Who We Are:
Zura is a clinical‐stage biotechnology company advancing clinical development of novel therapeutic candidates for autoimmune and inflammatory diseases with significant unmet medical need. Our work is focused on understanding immune‐mediated disease and translating that science into carefully designed clinical programs, with patients and their challenges guiding our approach.
Zura is building and advancing a growing portfolio of clinical programs informed by strong scientific expertise and disciplined execution. Across the organization, teams work closely together to progress development thoughtfully, with a shared emphasis on data quality, rigor, and integrity.
At Zura, we operate as One Zura. This means collaborating across functions, valuing diverse perspectives, and taking shared ownership of our work—from problem‐solving to execution. Joining Zura means contributing to patient‐focused clinical development in a hands‐on environment where individual effort matters, collaboration is expected, and people are encouraged to grow while working toward a common goal.
What You'll Do:
We are seeking an experienced downstream biologics process development specialist to lead and support downstream process development, GMP manufacturing, process characterization and validation activities for biologic drug substances. The role requires strong technical expertise in downstream purification, coupled with experience authoring and reviewing regulatory CMC documentation to support clinical and commercial submissions in a fast paced, exciting virtual biotech environment. The successful candidate will work within the CMC team and cross functionally with the QA, and Regulatory teams to ensure robust, scalable, and compliant downstream processes across development and lifecycle stages.
Responsibilities:
* Lead and execute downstream process development for biologic drug substances, including: Protein A and non-ProteinA capture chromatography, intermediate and polishing chromatography (e.g. CEX, AEX, HIC), viral inactivation and viral filtration, ultrafiltration/diafiltration (UF/DF), final formulation, filtration, and bulk drug substance handling.
* Define robust process operating ranges and support scale up and technology transfer activities.
* Support development of control strategies using Quality by Design (QbD) principles, including identification of CQAs, CPPs, KPAs, and PARs.
* Liaise with CDMOs to plan and execute process characterization (PC) studies, including DoE based investigations and risk-based parameter selection.
* Partner with CDMOs to develop and qualify downstream scale down models to support viral clearance, comparability, and process validation activities.
* Contribute to or lead process validation (PPQ) strategies, including definition of validation approaches, acceptance criteria, and lifecycle validation plans.
* Interpret complex datasets and generate clear, defensible technical conclusions suitable for regulatory submission.
* Provide technical leadership and on site or remote support for GMP drug substance manufacturing campaigns at external manufacturing sites.
* Author, review, and approve GMP documentation, including: Manufacturing Batch Records (MBRs), Transfer Protocols (TTPs), Process Characterization and Validation Protocols and Reports, deviations, change controls, and CAPAs
* Partner closely with QA to ensure compliance with cGMP and data integrity requirements.
* Author, review, and contribute to regulatory CMC sections, including: IND / IMPD / CTA Module 3 sections, process descriptions, controls of critical steps, and validation summaries
* Ensure downstream process descriptions are scientifically sound, internally consistent, and aligned with regulatory expectations, similar to downstream manufacturing and control narratives found in Module 3 documentation.
* Support regulatory interactions by providing technical justifications and responses to agency questions related to downstream processing and validation.
* Act as a downstream subject matter expert within cross functional CMC teams.
* Collaborate with external CDMOs and technology partners to ensure aligned technical execution and documentation.
Required Qualifications:
* Significant industry experience in downstream biologics process development within a GMP environment.
* Demonstrated expertise in chromatography, viral clearance, and UF/DF operations for biologics.
* Direct experience with process characterization, scale down model qualification, and GMP clinical manufacturing.
* Experience working with external CDMOs for downstream development and GMP manufacture.
* Excellent scientific writing, data interpretation, and cross functional communication skills.
Preferred Qualifications:
* Experience supporting late stage or commercial biologics.
* Direct experience with process validation and PPQ execution.
* Proven experience authoring and reviewing regulatory CMC documentation (IND/IMPD/Briefing books etc.).
* Strong understanding of global regulatory expectations (FDA, EMA, ICH Q8/Q9/Q10).
* Prior interaction with health authorities or support of regulatory inspections.
* Familiarity with electronic document management systems and structured regulatory authoring practices.
Education:
* Bachelor's degree in Biochemical Engineering, Biotechnology, Chemistry, or a related discipline. Advanced degree is preferred.