Job Overview As the GET PE – Synthetics Drug Product Manufacturing Senior Principal Engineer, you will lead early design inputs and technical strategy for synthetic drug product manufacturing processes, including controlled bioburden and drug product manufacturing across strategic capital projects, network studies, and technology platforms within IMSC. The role involves expertise in oral solid dose (OSD) products, bioavailability‑enhanced technologies, and innovative drug product forms, supporting optimization activities across internal and external manufacturing sites.
Responsibilities Lead the intake, scoping, prioritization, and resolution of synthetics controlled bioburden‑drug product manufacturing related technical requests across global sites.
Lead and influence early‑phase process design and domain expertise for oral solid dose (OSD) products, covering both batch and continuous manufacturing platforms and new innovative drug product forms.
Lead and influence early‑phase process design for bioavailability‑enhanced technologies, including amorphous solid dispersions (ASD) with a strong emphasis on spray drying, and other technologies such as Self‑Emulsifying Drug Delivery Systems (SEDDS) and related innovative intermediate formulation approaches.
Ensure robust, fit‑for‑purpose process design while promoting standardization and platform approaches where valuable.
Provide expert input and alignment on key process, equipment, and technology selection decisions for drug product manufacturing.
Actively collaborate with functions such as R&D, MSAT, Quality, EHS, and Operations across synthetic drug product sites.
Find opportunities for harmonization, shared solutions, and best‑practice exchange across the network.
Foster a culture of collaboration to reduce duplication, accelerate implementation, and improve speed‑to‑market.
Maintain strong connections with industry experts and external networks (e.g., ISPE) to bring innovative drug product manufacturing solutions into the organization.
Ensure alignment with enterprise strategies, GMP requirements, and technology roadmaps.
Collaborate with External Manufacturing teams to prioritize support and resolve issues for high‑impact programs and partners.
Qualifications Education: Minimum of a Master’s degree or equivalent experience in Engineering, Pharmaceutical Sciences, or a related technical field.
Experience and Skills: Minimum 10 years of relevant experience in synthetics controlled bioburden drug product manufacturing, with a strong focus on OSD processes and innovative technologies (e.g., semi‑solid).
Demonstrated expertise in bioavailability‑enhanced technologies, including ASD (amorphous solid dispersions) – deep knowledge of spray drying – and SEDDS or similar innovative formulation approaches.
Proven track record of leading multi‑functional teams and influencing technical decisions in complex, global organizations.
Experience with OSD controlled bioburden manufacturing, including batch and continuous processes and associated equipment.
Strong understanding of cGMP environments and regulatory expectations for controlled bioburden‑drug product manufacturing; aseptic capability is a plus.
Experience in supporting early‑phase design, detail design, start‑up processes, and commissioning & qualification (C&Q) of controlled bioburden (and aseptic) equipment.
Knowledge of inherently safe containment design for components with low exposure level.
Drive the adoption of digital and data‑enabled solutions for DP manufacturing, including real‑time monitoring, advanced process control, advanced analytics, modeling, simulation, and smart manufacturing use cases.
Strong customer management and communication skills, with the ability to influence across sites, functions, and external partners.
Strategic attitude combined with hands‑on technical capability.
Intellectual curiosity to challenge the status quo, influence without authority, and cultivate an inclusive collaborative culture.
Proficiency in written and spoken English.
Willingness to travel up to 25% domestically and internationally.
Preferred: Strategic attitude combined with hands‑on technical capability.
Intellectual curiosity to challenge the status quo, influence without authority, and cultivate an inclusive collaborative culture.
Additional languages (Dutch, Spanish, Italian) are an advantage.
Preferred skills: Agile Decision Making, Coaching, Consulting, Corrective and Preventive Action (CAPA), Crisis Management, Cross‑Functional Collaboration, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, STEM application, Tactical Planning, Technical Credibility, Technical Research.
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