Careers
We are seeking a highly skilled and experienced Director of Protein Purification and ADC Conjugation Development to build and lead our protein purification and conjugation capabilities. This leadership role will oversee the development, optimization, and scale-up of processes for protein purification and antibody-drug conjugate (ADC) manufacturing. As a key member of our organization, you will play a pivotal role in both strategic planning and hands-on execution, driving the advancement of our biotherapeutic pipeline. This is a remote role.
Key Responsibilities:
- Lead the development, optimization, and scale-up of protein purification processes, including chromatography, filtration, and other techniques.
- Oversee the development, optimization, and technology transfer of ADC conjugation processes.
- Serve as a subject matter expert (SME) for purification and conjugation, including CDMO evaluation and selection.
- Establish and manage relationships with CDMOs and external partners to support technology transfer and production activities.
- Design and implement efficient workflows to ensure scalability and alignment with GMP requirements.
- Evaluate and integrate innovative technologies to enhance protein purification and conjugation processes.
- Collaborate cross-functionally with R&D, process development, manufacturing, and quality assurance teams to ensure project success.
- Prepare technical documentation, reports, and regulatory submissions (e.g., IND/IMPD).
- Stay informed of advancements in protein purification, bioconjugation, and ADC technologies, leveraging insights to guide strategic decisions.
- Lead the CMC team independently or with minimal supervision.
Skills & Experience
- 7 years of industry experience in protein purification, bioconjugation, or ADC development.
- Proven leadership track record, including management of teams and cross-functional collaboration.
- Technical Expertise:
- Theoretical knowledge and hands on experience with protein purification techniques, such as affinity, ion exchange, hydrophobic interaction, tangential flow filtration, as well as ADC conjugation technologies required. Experience with large scale purification and filtration required.
- Knowledge of linker chemistries, payload handling, and analytical characterization are desired.
- Experience with process development, scale-up, technology transfer and clinical manufacturing required.
- Experience with Late-stage process characterization, risk assessment, control strategy, process validation, and commercial manufacturing are desired.
- Regulatory Knowledge:
- Strong understanding of regulatory and quality standards for biologics and ADC manufacturing.
- Experience in authorizing regulatory submissions and responding to agency questions required.
- Leadership and Communication:
- Excellent leadership, organizational, and communication skills.
- A self-directed individual with a no-job-too big or too small attitude.
- Ability to work collaboratively in cross-functional teams and manage complex projects effectively.
- Experience in leading CMC team is a desired.
Required Education
- Ph.D. in Biochemistry, Chemistry, Chemical Engineering, or a related field; Master or Bachelor degree with significant industry experience will also be considered.