Process Development Engineer (Assembly)

at  Lyndra Inc

COMPANY OVERVIEW

Lyndra Therapeutics is a clinical-stage biopharmaceutical company partnering to create and commercialize long-acting oral therapies. Our LYNX drug delivery platform transforms daily medicines into treatments that last a week or longer in a single oral dose. With the LYNX platform, we have the potential to fundamentally change how medicines are taken and delivered.

POSITION OVERVIEW

We are seeking a highly skilled and experienced Process Development Engineer with a strong background in assembly processes in the biotech or medical device industry to join Lyndra’s Technical Operations team. The ideal candidate will lead the design, development, and optimization of manufacturing processes to support onsite manufacturing campaigns and technical transfer to partners. This position involves collaboration with cross-functional teams to ensure robust, scalable, and compliant processes are developed that meet regulatory and quality standards. A hands-on approach to learning and problem-solving will be required to support development efforts and drive critical programs forward.

QUALIFICATIONS:

• B.S. or M.S. in Chemical/Mechanical/Biomedical Engineering or related field with 4-7 years of experience in pharmaceutical or medical device process development

SKILLS:

• Proficient in process validation and statistical analysis tools (e.g., JMP).
• Experience with scripting programming language(s)

• Lead the design, execution, and analysis of process development experiments aimed at improving quality, process yield and realizing new product developments at scale
• Identify new equipment and fixturing required to optimize manufacturing processes.
• Develop manufacturing control strategies for batch and quasi-continuous processes, including work instructions and assembly sequences.
• Drive tech transfer activities from clinical to commercial scale manufacturing
• Statistically analyze the performance of manufacturing processes to identify long term trends and opportunities for improvements to processes and equipment
• Contribute to New Drug Application (NDA) filing package, serving as a process expert in the authoring of key sections of the filing
• Generate detailed documentation of work including reports, SOPs, investigations, laboratory notebooks according to Good Documentation Practices (GDPs)
• Lead risk assessments as SME for manufacturing operations
• Collaborate with R&D, Analytical, Quality, Engineering, and Program Management functions to deliver on process development goals
• Provide hands-on support to clinical manufacturing operations, as needed