This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Associate Director, Technical Operations (Pharmaceutical Packaging) based in the United States.
This senior technical operations role sits at the intersection of pharmaceutical packaging engineering, product development, and global supply chain execution. The Associate Director will serve as the packaging subject matter expert, guiding the design and lifecycle management of packaging systems for combination products in the rare disease space. The role spans clinical development through full commercialization, ensuring packaging solutions protect product integrity while meeting stringent global regulatory and operational requirements. Working in a highly collaborative, cross-functional environment, this position partners with Quality, Regulatory, Supply Chain, and Commercial teams to enable successful product launches and ongoing lifecycle improvements. It is both a strategic and hands-on leadership role, influencing packaging innovation, compliance, and patient-centric design. The environment is fast-paced, science-driven, and mission-focused on delivering meaningful therapies to patients with rare diseases.
Accountabilities:
- Lead the design, development, and finalization of pharmaceutical packaging systems, including primary and secondary packaging, labels, cartons, shippers, and ancillary components, ensuring patient usability, product protection, and regulatory compliance.
- Oversee packaging engineering activities such as specifications development, component selection, material compatibility, and documentation of packaging drawings, bills of materials, and instructions.
- Drive packaging innovation, including sustainable materials and human factors–driven designs that support patient adherence and usability.
- Lead packaging technology transfer from development to clinical and commercial manufacturing, ensuring seamless implementation with external partners and CPOs.
- Manage packaging qualification and validation activities, including transportation simulation studies, distribution qualification, and cold chain shipping validation.
- Ensure serialization, traceability, and labeling compliance across global regulatory frameworks, including DSCSA and other applicable requirements.
- Support quality and regulatory activities including audits, inspections, deviation investigations, CAPA, change control, and regulatory submissions related to packaging systems.
- Oversee lifecycle management of packaging systems, including continuous improvement, optimization, and post-launch updates.
Requirements:
- Bachelor’s or Master’s degree in Packaging Engineering, Mechanical Engineering, Chemical Engineering, Industrial Design, or a related technical field; advanced degree preferred.
- Minimum of 8+ years of experience in pharmaceutical, biotech, or medical device packaging, including clinical and commercial environments.
- Proven experience in packaging design, validation, qualification, and technology transfer within regulated environments.
- Strong understanding of pharmaceutical packaging systems, including sterile barrier systems, cold chain logistics, and distribution requirements.
- Deep knowledge of cGMP, FDA, EMA, and global regulatory requirements, including labeling and serialization standards.
- Experience working with Contract Packaging Organizations (CPOs) and managing external manufacturing partnerships.
- Familiarity with DSCSA requirements and global serialization/traceability systems.
- Strong analytical, problem-solving, and decision-making skills with high attention to detail.
- Excellent communication, collaboration, and stakeholder management abilities in a cross-functional environment.
- Ability to manage multiple priorities in a fast-paced, evolving development-to-commercialization setting.
- Six Sigma or statistical process knowledge is a plus.
- Willingness to travel domestically and internationally (10–20%).
Benefits:
- Competitive compensation package including base salary, short-term incentives, and long-term equity participation.
- Comprehensive health coverage, including medical, dental, and vision plans for employees and eligible dependents.
- Retirement savings plan with employer matching contributions.
- Generous paid time off and flexible work arrangements supporting work-life balance (remote eligible role).
- Life, disability, and financial protection insurance programs.
- Employee wellness programs and mental health support resources.
- Professional development opportunities within a high-growth, mission-driven environment.
- Exposure to global, cross-functional projects in advanced pharmaceutical packaging and rare disease therapeutics.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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