Job description

Director, Cell Culture Process Development
Location: Waltham, MA

Our client a company focused on developing innovative treatments for chronic dermatological diseases. Their mission is to improve patients' lives by achieving high rates of disease clearance with minimal dosing. They have secured significant funding and are advancing a portfolio of promising antibodies.

Position Overview:
We are seeking an experienced leader to oversee cell line and process development, tech transfer, and manufacturing activities. This role involves managing relationships with CDMOs, ensuring timely completion of manufacturing, and supporting regulatory submissions. The ideal candidate will be integral to our team, working in a dynamic and fast-paced environment.

Key Responsibilities:

Oversee cell line development, clone selection, and manufacturing operations.
Optimize cell culture processes for robustness, scalability, and quality.
Collaborate with internal teams and external CDMOs.
Support regulatory filings and ensure compliance with industry standards.
Conduct risk assessments and provide solutions for process development.
Travel as needed to support manufacturing activities.

Qualifications:

Advanced degree in biochemistry, biochemical engineering, biotechnology, or a related field.
Significant experience in biologics development, particularly with monoclonal antibodies.
Expertise in cell culture, media, and bioreactor optimization.
Knowledge of regulatory guidelines and compliance requirements.
Strong communication, organizational, and management skills.

Compensation:

Competitive salary and benefits package, including equity and performance-related bonuses.
Final salary will depend on experience, education, and other factors.

Job Location:

Hybrid position based in Waltham, MA, with some remote work possible. Candidates are expected to be in-office three days a week, with occasional travel required.

What We Offer:

A dynamic work environment with opportunities for professional growth.
Competitive compensation and benefits.
A chance to directly impact the development of new treatments for patients.