Principal Analytical Scientist, CMC

Company: Compass Therapeutics
Location: Boston
Posted on: April 1, 2026

Job Description:

Compass Therapeutics, Inc. was founded in 2014 and is headquartered in Boston, MA. We are a clinical-stage, oncology-focused biopharmaceutical company discovering and developing proprietary antibody-based therapeutics to treat multiple diseases. Our scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. We have a robust pipeline of novel product candidates designed to target multiple key biological pathways to drive an effective anti-tumor response, including angiogenesis modulation, immune activation within the tumor microenvironment, and reduction of tumor-driven immunosuppression. We are advancing our discovery candidates through clinical development to commercial-stage assets. For more information, visit www.compasstherapeutics.com . Our CMC team is seeking a highly motivated and hands-on Principal Analytical Scientist, reporting to our Director of Analytical Development. The ideal candidate will have a proven track record as a key analytical lead for monoclonal antibody programs and desires to be part of a fast paced, collaborative team. This position reports onsite a minimum of 4 days/week to our office in Brighton, MA. Responsibilities: • Lead analytical development processes, support CMC strategies, and manage the execution of CMC activities at CMO/CDMO partners across all of our clinical-stage antibody assets and drug candidates in support of commercialization • Ensure that Compass CMC department goals are on track to reach milestones within established timelines, while adhering to quality standards and applicable regulations • Manage the external day-to-day development, optimization, qualification, and validation of GMP analytical methods used for release, stability, and characterization of antibody products • Accountable for method development, analytical activities and control strategy supporting drug substance (DS) and drug product (DP) release and stability testing; including quality control (QC) activities and troubleshooting • Manage the successful transfer of analytical methods to external partners, providing hands-on technical support and troubleshooting to ensure reliable execution of QC testing • Develop and lead phase?appropriate analytical control strategy including assessment of critical quality attributes (CQAs), justification of specifications and establishment of test methods for early-stage programs • Responsible for managing the lifecycle of NonGMP/GMP stability studies across various phases following ICH stability requirements for setting shelf life/expiry; from initial pull schedules to final testing and disposal • Summarize stability data to help establish self-life specifications and re-test periods based on statistical trends and regulatory requirements, including IND and BLA • Ensure all analytical data and documentation adhere to GxP and global regulatory standards (e.g., GLP/GMP, FDA, EMA, ICH) • Author and review CMC sections of regulatory filings (INDs, BLAs) related to analytical methods, specifications, and stability data • Foster strong effective relationships and liaise with internal and external stakeholders; including with cross-functional teams such as Process Development, Quality Assurance, and Regulatory Affairs Qualifications: • PhD in Analytical Chemistry, Biochemistry, Protein Science, or a related discipline with 8 years of experience, or a BS/MS in life sciences with 12 years, of analytical development in the biotech industry • Prior experience working in or directly managing a CDMO QC laboratory environment; ability to develop and implement analytical control strategies • Extensive experience leading analytical CMC activities, must include method development, qualification/validation for large molecule biologic(s); preferred experience with bispecific antibodies • Deep technical expertise in protein characterization, quality control (QC) testing, and regulatory expectations for biologics • Demonstrated problem solving and leadership skills; proven success effectively leading project matrix teams internally and externally, and managing external CDMOs • Demonstrated expertise applying analytical techniques for protein analysis, including binding ELISAs, chromatographic purity assays, cell-based potency assays, extended characterization, routine compendial assays, and analytical comparability in support of commercialization • Experience identifying critical risks, ability to provide appropriate solutions and mitigate risks; strong work principles and ethical standards are required • Excellent understanding of cGMP requirements, ICH (Q2, Q6B) and regulatory guidelines as applicable, experience authoring CMC regulatory documents is a plus • Strong attention to detail with the ability to balance multiple project objectives in a fast-paced, collaborative work environment • Excellent written and verbal communication skills, with the ability to clearly articulate complex analytical concepts and data to diverse audiences • This position allows for development opportunities across CMC functional areas as interested • This position may require up to 10% travel Base Salary Range in Job Post $140,000 - $188,000 USD Our mission is to develop next generation antibodies into transformative cancer therapies that improve patients’ lives. We built our core values from the employees up and each and every one of us is essential to achieving our mission. We are mission-focused, share a passion for science and creativity that help us innovate in all that we do. Our unique culture and community promotes authenticity, diversity of thought, and collaborative teamwork . Compass provides employees with a comprehensive and market-leading compensation and benefits package. Our compensation package includes a base salary, discretionary bonus, and meaningful equity participation for every employee. Our innovative benefits offerings support holistic employee health and wellness - from subsidized medical, dental and vision premiums to health reimbursement arrangement, flexible spending accounts, gym membership, employee assistance program, life insurance, and much more. We also offer 401(k) and Roth 401(k) programs with a 6% company match. Additional benefits include company parking, commuter reimbursement, and substantial vacation and leave policies, including summer Fridays, and a winter shut down week. Beyond traditional benefits, we invest in the growth and development of our teams and individuals through programs such as company-wide training, tuition and training reimbursement, recognition awards, and comprehensive performance management. With our Compass Culture Committee, we grow and preserve our culture through: events that build camaraderie and celebrate wins both large and small, diverse employee-driven initiatives, participation in charitable causes, and other programs that align with our values.

Keywords: Compass Therapeutics, Warwick , Principal Analytical Scientist, CMC, Science, Research & Development , Boston, Rhode Island