The Director Analytical Development, ADQC is a leadership position within Analytical Development and Quality Control (ADQC) department, responsible for providing strategic and technical leadership for analytical development activities supporting biologics programs from early phase to pivotal phase, BLA/MAA submission, and commercialization. This role will lead phase appropriate analytical control strategy, method development, qualification/validation, method transfer to internal and external laboratories, method lifecycle management, and ensure analytical readiness to support CMC milestones and regulatory submissions.
The incumbent will work closely with Quality Control, Quality Assurance, Process Development, Manufacturing, Regulatory Affairs, and external partners to establish robust scientifically sound, phase -appropriate analytical strategies.
This is a highly visible leadership role requiring strong scientific judgement, hands-on laboratory expertise, and the ability to effectively develop junior staff and manage external partners in a highly regulated, fast-paced environment.
Duties and Responsibilities (Responsibilities include but are not limited to):- Provide strategic and technical leadership for analytical development activities for biologics, including phase appropriate analytical control strategies, late stage/commercial assay reduction strategy, method development, validation, transfer to internal and external QC labs, and lifecycle management.
- Ensure analytical readiness for late‑stage development, PPQ, and commercial launch of SAB-142 polyclonal antibody program.
- Oversee and perform hands-on analytical work at SAB’s development and GMP labs.
- Provide hands-on and supervisory support to method troubleshooting, method optimization, method bridging, method performance monitoring, investigations (deviations, system suitability failure, OOT, OOS), CAPA, change control, and continuous method improvement initiatives.
- Lead and manage reference standard program, critical reagent program, extended characterization strategies and testing, forced degradation/stress sample study, comparability, and specification setting.
- 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.
- Authoring and ownership of regulatory CMC analytical sections, as well as the ability to provide technical input across all CMC-related sections.
- Scale analytical capabilities, oversee equipment qualification and maintenance, implement workflows and LIMS, and design/establish non-GMP development lab area.
- Signature authority for all analytical documents and data.
- 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 has supervisory responsibilities.
Education/Experience/Skills:- Advanced degree (PhD preferred) in Biochemistry, Biophysics or a related discipline, with 8+ years of biopharma industry experience, of which at-least 4 years in management role, in analytical development for biologics.
- Deep hands-on expertise in A280, HPLC, CE, LC-MS, ELISA, and cell-based potency methods for biologics. Experience in flow cytometry desired.
- Proficient in trend analysis and simple statistical analysis.
- Strong understanding of phase‑appropriate analytical control strategies, method validation, method transfer and applicable guidelines (ICHQ2R2, ICH Q14, FDA guidance documents, USP chapters etc.) with deep expertise in cGMP requirements.
- Experience in reference standard program, critical reagent program, and forced degradation study
- Demonstrated success supporting regulatory submissions (IND/IMPD, BLA/MAA).
- Proven experience managing external partners and driving outsourced analytical activities.
- Demonstrated ability to work effectively in a fast-paced, small biotech/pharma environment with experience in late-phase pre-commercial biotech/pharma particularly desirable.
- Strong written and verbal communication and technical writing skills and the ability to effectively present information in one-on-one, departmental, and 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.
This is a Remote role.
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