What are the responsibilities and job description for the Director, Biologics Process Development position at Pheon Therapeutics?
We are seeking an experienced and highly motivated Process Development leader to drive the development, optimization, scale-up, and technology transfer of manufacturing processes for antibody-drug conjugates (ADCs) and monoclonal antibodies (mAbs). This individual will lead cross-functional process development activities to support late-stage and commercial manufacturing while ensuring robust, scalable, and regulatory-compliant processes.
The successful candidate will possess deep expertise in upstream and/or downstream process development, conjugation technologies, analytical characterization, CMC strategy, and GMP manufacturing support. This role requires strong scientific leadership, project management, and collaboration across Research, Analytical Development, Manufacturing, Quality, Regulatory Affairs, and external CDMO partners.
Responsibilities:
Process Development
- Lead process development activities for monoclonal antibodies and antibody-drug conjugates.
- Design, optimize, and characterize upstream, downstream, purification, and formulation processes.
- Develop scalable and robust manufacturing processes suitable for clinical and commercial production.
- Identify critical process parameters (CPPs) and establish design space using Quality by Design (QbD) principles.
- Perform process characterization and risk assessments using DOE and statistical tools.
- In depth experience in cell culture process development, purification chromatography, Tangential flow filtration (TFF), and viral clearance processes
- Conduct process characterization and process validation using first principles for scale-up and GMP manufacturing along with statistical data analysis
Technology Transfer & Manufacturing Support
- Lead technology transfer to pilot plants, CDMOs, and commercial manufacturing sites.
- Identify innovative technologies to improve process robustness, productivity, and manufacturing efficiency.
- Author process descriptions, batch records, process validation protocols, and technical reports.
- Provide manufacturing support for engineering, GMP, PPQ, and commercial campaigns.
- Investigate process deviations, CAPAs, and root cause analyses.
CMC & Regulatory Support
- Contribute to CMC strategy for IND, BLA, and global regulatory submissions.
- Prepare technical documentation supporting regulatory filings.
- Support regulatory inspections and agency interactions.
Cross-Functional Leadership
- Collaborate with Analytical Development, Formulation Development, Manufacturing Sciences, Quality, Regulatory Affairs, and Supply Chain.
- Manage external collaborations with CDMOs.
Required Qualifications
- Ph.D. in Chemical Engineering, Biochemical Engineering, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related field with 10 to 15 years of industry experience
- Extensive experience in biologics process development.
- Strong expertise and hands-on experience in monoclonal antibody manufacturing and antibody-drug conjugate process development.
- Experience with process scale-up from laboratory through commercial manufacturing.
- Knowledge of GMP manufacturing and technology transfer.
- Experience supporting IND, BLA, or commercial products.
- Strong understanding of ICH, FDA, EMA, and global regulatory requirements.
- Experience working with CDMOs.