Senior Director, Technical Operations - Biologics
Akebia Therapeutics
2 months ago
Remote friendly (Cambridge, MA)
United States
Operations
Responsibilities
- Develop and execute the global CMC and manufacturing strategy for AKB-097, aligning technical development with regulatory and program objectives.
- Serve as the CMC executive lead on the AKB-097 program team, representing Technical Operations in cross-functional decision making.
- Establish long-term external manufacturing and lifecycle management strategies supporting global commercialization.
- Provide technical and strategic oversight for drug substance and drug product process development (including cell line development, process development, formulation development, and manufacturing).
- Oversee development of robust analytical methods and product characterization, including product comparability assessments.
- Ensure successful scale-up, technology transfer, process validation, and commercial readiness.
- Build and manage a network of CDMOs and strategic manufacturing partners supporting biologics development and manufacturing.
- Lead governance structures and strategic partnerships with external manufacturers.
- Ensure reliable clinical and commercial supply through effective planning, risk mitigation, and partnership with Supply Chain.
- Provide leadership for CMC regulatory strategy supporting INDs, BLAs, and global regulatory filings.
- Partner with Quality and Regulatory Affairs to ensure global compliance with GMP and regulatory requirements.
- Support regulatory agency interactions, inspections, and CMC submission strategy.
- Build and lead a high-performing biologics technical development and operations organization; recruit, develop, and mentor senior leaders.
- Foster a culture of scientific excellence, operational discipline, and continuous improvement.
- Partner with R&D, Clinical Development, Regulatory Affairs, Quality, Supply Chain, and Commercial teams to ensure integrated development and launch readiness.
- Contribute to portfolio planning and corporate strategy discussions related to biologics development and manufacturing.
Qualifications / Required Skills
- MS or PhD in Biochemistry, Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline.
- 12+ years of progressive experience in biologics process development, product characterization, manufacturing, and technical operations within the biotechnology industry.
- Demonstrated leadership advancing biologic therapeutics from development through late-stage clinical trials and commercialization.
- Experience leading product comparability studies supporting BLA submissions and commercial launch preparation.
- Experience establishing and managing global biologics manufacturing networks.
- Experience with monoclonal antibodies, recombinant proteins, or other complex biologics modalities.
- Deep expertise in biologics CMC development, including cell culture and purification development, analytical development, formulation development, and manufacturing scale-up.
- Strong knowledge of GMP requirements and global regulatory expectations for biologics.
- Significant experience contributing to regulatory submissions (IND, BLA, or equivalent), including product comparability assessments.
- Proven ability to lead complex development programs and organizations in a fast-paced biotechnology environment.
- Strong strategic thinking, executive communication, and stakeholder management skills.
- Demonstrated ability to build high-performing teams and external partnerships.
Compensation / Benefits
- Targeted Base: $245,987 - $303,866.
- Regular employees may be eligible for a corporate bonus program or incentive compensation program (if applicable), as well as equity.
- Additional benefits include health care, vision, dental, retirement, PTO, etc.
- Develop and execute the global CMC and manufacturing strategy for AKB-097, aligning technical development with regulatory and program objectives.
- Serve as the CMC executive lead on the AKB-097 program team, representing Technical Operations in cross-functional decision making.
- Establish long-term external manufacturing and lifecycle management strategies supporting global commercialization.
- Provide technical and strategic oversight for drug substance and drug product process development (including cell line development, process development, formulation development, and manufacturing).
- Oversee development of robust analytical methods and product characterization, including product comparability assessments.
- Ensure successful scale-up, technology transfer, process validation, and commercial readiness.
- Build and manage a network of CDMOs and strategic manufacturing partners supporting biologics development and manufacturing.
- Lead governance structures and strategic partnerships with external manufacturers.
- Ensure reliable clinical and commercial supply through effective planning, risk mitigation, and partnership with Supply Chain.
- Provide leadership for CMC regulatory strategy supporting INDs, BLAs, and global regulatory filings.
- Partner with Quality and Regulatory Affairs to ensure global compliance with GMP and regulatory requirements.
- Support regulatory agency interactions, inspections, and CMC submission strategy.
- Build and lead a high-performing biologics technical development and operations organization; recruit, develop, and mentor senior leaders.
- Foster a culture of scientific excellence, operational discipline, and continuous improvement.
- Partner with R&D, Clinical Development, Regulatory Affairs, Quality, Supply Chain, and Commercial teams to ensure integrated development and launch readiness.
- Contribute to portfolio planning and corporate strategy discussions related to biologics development and manufacturing.
Qualifications / Required Skills
- MS or PhD in Biochemistry, Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline.
- 12+ years of progressive experience in biologics process development, product characterization, manufacturing, and technical operations within the biotechnology industry.
- Demonstrated leadership advancing biologic therapeutics from development through late-stage clinical trials and commercialization.
- Experience leading product comparability studies supporting BLA submissions and commercial launch preparation.
- Experience establishing and managing global biologics manufacturing networks.
- Experience with monoclonal antibodies, recombinant proteins, or other complex biologics modalities.
- Deep expertise in biologics CMC development, including cell culture and purification development, analytical development, formulation development, and manufacturing scale-up.
- Strong knowledge of GMP requirements and global regulatory expectations for biologics.
- Significant experience contributing to regulatory submissions (IND, BLA, or equivalent), including product comparability assessments.
- Proven ability to lead complex development programs and organizations in a fast-paced biotechnology environment.
- Strong strategic thinking, executive communication, and stakeholder management skills.
- Demonstrated ability to build high-performing teams and external partnerships.
Compensation / Benefits
- Targeted Base: $245,987 - $303,866.
- Regular employees may be eligible for a corporate bonus program or incentive compensation program (if applicable), as well as equity.
- Additional benefits include health care, vision, dental, retirement, PTO, etc.