Director of CMC

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.
We are seeking an experienced and driven Associate Director/Director of CMC with a focus in Analytical Development and Process/Analytical Control Strategy, reporting to our VP & Head of CMC. This position will lead analytical development activities and implementation of analytical strategies for our clinical-stage antibody assets. The ideal candidate will have a strong background in analytical methods development and/or in downstream process development, validation, and technology transfer.
This position is fully in-person and reports onsite to our office in Boston, MA.
Responsibilities:

• Manage analytical development processes across all three of our clinical-stage antibody assets / drug candidates in support of commercialization.
• Develop and lead phase-appropriate process and analytical control strategy including establishment of quality target product profile (QTPP), assessment of critical quality attributes (CQAs), justification of specifications and establishment of test methods for antibody programs.
• Oversee analytical technical activities at CMO/CDMOs and contract laboratories supporting process development, product release and stability, product characterization, and process performance qualification including drug substance and drug product technology transfer.
• Oversight of extended characterization studies of drug substances, drug products, and associated impurities, directing comparability strategies for process changes.
• Responsible for nonGMP/GMP stability programs for all three clinical-stage assets, following ICH stability requirements for setting shelf life/expiry.
• Lead authoring of CMC analytical dossier and relevant sections of regulatory filings for regulatory submissions (IND, IMPD, PAS, BLA, etc.), address queries from health authorities, engage in face-to-face FDA inspection, Type-C meetings.
• Expertly present to C-suite leadership, providing critical insights and recommendations to support company decisions.

Qualifications:

• PhD with 5+ years of relevant experience, or 10+ years of experience with a Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field; equivalent advanced degrees considered.
• Proven relevant experience with biologics/antibodies in analytical development within the biopharmaceutical/biotech industry is required.
• Expertise in leading CMC projects, developing and validating analytical methods for antibodies/bispecific antibodies per ICH and regulatory guidelines.
• Proven track record of successful technology transfers.
• Expert working knowledge with late-stage regulatory requirements and regulations governing the US and globally (FDA, ICH, etc.) pertaining to analytical development, including IND- and BLA-enabling regulatory writing.
• Ability to apply principles of Quality by Design, including development of critical quality attributes, phase-appropriate method validation strategies, and development of an analytical control strategy in support of PPQ validation.
• Experience maintaining effective relationships with internal and external stakeholders, including collaborations with external partners.
• Demonstrated success in problem solving, task management, and effective communication in a fast-paced collaborative work environment.
• Comfortable working independently and completing multiple complex project objectives simultaneously.

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.
 

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