Principal Analytical Scientist, CMC
Company: Compass Therapeutics
Location: Boston
Posted on: April 1, 2026
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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, Attleboro , Principal Analytical Scientist, CMC, Science, Research & Development , Boston, Massachusetts