Remote Director, Biologics Analytical Development & Strategy

SAB; Sioux Falls (SD); Remote; USD 180,000 - 280,000; Full time

Job summary

SAB BIO seeks a Director of Analytical Development, ADQC to lead analytical development activities for biologics from early phase to commercialization. Role involves strategy, method development, validation, transfer, and lifecycle management across internal and external labs.

The incumbent will drive cGMP compliance, support regulatory submissions, and manage external partners in a fast-paced biotech environment. Remote work option available.

Qualifications

• Advanced degree (PhD preferred) in Biochemistry, Biophysics or related discipline with 8+ years in biopharma, including at least 4 years in a management role in analytical development.
• Hands-on expertise in A280, HPLC, CE, LC-MS, ELISA; experience in flow cytometry is desired.
• Strong understanding of phase-appropriate analytical control strategies, method validation/transfer and cGMP requirements; track record in regulatory submissions.

Responsibilities

• Provide strategic and technical leadership for analytical development activities for biologics across development stages and lifecycle.
• Ensure analytical readiness for late-stage development, PPQ, and commercial launch of programs.
• Oversee hands-on analytical work in SAB's development and GMP labs and supervise method troubleshooting and optimization.
• Lead reference standard, critical reagent programs, forced degradation studies, and investigations with CAPA and change control.
• Author and input regulatory CMC analytical sections and ensure compliance with ICH, USP, and global guidelines, including QbD principles.

Skills

HPLC

CE

LC-MS

ELISA

Flow cytometry

Analytical control strategies

cGMP

Regulatory submissions

Education

PhD in Biochemistry/Biophysics

Tools

LIMS

Microsoft Office

Job description

SAB BIO seeks a Director of Analytical Development, ADQC to lead analytical development activities for biologics from early phase to commercialization. Role involves strategy, method development, validation, transfer, and lifecycle management across internal and external labs.

The incumbent will drive cGMP compliance, support regulatory submissions, and manage external partners in a fast-paced biotech environment. Remote work option available.