiency in execution of test methodology following a defined procedure.
• Background in chromatography data software (Waters Empower®, Thermo, Agilent softwares) and/or automation software (Tecan®)
• Understanding of phase-appropriate GMP compliance and documentation
• Well-organized; ability to multitask, effectively plan and follow through on complex projects, and to work both independently and in teams

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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