Director, CMC (Biologics Fill-Finish and Drug-Device Combination Products) in Birmingham

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 a Director‑level technical leader with deep expertise in biologics fill‑finish and drug–device combination products, including pre‑filled syringes (PFS) and autoinjectors. This role will provide hands‑on leadership across drug product development, aseptic manufacturing, and device integration from late development through commercialization. The Director will serve as a key technical partner across CMC, device engineering, regulatory affairs, quality, supply chain, and external partners, ensuring robust, compliant, and scalable delivery systems for injectable biologics. The role requires strong knowledge of EU MDR requirements, including direct contribution to Notified Body and Article 117 submissions.

Responsibilities:

• Provide technical leadership for aseptic fill‑finish of biologics, including formulation delivery, process design, scale‑up, tech transfer, PPQ, and commercial manufacturing support.
• Lead technical decision‑making related to container closure systems including vials, and pre‑filled syringes.
• Assess and mitigate risks related to particulates, container closure integrity (CCI), extractables and leachables (E&L), protein stability, adsorption, and subvisible particles.
• Support selection, qualification, and ongoing oversight of fill‑finish CMOs, including tech transfer execution, deviation management, and continuous improvement.
• Act as the technical lead for drug–device combination products, including pre‑filled syringes and auto injectors.
• Lead drug–device integration activities, including syringe geometry, stopper and plunger interactions, siliconization strategy, break‑loose and glide force performance, dose delivery accuracy, and container–device compatibility.
• Provide hands‑on technical leadership in autoinjector platform assessment, selection, and customization, working closely with external suppliers.
• Drive combination product risk management, including design controls, FMEA, usability and human factors inputs, transport qualification, shelf‑life strategy, and change impact assessments.
• Lead or significantly contribute to EU MDR Notified Body submissions, including preparation, coordination, and review of device technical documentation (device description, GSPR compliance, risk management files, usability and performance evidence).
• Technical support for Article 117 submissions, including definition and justification of the drug–device interface.
• Direct interaction with Notified Bodies to address technical questions, deficiency letters, and corrective actions.
• Partner closely with Regulatory Affairs and Quality to ensure alignment across EU, US, and global combination product requirements.
• Provide technical input to CMC regulatory strategies and submissions (IND, CTA, BLA, MAA) related to drug product, fill‑finish, and device components.
• Author, review, or approve Module 3 sections, technical reports, comparability assessments, and regulatory responses.
• Support global health authority inspections and audits, acting as a technical subject matter expert for fill‑finish and combination products.
• Ensure activities are compliant with GMP, EU MDR, FDA combination product regulations, ISO 13485, and relevant pharmacopeial standards.
• Serve as the day‑to‑day technical owner for assigned programs, escalating risks and decisions as appropriate.
• Collaborate effectively with process development, QA, regulatory, Clinical Trials Supply, and external CDMO stakeholders.
• Contribute to continuous improvement initiatives and adoption of new fill‑finish and device technologies.

Required Qualifications:

• 10+ years of experience in biologics drug product development, fill‑finish, or manufacturing.
• Demonstrated hands‑on expertise in aseptic fill‑finish operations.
• Significant experience with pre‑filled syringes and autoinjectors, preferably across multiple development stages.
• Direct experience supporting EU MDR Notified Body interactions and/or Article 117 submissions.
• Experience supporting regulatory filings and health authority interactions.
• Proven ability to work effectively with external CMOs and device suppliers.

Preferred Qualifications:

• Experience working in a matrixed, cross‑functional environment.
• Familiarity with on‑body delivery systems or advanced injector platforms.

Education: PhD, MS, or BS in Chemical Engineering, Pharmaceutical Sciences, Biomedical Engineering, or related discipline.