Associate Director Packaging Development

Scorpion Therapeutics; United States; On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Job summary

Scorpion Therapeutics seeks an Associate Director, Packaging Development to lead packaging strategy for combination products. You will govern packaging programs, influence across functions, and drive development, qualification, and commercialization efforts for biologics and related modalities.

Responsibilities include leading design controls, risk assessments, and regulatory submissions support, while mentoring engineers and improving processes within a matrixed organization.

Qualifications

• BS in packaging/engineering, plus 10+ years in the packaging field.
• Experience leading packaging development programs for combination products.
• cGMP experience with strong design controls and change control.
• Ability to influence in a matrixed organization.

Responsibilities

• Strategy & Governance: build packaging processes and governance across multiple teams.
• Technical Leadership: lead design reviews, risk assessments, and change control.
• Program Execution: drive packaging development, qualification, and commercialization.
• Cross-Functional Integration: collaborate with regulatory, device, QA, and others.
• Documentation & Continuous Improvement: author standards and regulatory submission sections.

Skills

Packaging engineering knowledge

Leadership in packaging development

cGMP experience

Design controls & change control

Regulatory submissions awareness

Education

BS in packaging/engineering

Job description

Job Description (Associate Director, Packaging Development)

• Provide technical leadership for packaging development, qualification, and commercialization activities for combination products.
• Serve as SME defining packaging strategies to support regulatory submissions and commercialization.
• Define combination product packaging processes; establish governance and operating framework for Packaging Engineering across the combination product ecosystem.
• Drive cross-functional alignment and resolution of complex technical/organizational issues.
• Independently lead packaging development programs across multiple product modalities; may be accountable for development, qualification, and commercialization supporting biologics and OSD based on priorities.

Key Responsibilities

• Strategy & Governance: build/integrate packaging development processes; establish governance/decision-making and interfaces across Packaging Eng., Device Eng., Device Quality, Regulatory Affairs, etc.; define/improve operating model/workflows/best practices.
• Technical Leadership: resolve complex issues; lead during design reviews, risk assessments, change management, governance forums; lead/support design control and hazard/risk assessments.
• Program Execution: lead packaging development/qualification/commercialization; assess manufacturing networks and capability gaps; evaluate/select materials/components/equipment/technologies; identify/evaluate/manage CMOs and external advisors.
• Cross-Functional Integration: collaborate with Human Factors/Human-Centered Design; interact with cross-functional teams; communicate goals/results.
• Documentation & Continuous Improvement: author technical documents/standards and regulatory submission sections; mentor engineers; drive standardization.

Knowledge/Skills (Required/Preferred)

• Required: packaging engineering knowledge; experience leading combination product packaging development programs; cGMP experience; strong design controls, risk/change control; ability to influence in a matrixed organization.
• Preferred/Desirable: biologics packaging systems, shipping/distribution strategies, cold chain packaging; experience with combination product development teams; governance/operating model establishment; traditional pharmaceutical packaging (e.g., OSD); NDA/BLA submission experience; CMOs; computer/organizational/project management skills.
• Working knowledge of regulations/standards (FDA, EU MDR, ISO 11607/14971, 21 CFR 210/211/820, ASTM/ISTA).

Basic Qualifications

• BS in packaging/engineering (or related) + 10+ years relevant industry experience (advanced degrees considered).

Benefits/Compensation

• Benefits include company-sponsored medical, dental, vision, and life insurance plans.