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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Temperature Controlled Logistics and Packaging, with a strong focus on compliance with global regulatory requirements. Proven ability to lead cross-functional teams, manage vendor relationships, and develop operational protocols in a GMP environment.
Highest-signal resume keywords
Temperature Controlled LogisticsGMP ComplianceProject ManagementTechnical WritingLean Six Sigma/Green Belt Certification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Packaging DesignDistribution StandardsLab TestingSupply Chain ManagementRegulatory RequirementsTesting StandardsCold Chain Best PracticesOperational ProtocolsVendor ManagementShipping Qualification
Soft Skills
Analytical SkillsProblem-SolvingCommunication SkillsTeam CollaborationInterpersonal Skills
Tools & Technologies
MS ProjectMicrosoft WordPowerPointTrackwise
Certifications & Qualifications
Lean Six Sigma/Green Belt Certification
Industry Keywords
CGMPCGDP21 CFR Part 11ANVISAHealth CanadaASTMISTATemperature MonitoringLogistics3PL
About the role
Key responsibilities & impact- Lead improvement projects focused on distribution to enhance capabilities and implement new technology.
- Design, develop, and test complex distribution packaging projects from conceptual design through implementation.
- Manage external vendors and contribute to the development of distribution packaging standards.
- Draft strategies, operational protocols, and supply chain study reports for clinical and commercial programs.
- Develop test strategy for GMP products covering global regulatory requirements.
- Participate in and facilitate Supplier Relationship Management meetings and RFPs, managing vendor relationships.
- Conduct and oversee lab testing and lane validation activities internally and externally.
- Support audits, health authority inspections, and regulatory agency inquiries related to shipping qualification.
- Manage Trackwise events, CAPAs, and investigations with a focus on compliance and best practices.
- Support Global Change Controls from an SME perspective and manage activity timelines.
- Provide shipping qualification input on temperature monitoring strategies, tech transfers, and launches.
- Represent the distribution team in cross-functional meetings and provide updates to management.
- Support technical transfer and launch shipping qualification activities at internal, external, and 3PL sites.
- Provide training on cold chain best practices, guidelines, and regulations across departments.
- Maintain current knowledge of relevant cold chain requirements and monitor emerging industry trends.
- Lead weekly cross-functional shipping qualification sub-teams and participate in operational/business review meetings.
- Develop and maintain relationships with key customers and partners across Logistics, Quality, and other departments.
- Coach and provide guidance to team members, including contractors.
Requirements
What you’ll need- BS/BA degree required; BS/BA in Packaging Science/Engineering preferred.
- At least 5 years of experience in packaging, global logistics, or temperature-controlled supply chain.
- Experience in an international and regulated environment (cGMP, cGDP, 21 CFR Part 11, ANVISA, Health Canada) with knowledge of packaging standards (ASTM/ISTA) and regulations.
- Expertise in Temperature Controlled/Cold Chain Logistics, Transportation, and Packaging.
- Experience in testing standards and distribution lab environment.
- US Domestic and International experience required.
- Strong technical writing skills and strong Microsoft Word knowledge.
- Proficiency in MS Project and PowerPoint.
- Ability to present to cross-functional teams and provide succinct clear updates and information.
- Ability to develop rapport at various organizational levels.
- Experience working in a GMP environment is preferred.
- Strong analytical, problem-solving, and communication skills.
- Exceptional team player with project management experience.
- Lean Six Sigma/Green Belt certification is an asset.
- Experience with MS Project and PowerPoint.
Benefits
Comp & perks- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
- Short term and long-term incentives, including cash bonus and equity incentive opportunities