Associate Director/Director, Biologics Combination Product Dev & Manufacturing

Position Summary:

The Associate Director / Director, Biologics Combination Product Development and Manufacturing reporting to the Sr. Director, Biologics Combination Product Development and Manufacturing, will provide subject matter expertise for biologics combination product specifically Prefilled Syringe (PFS) based needle safety device and single use disposable autoinjectors development and manufacturing. This position will play a key role in needle safety device and autoinjector assembly, packaging, and/or inspection, and will be part of a team responsible for industrialization, process optimization, and validation of combination product across worldwide based external manufacturing sites. She/He will work with both internal and external project teams to develop robust combination product manufacturing processes and support a comprehensive and successful technology transfer to our CDMO’s.  She/He will contribute to building/maintaining excellent working relationships with device vendors and CDMOs. Working within a cross-functional team, she/he will support combination product life cycle management and strategic goals.

Key Responsibilities:

• Collaborates with internal CMC, Clinical, Commercial, Quality, and Regulatory departments and with external vendors and CDMOs to deliver combination product specifically PFS based needle safety device and autoinjectors project goals related to manufacturing according to project timelines.
• Provide engineering expertise to support cross-functional teams to collaboratively define and execute combination product specifically needle safety device and autoinjectors process development, manufacturing and technology transfer activities.
• Participate in the authoring of Design History Files, Risk Analysis, FMEA’s, Device Master Records, Combination product specifications, on all biologic based Zenas combination products.
• Support feasibility assessments, including prototyping, analysis and lab testing. Perform first principle analysis and modeling of key performance attributes of devices.
• Support the strategy for human factors/ usability engineering activities from initial formative studies to final human factors summative validation studies for combination products. Also support the subsequent design validation activities including summative human factors study from protocol development, study execution, and reporting.
• Perform technical risk management activities such as hazard analysis, and use-related risks analysis.
• Lead investigations and manage change control initiatives for new or improved designs for components, sub-assemblies and final combination product assemblies.
• Support product life-cycle initiatives with a focus on process optimization and reduction of COGS.
• Establishes and maintains an understanding of current trends and emerging technologies in the area of combination products development and manufacturing, specifically PFS based needle safety device and autoinjectors. 

Qualifications:

• BS/MS/Ph.D. in engineering or relevant technical discipline including biomedical engineering, mechanical engineering, chemical/biochemical engineering is required.
• A minimum of 8-15 years of hands-on experience in biologics combination product development and manufacturing in biotech or biopharma industry is required.
• Direct experience in development and commercialization of combination products utilizing commercial device platforms is required.
• Hands-on working experience in PFS based needle safety device and autoinjector assembly, packaging, and/or inspection.
• Experience in authoring protocols and technical reports summarizing key findings and results. Apply statistical analysis where appropriate.
• Knowledge of human factor/usability engineering, safety, performance and regulatory compliance requirements of medical device and combination products.
• Relevant combination product validation experience utilizing global quality and regulatory standards such as 21 CFR 820, ISO 9000,13485 and 14971. Strong knowledge of prefilled syringe, needle safety device and autoinjector technical standards (e.g., ISO 11040, ISO 11608, ISO 23908) is required.
• Demonstrated regulatory experience with combination product market applications (BLA, MAA etc.) is preferred.
• Experience with management and collaboration with CDMOs, design consultancy agencies, supply chain vendors, and outside testing laboratories.
• Be an effective and highly motivated self-starter and team player who can balance the needs of an entrepreneurial workplace culture within the requirements of a GMP environment.
• Ability to work non-traditional work hours when required, given international operations across time zones.
• Ability to do some international travel [up to 20%].

#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 $170,000 to $225,000.. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.