Director, Assembly and Packaging Platform Technical Leadership
Job in
Rahway, Union County, New Jersey, 07065, USA
Listed on 2026-06-17
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-06-17
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
Responsibilities
- Lead, mentor, and develop a team of technical staff; drive continuous improvement.
- Provide subject matter expertise to ensure scientific rigor, technical problem solving, and execution excellence across the assembly and packaging platform portfolio.
- Drive proactive risk management (risk assessment, mitigation, and risk communication).
- Build relationships with internal stakeholders for technical support and platform stewardship.
- Develop and maintain KPIs for effective technical platform stewardship.
- Provide strategic leadership for technical support, including managing ongoing changes and tech transfers.
- Provide technical guidance for packaging platform lifecycle changes; ensure regulatory filings and compliance.
- BS (15 yrs) / MS (12 yrs) / PhD (8 yrs) in packaging/mechanical/chemical/biochemical engineering, pharmaceutical science, chemistry, or related field; experience in pharmaceutical packaging and combination product assembly/packaging.
- Subject matter expertise in medical device and combination product commercialization and tech transfer; assembly/packaging process improvement from early stage through launch and supply.
- Leadership experience managing technical teams.
- Strong problem-solving and decision-making; ability to interrogate science and identify true requirements.
- In-depth knowledge of global regulatory requirements for medical devices and combination products.
- Risk management knowledge (e.g., ISO 14971).
- Strong strategic/analytical thinking and communications.
- Leadership, change management, GMP compliance, risk management, data-driven decision making.
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