Principal Analytical Scientist, CMC

Compass Therapeutics•Boston, MA

2d•$140,000 - $188,000•Onsite

About The Position

Compass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’ scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. Our pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. We plan to advance our product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. We were founded in 2014 and are headquartered in Boston, Massachusetts. 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.

Requirements

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

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

Benefits

At Compass, we provide employees with an inclusive offering of benefits and a competitive compensation package.
We offer our employees competitive salaries, discretionary bonuses, and meaningful equity participation.
Our innovative benefits support the health and wellness of our employees; from medical, dental and vision benefits to health reimbursement arrangement, flexible spending accounts, sponsored gym membership, an employee assistance program, life insurance, and much more.
We also provide 401(k) and Roth 401(k) programs with a 6% company match, and other resources for financial wellness.
Additional benefits include commuter reimbursement, subsidized company parking, cell phone reimbursement, Summer Fridays, and substantial paid time off including a winter shut down week.
Our Mission at Compass is to develop next generation antibodies into transformative cancer therapies that improve patients’ lives.
Our Compass Core Values guide us in achieving this.
We are mission-focused and share a passion for science and creativity that help us innovate in all that we do.
Our unique community promotes authenticity, diversity of thought, and collaborative teamwork .
We invest in the growth and development of our teams and individuals through programs such as company-wide trainings, cross-functional collaboration and job shadowing, tuition reimbursement, employee recognition awards, and a comprehensive performance management cycle.
Also, our Compass Culture Committee empowers employee-organized events that celebrate wins, drive initiatives, support local philanthropy, and align with our mission and values.