About this role
Pheon Therapeu,cs | Director / Senior Director, Biologics Process Development
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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
o Lead process development ac,vi,es for monoclonal an,bodies and an,body-drug
conjugates.
o Design, op,mize, and characterize upstream, downstream, purifica,on, and formula,on
processes.
o Develop scalable and robust manufacturing processes suitable for clinical and commercial
o
produc,on.
Iden,fy cri,cal process parameters (CPPs) and establish design space using Quality by
Design (QbD) principles.
o Perform process characteriza,on and risk assessments using DOE and sta,s,cal tools.
o
In depth experience in cell culture process development, purifica,on chromatography,
Tangen,al flow filtra,on (TFF), and viral clearance processes
o Conduct process characteriza,on and process valida,on using first principles for scale-up
and GMP manufacturing along with sta,s,cal data analysis
- ✓ Technology Transfer & Manufacturing Support
o Lead technology transfer to pilot plants, CDMOs, and commercial manufacturing sites.
o
Iden,fy innova,ve technologies to improve process robustness, produc,vity, and
manufacturing efficiency.
o Author process descrip,ons, batch records, process valida,on protocols, and technical
reports.
o Provide manufacturing support for engineering, GMP, PPQ, and commercial campaigns.
o
Inves,gate process devia,ons, CAPAs, and root cause analyses.
- ✓ CMC & Regulatory Support
o Contribute to CMC strategy for IND, BLA, and global regulatory submissions.
o Prepare technical documenta,on suppor,ng regulatory filings.
o Support regulatory inspec,ons and agency interac,ons.
- ✓ Cross-Func,onal Leadership
o Collaborate with Analy,cal Development, Formula,on Development, Manufacturing
Sciences, Quality, Regulatory Affairs, and Supply Chain.
o Manage external collabora,ons with CDMOs.
Required Qualifica,ons
- ✓ Ph.D. in Chemical Engineering, Biochemical Engineering, Biochemistry, Biotechnology,
Pharmaceu,cal Sciences, or related field with 10 to 15+ years of industry experience
- ✓ Extensive experience in biologics process development.
- ✓ Strong exper,se and hands-on experience in monoclonal an,body manufacturing and an,body-
drug conjugate process development.
- ✓ Experience with process scale-up from laboratory through commercial manufacturing.
- ✓ Knowledge of GMP manufacturing and technology transfer.
- ✓ Experience suppor,ng IND, BLA, or commercial products.
- ✓ Strong understanding of ICH, FDA, EMA, and global regulatory requirements.
- ✓ Experience working with CDMOs.