Senior Director, Technical Operations - Biologics
Akebia Therapeutics
11 hours ago
Remote friendly (Cambridge, MA)
United States
Operations
Responsibilities
- Develop and execute the global CMC and manufacturing strategy for AKB-097; align technical development with regulatory and program objectives.
- Serve as CMC executive lead on the AKB-097 program team and represent Technical Operations in cross-functional decisions.
- Establish external manufacturing and lifecycle management strategies for global commercialization.
- Oversee drug substance/drug product process development (cell line development, process development, formulation development, manufacturing).
- Oversee analytical method development, product characterization, and product comparability.
- Ensure scale-up, technology transfer, process validation, and commercial readiness.
- Build and manage a network of CDMOs/strategic manufacturing partners; lead governance with external manufacturers.
- Ensure reliable clinical and commercial supply via planning, risk mitigation, and partnership with Supply Chain.
- Lead CMC regulatory strategy for INDs/BLAs and global filings; partner with Quality/Regulatory to ensure GMP compliance; support agency interactions/inspections.
- Build and lead a high-performing biologics technical development/operations organization; recruit, mentor, foster continuous improvement, and partner cross-functionally.
Qualifications
- MS or PhD in Biochemistry, Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or related field.
- 12+ years in biologics process development, product characterization, manufacturing, and technical operations.
- Proven leadership advancing biologics from development through late-stage trials and commercialization.
- Experience with product comparability (BLA support), and establishing/managing global manufacturing networks.
- Experience with monoclonal antibodies, recombinant proteins, or other complex biologics modalities.
- Deep expertise in biologics CMC (cell culture/purification, analytical, formulation, scale-up) and strong GMP/regulatory knowledge.
Compensation
- Targeted base: $245,987–$303,866. Additional benefits mentioned: health care, vision, dental, retirement, PTO, equity, and bonus/incentive programs (as applicable).
- Develop and execute the global CMC and manufacturing strategy for AKB-097; align technical development with regulatory and program objectives.
- Serve as CMC executive lead on the AKB-097 program team and represent Technical Operations in cross-functional decisions.
- Establish external manufacturing and lifecycle management strategies for global commercialization.
- Oversee drug substance/drug product process development (cell line development, process development, formulation development, manufacturing).
- Oversee analytical method development, product characterization, and product comparability.
- Ensure scale-up, technology transfer, process validation, and commercial readiness.
- Build and manage a network of CDMOs/strategic manufacturing partners; lead governance with external manufacturers.
- Ensure reliable clinical and commercial supply via planning, risk mitigation, and partnership with Supply Chain.
- Lead CMC regulatory strategy for INDs/BLAs and global filings; partner with Quality/Regulatory to ensure GMP compliance; support agency interactions/inspections.
- Build and lead a high-performing biologics technical development/operations organization; recruit, mentor, foster continuous improvement, and partner cross-functionally.
Qualifications
- MS or PhD in Biochemistry, Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or related field.
- 12+ years in biologics process development, product characterization, manufacturing, and technical operations.
- Proven leadership advancing biologics from development through late-stage trials and commercialization.
- Experience with product comparability (BLA support), and establishing/managing global manufacturing networks.
- Experience with monoclonal antibodies, recombinant proteins, or other complex biologics modalities.
- Deep expertise in biologics CMC (cell culture/purification, analytical, formulation, scale-up) and strong GMP/regulatory knowledge.
Compensation
- Targeted base: $245,987–$303,866. Additional benefits mentioned: health care, vision, dental, retirement, PTO, equity, and bonus/incentive programs (as applicable).