Process Development Engineer

Process Development Engineer, Technical Operations

Lyndra Therapeutics is seeking an talented Process Development Engineer to join the Technical Operations group. This is an exciting role which will support the scale up of manufacturing processes through commercial scale for Lyndra's products with a focus on advanced technologies including state-of-the-art polymer laser welding. The person in this position will be responsible for end-to-end process development activities, subject matter expert contributions to applicable filings, and cross-functional collaboration with stakeholders across the organization. The successful candidate will be a strong communicator, a detail oriented experimentalist who is prepared to work hands-on, and a mission-driven team player.

Lyndra's LYNX long-acting oral drug delivery platform is paving the way for a step change in the way patients take oral medication. Our groundbreaking platform will enable today's daily oral medications to be delivered on a weekly basis or even longer.

Primary Responsibilities

• Lead the design, execution, and analysis of process development experiments aimed at improving process yield and realizing new product developments at scale

• Develop manufacturing control strategies for batch and quasi-continuous processes

• Drive tech transfer activities from clinical to commercial scale manufacturing facilities

• 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

• Present findings to a variety of stakeholders including technical and CMC leadership groups

• Generate detailed documentation of work including reports, SOPs, investigations, laboratory notebooks according to Good Documentation Practices (GDPs)

• 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

Required Qualifications

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

• Strong knowledge of process development best practices including statistical analysis, design of experiments methodology (DoE), and root cause analysis techniques

• Experience working within cGMP guidelines for pharmaceutical manufacturing

• Experience working hands-on in a laboratory or manufacturing setting

• Self-motivated and skilled at establishing development plans requiring cross-functional collaboration and driving the plans through successful execution

• Energized by working collaboratively as part of team

• Strong, detail-oriented communication and documentation skills

Additional Desired Skills

• Knowledge of CMC regulations and experience contributing to pharmaceutical regulatory filings

• Experience with tech transfer, including to external partners

• Experience generating user requirements specifications (URS) and delivering on custom manufacturing equipment

• Familiar with IQ, OQ, and PQ processes

• Familiar with JMP statistical software

• Proficient with scripting programming language(s)