Associate Director of CMC, Formulation

Company: Taylor Strategy Partners
Location: Bothell
Posted on: May 9, 2025

Job Description:

Interested in joining a clinical-stage biotechnology company focused on bringing new generation adjuvanted subunit vaccines to market? We combine excellence in protein and adjuvant biology to create vaccines of global importance.Curevo Vaccine is dedicated to developing next-generation vaccines that bring effectiveness, safety, tolerability, and advanced production capabilities to market-quickly and efficiently. We have assembled a multidisciplinary team of dedicated professionals and scientific advisors who are experts in immunology, protein science, adjuvant technology, and clinical trial and regulatory operations to expedite vaccine candidates to market.Reduce the burden of infectious disease with us. Join our team.Associate Director of CMC, FormulationLocation: Bothell, WA, United StatesDate Updated: May 7, 2025Job ID: 9429Seeking an experienced Associate Director of CMC, Formulation to join the Curevo team. The ideal candidate will play a crucial role in supporting our product development and commercialization efforts, including developing and implementing CMC strategies, ensuring regulatory compliance, leading cross-functional teams, and managing resources and timelines to achieve project milestones. This role offers substantial opportunities for personal growth and increased responsibility within our dynamic environment, collaborating with senior leadership to address quality challenges and drive improvements.KEY ROLES AND RESPONSIBILITIES

• Develop and implement CMC strategies to support product development and commercialization.
• Ensure compliance with regulatory requirements.
• Lead process development/improvement to reduce complexity and enhance efficiency and compliance.
• Oversee cGMP manufacturing operations; possess extensive knowledge of historical CMC information for process improvement. Address gaps and risks related to the CMC process. Escalate critical issues as needed. Review and approve controlled documents.
• Lead cross-functional teams, managing resources and timelines to achieve project milestones. Drive technical improvements and address challenges.
• Collaborate with QA/QC to ensure proper document controls for deviations, change control, CAPA, and SOPs.
• Coordinate with RA and CDMOs for regulatory filings and health authority inspections.
• Supervise and mentor junior staff, fostering a collaborative work environment.REQUIRED QUALIFICATIONS
• BA/BS in science.
• 8+ years of experience in CMC or related field.
• Strong technical background in protein formulation for clinical and commercial products.
• Robust knowledge of regulatory compliance in drug formulation development.
• Extensive experience in CMC leadership roles.
• Strong strategic and analytical thinking skills.PREFERRED QUALIFICATIONS
• MS or PhD in chemistry, biochemistry, or related fields.
• Experience with emulsion formulation development, such as oil/water or LNP.
• Experience with protein formulation development and scale-up.
• Experience with coformulations, such as protein + emulsion.KNOWLEDGE, SKILLS, AND ABILITIES
• Excellent communication and collaboration skills both internally and externally.
• Demonstrated leadership and a history of fostering teamwork, collaboration, and communication.
• Strong technical skills, including statistical analysis, to overcome technical challenges.
• Strong leadership and interpersonal skills, with the ability to manage relationships and make high-level decisions.
• Ability to provide visionary leadership and mentorship.PHYSICAL DEMANDSRequires ability to use hands and fingers for handling and manipulating objects, occasional standing, walking, reaching, climbing, stooping, kneeling, crouching, or crawling. Capable of reading and typing for extended periods, with vision abilities including close vision. May need to lift up to 25 lbs occasionally.WORK ENVIRONMENTProfessional office environment; routine use of standard office equipment.Curevo offers a comprehensive compensation package, including a salary range of $170,000 to $190,000, discretionary bonuses, equity awards, health benefits, flexible spending and health savings accounts, life and LTD insurance, 401(k) with match, and other benefits. We promote diversity and inclusion and are an equal opportunity employer.About Curevo Vaccine: We are a biotech company developing vaccines for unmet needs, aiming to bring a safer, effective shingles vaccine to market with rapid global availability.
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Keywords: Taylor Strategy Partners, Federal Way , Associate Director of CMC, Formulation, Executive , Bothell, Washington