Associate Director, External Manufacturing

Scorpion Therapeutics; Madison (WI); On-site; USD 180,000 - 260,000; Full time

Job summary

Scorpion Therapeutics seeks an experienced CDMO program lead to manage external manufacturing partnerships for drug substance, conjugation, and drug product operations. You will serve as the primary technical and business interface, directing transfers, governance, and performance reviews with 1–3 strategic CDMOs.

You will drive on-time, in-full delivery, monitor KPIs, review batch records, CAPAs, and change controls.

Qualifications

• PhD, MS, or BS in Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related field.
• 8+ years (or less with PhD) in biopharmaceutical technical operations/external manufacturing/CMC with progressive responsibility.
• Proven experience managing CDMO relationships as primary technical/business owner (technology transfer, GMP oversight, performance management).
• Required: synthetic oligonucleotide manufacturing experience; strong preference for GalNAc conjugates/targeted RNA delivery technologies.
• Ability to lead/influence in a cross-functional, matrixed environment (PD, AD, Quality, Regulatory, Supply Chain).
• Experience supporting late-stage clinical programs/commercial launches (PPQ; BLA/NDA-supporting activities).
• Strong working knowledge of FDA/EMA/ICH GMP and supporting regulatory inspections at CDMOs.
• Excellent written/verbal communication; translate technical detail into executive recommendations.

Responsibilities

• Serve as single point of accountability and primary technical/business interface for CDMOs supporting drug substance, conjugation, and/or drug product manufacturing.
• Lead day-to-day CDMO operations: governance meetings, escalation pathways, and performance reviews; build trust with CDMO leadership.
• Drive on-time, in-full, in-specification delivery of clinical and commercial supply; monitor KPIs (yield, cycle time, right-first-time).
• Lead and approve technology transfers from internal Process Development into CDMOs.
• Review/approve batch records, deviations, CAPAs, change controls, investigations, risk assessments, and validation documents from CDMOs.
• Develop/execute risk mitigation for critical raw materials, secondary sourcing, and capacity contingency.
• Partner with Procurement and Legal on commercial terms, statements of work, quality agreements, and capacity reservations.
• Cross-functional leadership across PD, Analytical Development, Quality, Regulatory, Supply Chain, Program Management, and Clinical Supply.
• Provide technical oversight of solid-phase oligonucleotide synthesis, purification (HPLC, TFF/UF-DF), lyophilization, ligand conjugation (e.g., GalNAc).
• Support drug product formulation, sterile filtration, fill-finish, and stability.
• Lead PPQ, validation, and commercial supply readiness; support comparability assessments; drive COOG optimization.
• Contribute CMC sections (IND/CTA/BLA/NDA) and support regulatory interactions, pre-approval inspections, and QA audits.

Skills

CDMO management

External manufacturing oversight

Cross-functional leadership

Executive communication

Education

PhD, MS, or BS in Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related field

Tools

HPLC

TFF/UF-DF

Lyophilization

Job description

Responsibilities:

• Serve as single point of accountability and primary technical/business interface for 1–3 strategic CDMOs supporting drug substance, conjugation, and/or drug product manufacturing.
• Lead day-to-day CDMO operations: joint operating cadences, governance meetings, escalation pathways, and performance reviews; build trust with CDMO leadership/technical teams.
• Drive on-time, in-full, in-specification delivery of clinical and commercial supply; monitor KPIs (yield, cycle time, right-first-time, deviation rate, on-time release).
• Lead and approve technology transfers from internal Process Development into assigned CDMOs.
• Review/approve batch records, deviations, CAPAs, change controls, investigations, risk assessments, and validation documentation from CDMOs.
• Develop/execute risk mitigation for critical raw materials, secondary sourcing, and capacity contingency.
• Partner with Procurement and Legal on commercial terms, statements of work, quality agreements, and capacity reservations.
• Cross-functional leadership across PD, Analytical Development, Quality, Regulatory, Supply Chain, Program Management, and Clinical Supply; translate program priorities into CDMO deliverables and resolve issues in a matrixed environment.
• Provide technical oversight of solid-phase oligonucleotide synthesis, purification (HPLC, TFF/UF-DF), lyophilization, ligand conjugation (e.g., GalNAc), and related unit operations.
• Support drug product formulation, sterile filtration, fill‑finish, and stability.
• Lead PPQ, validation, and commercial supply readiness; support comparability assessments; partner on demand planning/capacity modeling/S&OP; drive cost‑of‑goods optimization.
• Contribute CMC sections (IND/CTA/BLA/NDA) and support regulatory interactions, pre‑approval inspections, and inspection readiness; partner with QA on quality agreements/audits.

Requirements:

• PhD, MS, or BS in Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related field.
• 8+ years (or less with PhD) in biopharmaceutical technical operations/external manufacturing/CMC with progressive responsibility.
• Proven experience managing CDMO relationships as primary technical/business owner (technology transfer, GMP oversight, performance management).
• Required: synthetic oligonucleotide (siRNA or ASO) manufacturing experience; strong preference for GalNAc conjugates/targeted RNA delivery technologies.
• Ability to lead/influence in a cross‑functional, matrixed environment (PD, AD, Quality, Regulatory, Supply Chain).
• Experience supporting late‑stage clinical programs/commercial launches (PPQ; BLA/NDA‑supporting activities).
• Strong working knowledge of FDA/EMA/ICH GMP and supporting regulatory inspections at CDMOs.
• Excellent written/verbal communication; translate technical detail into executive recommendations.

Preferred:

• Lead complex strategy projects with minimal direction.
• Experience developing operations network strategies for a growing global market.

Onsite:

Based onsite; expected in office five days a week.