Director, Analytical Development and Quality Control (Biologics)

zenasbio; Waltham (MA); Hybrid; USD 177,000 - 221,000; Full time

Benefits offered by this job

LI-Hybrid

Job summary

Zenas is seeking a Director of Analytical Development and Quality Control to lead strategy, development, and execution of analytical methods supporting biologics from early research through commercialization. As a key member of Technical Operations, the candidate will bring deep expertise in cell-based assays, leadership, and cross-functional collaboration in a fast-paced biotech environment.

You will partner with Process Development, Quality, Regulatory, and Manufacturing to ensure readiness

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Analytical Sciences, or a related field required; advanced degree preferred.
• 10+ years of relevant experience in analytical development within the biopharmaceutical or biotechnology industry.
• Strong background in biological cell-based assay method development.
• Experience in small-molecule analytical is a plus.
• Proven experience with method development, validation, and regulatory submissions.
• Deep understanding of ICH, FDA, and EMA regulatory requirements.
• Excellent communication, leadership, and organizational skills.
• Ability to manage multiple programs and priorities in a dynamic environment.

Responsibilities

• Develop and execute the analytical development strategy to support biologics product development across all stages (preclinical to commercial).
• Partner with Process Development, Quality, Regulatory, and Manufacturing to ensure analytical readiness and compliance.
• Serve as a subject matter expert on key technical aspects of cell-based assay development, including protein conjugation, antibody screening, assay diluent formulation, preanalytical sample processing, scale-up, assay optimization, troubleshooting, data analysis, and analytical method validation.
• Oversee development, qualification validation and transfer of analytical methods for characterization, release, and stability testing.
• Guide analytical comparability studies and support tech transfer to internal and external manufacturing and QC labs.
• Provide oversight of deviations, OOS/OOT investigations, and root cause identification, ensuring timely resolution.
• Author and review analytical sections of regulatory filings (IND, IMPD, BLA, MAA).
• Ensure analytical methods and data meet regulatory expectations and ICH guidelines.
• Support CMC strategy, inspections, and audits.
• Serve as analytical development representative on project teams.
• Collaborate closely with discovery, process development, formulation, and quality teams to ensure robust product understanding.
• Evaluate and implement new technologies and analytical platforms to advance product characterization and process understanding.

Skills

Leadership

Analytical method development

Cell-based assay development

Regulatory submissions

ICH/FDA/EMA knowledge

Regulatory readiness

Cross-functional collaboration

Education

Bachelor's degree in Chemistry/Biochemistry/Analytical Sciences

Advanced degree preferred

Job description

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas' lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab's unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton's Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas' earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcγRIIb monoclonal antibody.

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation - TRUE Innovation !

Position Summary:

The Director of Analytical Development and Quality Control will lead the strategy, development, and execution of analytical methodologies to support biologics product development from early research through commercialization. As a key member of the Technical Operations team, the ideal candidate will have deep scientific expertise in cell-based assays, leadership experience, and a proven ability to work cross-functionally in a fast-paced biotech environment.

Key Responsibilities:

• Develop and execute the analytical development strategy to support biologics product development across all stages (preclinical to commercial).
• Partner with Process Development, Quality, Regulatory, and Manufacturing to ensure analytical readiness and compliance.
• Serve as a subject matter expert on key technical aspects of cell-based assay development, including protein conjugation, antibody screening, assay diluent formulation, preanalytical sample processing, scale-up, assay optimization, troubleshooting, data analysis, and analytical method validation.
• Oversee development, qualification validation and transfer of analytical methods for characterization, release, and stability testing.
• Guide analytical comparability studies and support tech transfer to internal and external manufacturing and QC labs.
• Provide oversight of deviations, OOS/OOT investigations, and root cause identification, ensuring timely resolution.
• Author and review analytical sections of regulatory filings (IND, IMPD, BLA, MAA).
• Ensure analytical methods and data meet regulatory expectations and ICH guidelines.
• Support CMC strategy, inspections, and audits.
• Serve as analytical development representative on project teams.
• Collaborate closely with discovery, process development, formulation, and quality teams to ensure robust product understanding.
• Evaluate and implement new technologies and analytical platforms to advance product characterization and process understanding.

Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Analytical Sciences, or a related field required; advanced degree preferred.
• 10+ years of relevant experience in analytical development within the biopharmaceutical or biotechnology industry.
• Strong background in biological cell-based assay method development.
• Experience in small-molecule analytical is a plus.
• Proven experience with method development, validation, and regulatory submissions.
• Deep understanding of ICH, FDA, and EMA regulatory requirements.
• Excellent communication, leadership, and organizational skills.
• Ability to manage multiple programs and priorities in a dynamic environment.

#LI-Hybrid

The position is eligible for a competitive compensation and benefits package.

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $176,900 to $221,219 . Actual co