Sr Principal Eng - Process Engineering

Experteer Overview

Lead and shape early design and technical strategy for synthetic drug product manufacturing, focusing on controlled bioburden and innovative formulations. Collaborate across R&D, MSAT, Quality, EHS, and Operations to standardize platforms and accelerate speed-to-market. Influence equipment and process choices for OSD and new drug product forms, across global sites with a strong emphasis on bioavailability technologies. Join a global engineering team driving technology direction and network-wide harmonization.Retribuzione / Benefits

• Lead intake, scoping, prioritization, and resolution of synthetics bioburden—drug product manufacturing technical requests across global sites
• Lead early-phase process design for oral solid dose (OSD) products, including batch and continuous manufacturing
• Lead early-phase design for bioavailability enhanced technologies (ASD, spray drying; SEDDS) and related formulations
• Ensure robust, standardised process designs and promote platform approaches
• Provide expert input on process, equipment, and technology selection decisions for drug product manufacturing
• Collaborate with R&D, MSAT, Quality, EHS, and Operations across sites
• Identify opportunities for harmonization and best-practice sharing across the network
• Foster cross-site collaboration to reduce duplication and accelerate implementation
• Maintain connections with industry experts and external networks (e.g., ISPE) to bring innovative solutions
• Ensure alignment with GMP requirements and enterprise technology roadmaps
• Collaborate with External Manufacturing teams to priority support high-impact programs

Responsabilità

• Minimum 10 years of relevant experience in synthetics controlled bioburden drug product manufacturing
• Strong focus on OSD processes and innovative technologies (e.g., semi-solid) in drug product manufacturing environments
• Proven expertise in bioavailability enhanced technologies, including ASD and spray drying, plus SEDDS
• Experience with OSD controlled bioburden manufacturing, both batch and continuous processes
• Solid understanding of cGMP and regulatory expectations; aseptic capability is a plus
• Proven leadership of multi-functional teams and influencing decisions in large organizations
• Ability to support early-design, Start-up, and C&Q of controlled bioburden equipment
• Willingness to travel up to 25% domestically and internationally
• Strong English communication skills
• Strategic mindset with hands‑on technical capability

Requisiti fondamentali

• annual bonus
• vacation days
• parential leave (min 12 weeks)
• bereavement leave
• well‑being reimbursement
• insurance plans

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