Strategic Process Engineer – API Scale-Up & Design

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics seeks a senior Process Engineer to guide scale-up of drug substance API manufacturing from lab to pilot plant in the Indianapolis area. You will translate development-scale chemistry into fit-for-purpose equipment specs, lead P&ID reviews, and ensure cGMP compliance across disciplines, vendors, and operations.

Responsibilities include modeling heat/mass transfer, reactor sizing, and process safety, with oversight of IND/CTX documentation and regulatory updates.

Qualifications

• PhD or equivalent with substantial process engineering experience in pharma/biotech/CMO.
• Experience translating development-scale chemistry to scalable API manufacturing equipment.
• Familiarity with cGMP, regulatory submissions, and pilot-scale operations.

Responsibilities

• Serve as technical authority for equipment design and scale-up calculations across the Foundry’s small molecule node.
• Lead detailed engineering calculations, heat/mass transfer modeling, and equipment sizing for production suites (small molecule, peptide, oligonucleotide).
• Direct rig-fit assessments for incoming processes using simulation tools to validate scale-up readiness.
• Provide guidance on reactor selection/design for batch/semi-batch, continuous flow, and synthesis platforms.
• Drive scale-up from lab/kilo lab to pilot plant with rigorous evaluation and documentation.
• Lead P&ID reviews and communicate design intent across disciplines, vendors, and partners.
• Develop and maintain drug substance API manufacturing processes and control strategies; translate development-scale chemistry into fit-for-purpose specs.
• Support IND/CTX sections and regulatory submissions/updates.

Skills

Process simulation

Unit operations

Cross-functional PM

Leadership & comms

DeltaV controls

Education

PhD in Chemical Engineering or related

BS/MS in Chemical Engineering or related with 10+ years

Tools

DynoChem

Aspen

DeltaV

Job description

Scorpion Therapeutics seeks a senior Process Engineer to guide scale-up of drug substance API manufacturing from lab to pilot plant in the Indianapolis area. You will translate development-scale chemistry into fit-for-purpose equipment specs, lead P&ID reviews, and ensure cGMP compliance across disciplines, vendors, and operations.

Responsibilities include modeling heat/mass transfer, reactor sizing, and process safety, with oversight of IND/CTX documentation and regulatory updates.