Analytical Development Supervisor

SAB; Sioux Falls, Northern (SD, KY); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

SAB BIO is seeking an Analytical Development Supervisor to lead hands-on analytics in the ADQC lab, from method development through transfer to internal and external labs. You will ensure cGMP compliance and drive data integrity for biologics programs. The role supports regulatory submissions and lifecycle management of analytical methods.

Relocation assistance is available. The position requires strong technical writing, data analysis, and collaboration with QA/QC teams to ensure inspection

Qualifications

• Bachelor's degree with 7+ years of relevant experience in biotech/pharma.
• Experience with bioanalytical methods and regulatory guidelines (ICH, FDA).
• Experience with reference standard programs and forced degradation studies.
• Experience presenting technical data in group settings.

Responsibilities

• Lead hands-on analytical work including method development, qualification, validation, transfer, and documentation.
• Ensure readiness for late-stage development, PPQ, and commercial launch related to SAB-142 program.
• Lead troubleshooting, method improvement, investigations, CAPA, and change control activities.
• Participate in qualification and stability monitoring of references standards and critical reagents.
• Ensure analytical activities comply with cGMP, ICH, USP/EP, and global regulations.
• Support specification setting and regulatory submissions.
• Manage lab operations, equipment qualification, and use of LIMS.
• Collaborate with Quality Control/Assurance to maintain GMP compliance and inspection readiness.

Skills

Method development

Validation

Data analysis

Technical writing

Communication

Troubleshooting

Quality systems

LIMS workflows

Education

Bachelor's degree in life sciences

7+ years in biotech/pharma

Master’s degree desired

Tools

HPLC

A280

CE-SDS

cIEF

LC-MS

ELISA

Office software (Word/Excel/PowerPoint)

LIMS

Job description

The Analytical Development Supervisor within the ADQC department serves as an operational level member of management within the ADQC laboratory. This role focuses on driving day-to-day lab performance, ensuring consistent cGMP and regulatory compliance and data integrity standards. The role is responsible for executing analytical development activities supporting biologics programs from early phase to pivotal phase, regulatory submission, and commercialization. This role will lead method development, optimization, qualification, validation, method transfer to internal and external laboratories, method lifecycle management, and ensure analytical readiness to support CMC milestones and regulatory submissions.

Some relocation assistance is available for this role.

Duties and Responsibilities (Include but are not limited to):

• Lead and perform hands-on analytical work including method development, qualification, validation, transfer to internal and external QC labs, lifecycle management, and author associated documentation (method development reports, technical reports, qualification / validation reports, method SOP etc.)
• Ensure analytical readiness for late‑stage development, PPQ, and commercial launch of SAB-142 polyclonal antibody program.
• Lead and perform hands-on method troubleshooting, method optimization, method bridging, method performance monitoring, investigations (deviations, system suitability failure, OOT, OOS), CAPA, change control, continuous method improvement initiatives, and author associated documentation.
• Contribute to qualification and stability monitoring of reference standard, assay control, and critical reagents, qualification and testing of extended characterization assays, and forced degradation/stress sample study.
• Ensure analytical activities performed internally and at external partners are scientifically rigorous, comply with cGMP, ICH, USP, global regulations, and QbD principles, and align with industry’s best practices and company quality standards.
• Contribute to specification setting, and regulatory submissions.
• Manage general laboratory operations, equipment qualification & maintenance, support the scaling of analytical capabilities, establishment of analytical non-GMP development area, and implementing workflows and LIMS.
• Partner closely with Quality Control and Quality Assurance to establish, maintain, and oversee analytical quality, GMP compliance infrastructure, and inspection readiness for internal and external analytical documents and data.
• Other duties/responsibilities as assigned.

Supervisory Responsibilities:

This position does not supervise employees at the start. May supervise junior staff as the group expands.

Will have indirect supervisory level responsibilities with external partner/CDMO partnerships, and relationships.

Education/Experience/Skills:

• Bachelor's degree with 7+ years of progressively responsible and relevant experience in life sciences, Biophysics, Biochemistry or a related discipline in a biotech/pharma environment.. Master’s degree highly desirable.
• Deep hands-on expertise in A280, HPLC, CE-SDS, cIEF, and LC-MS for biologics. Experience in ELISA, and cell-based potency methods is a plus.
• Strong understanding of method validation, method transfer, and applicable guidelines (ICH, FDA guidance documents, USP/EP chapters etc.) with deep expertise in cGMP requirements.
• Experience in reference standard program, critical reagent program, and forced degradation study
• Utilizes established mathematical and scientific techniques including simple statistical analysis to compile and analyze data. Trend analysis /control charting is a plus.
• Strong written and verbal communication and technical writing skills and the ability to effectively present information in one-on-one, small groups, and departmental/cross functional meetings.
• Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint and Outlook).

Working Environment and Travel:

Duties will be performed in normal office, laboratory and BSL2 laboratory environments.

Travel is not typical for this position.

Physical Requirements:

Ability to regularly move up to 10 pounds. Specific vision abilities required by this individual include close vision, peripheral vision, and the ability to adjust focus. The employee will view a computer monitor for long periods of time.

ADA:

The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

This job description will be reviewed periodically as duties and responsibilities change with business necessity. Primary and additional duties and responsibilities are subject to modification.

SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.EOE/AA/Vets