Solid Dose Process Engineering Director at Puretek Corporation – Los Angeles, California

Position summary

The Director Solid Oral Dose Process Engineering is responsible for leading the design, development, scale‑up, and commercialization of oral solid dosage (OSD) drug products (e.g., tablets, capsules, granules) from lab and pilot scale through validated commercial manufacturing. This role provides cross‑functional technical leadership across formulation, process development, tech transfer, and commercial process optimization, ensuring robust, compliant, and cost‑effective processes that meet quality, regulatory, and business objectives in a US FDA‑regulated environment. The position partners closely with R&D, Operations, Quality, Regulatory, and external CDMOs to drive pipeline advancement, launch readiness, and lifecycle changes for solid-dose products.

Key responsibilities

• Lead the end‑to‑end development of solid oral dosage processes, including pre‑formulation, formulation, and process design for unit operations such as blending, granulation (wet/dry), drying, milling, compression, encapsulation, and coating.
• Own process scale‑up and tech transfer from R&D to pilot and commercial sites, including definition of scale‑up strategies, critical process parameters (CPPs), and control strategies using QbD and DOE tools.
• Provide technical leadership for process performance qualification (PPQ), validation, and commercial process monitoring for solid-dose products, ensuring US FDA expectations are met for new products and post‑approval changes.
• Direct and mentor a team of process, formulation, and manufacturing engineers/scientists supporting solid-dose R&D and commercialization activities across internal plants and/or CDMOs.
• Collaborate with Analytical Development, Quality, and Regulatory to define product specifications, author and review CMC sections, and support responses to FDA questions related to process and control strategy.
• Drive implementation of advanced processing technologies (e.g., continuous manufacturing, PAT, high‑shear or fluid‑bed granulation, advanced coating) to improve robustness, yield, and cost for solid-dose manufacturing.
• Lead or support complex process investigations, root‑cause analysis, and CAPA for manufacturing deviations, OOS/OOT events, and yield or quality issues on commercial solid-dose products.
• Develop and maintain technical standards, SOPs, development reports, and tech transfer documentation to ensure knowledge capture and reproducible commercial performance.
• Partner with Supply Chain and Operations to evaluate and qualify new sites, equipment, and technologies for solid-dose manufacturing, including URS definition and participation in FAT/SAT and qualification.
• Provide strategic input to portfolio and pipeline decisions by assessing manufacturability, scale‑up risk, and life‑cycle opportunities for solid-dose candidates.

Qualifications

• Advanced degree (MS or PhD) in Chemical Engineering, Pharmaceutical Sciences, Process Engineering, or related field strongly preferred; BS with extensive relevant experience may be considered.
• Approximately 10+ years of experience in pharmaceutical oral solid dosage R&D, process development, and commercialization, including direct leadership of scale‑up and tech transfer to commercial manufacturing.
• Deep technical expertise in solid-dose formulation and unit operations (granulation, drying, milling, tableting, encapsulation, coating) and familiarity with QbD, DOE, PAT, and process validation principles.
• Proven track record of successful US product launches (e.g., NDA/ANDA) and demonstrated experience authoring or contributing to CMC regulatory filings for solid-dose products.
• Strong leadership experience managing technical teams and influencing cross‑functional stakeholders in R&D, Operations, Quality, and Regulatory.
• Thorough understanding of US cGMP, ICH guidelines, and FDA expectations for solid-dose development, validation, and commercial manufacturing, including lifecycle‑based process validation.