3 open positions available
Manage inventory systems, mentor staff, and collaborate across functions to optimize logistics processes. | Requires 3+ years of experience in logistics or related fields, proficiency in ERP systems like SAP, and strong project management skills. | Job Title: Logistics Packaging Specialist II Location: Rahway, NJ Work Environment: Hybrid (onsite 3 days a week) Job Summary: The Logistics Packaging Specialist II is responsible for driving tasks to completion and mentoring junior staff. This role requires a heightened level of autonomy and strong business acumen. Key Responsibilities: • Drive tasks to completion amidst ambiguity. • Mentor junior staff and provide guidance on project management. • Collaborate across functions to achieve business objectives. • Develop and implement a formal inventory control program in our distribution centers. • Act as a strategic partner and liaison between external vendors and internal stakeholders. • Develops and implements strategies to simplify process, improve accuracy, and improve operating efficiency. • Manage and provide appropriate direction and support to team members to ensure effectiveness and efficiency of inventory controls systems and procedures. • Review and understand growth forecast opportunities to build long-term strategic plans. • Manage third-party warehouse inventory. • Optimizing inventory, asset, and safety stock management. • Support the year-end PO process so that suppliers have timely purchase orders for uninterrupted supplies. • Preparation of forecasts and reports. • Partner with distribution planning and logistics to forecast demand. • Partner with finance team and provide analytics. • Develop and execute thermal qualification protocols for controlled temperature shippers and microenvironments. • Operate and maintain data acquisition systems and validation testing instruments including the Kaye Validator and wireless data loggers. • Explore new packaging technologies and monitoring devices that improve company's ability to deliver products to patients around the world. • Plan and execute thermal mapping studies for controlled temperature shippers. Qualifications: • Bachelor's degree preferred; candidates with relevant experience may be considered. • 3+ years of experience in a related field; candidates without a degree should have 6+ years of relevant experience. General Skills: • Strong communication and project management skills. • Ability to collaborate across functions and teams. • Analytical thinking and problem-solving skills. • Strong process management foundation (e.g., Lean, Six Sigma, Value Stream Mapping) and demonstrated ability to mobilize these skills. • Proficiency in SAP, MS Power Tools, report preparation, and data analysis. • Experience utilizing an ERP (e.g., SAP, JDE, etc.) Unique Responsibilities: • Ability to make connections at a higher level within the function. • Self-motivated with the ability to mentor others.
Lead daily operations of a chemical manufacturing unit, manage teams, ensure quality and safety standards, and drive process improvements. | Bachelor's in Chemical Engineering or related field, 5+ years in chemical manufacturing, leadership experience, knowledge of process equipment and quality systems. | Kelly Engineering is seeking a DIRECT HIRE - Unit Operations Manager to join one of our leading clients in the Chemical Manufacturing industry at their Georgetown, SC location. Please apply to learn more! Ideal Candidate: • Bachelor’s degree in Chemical Engineering, Chemistry, or related technical field strongly preferred (equivalent experience considered). • 5+ years of hands-on experience in industrial chemical manufacturing; prior leadership or supervisory experience highly desired. • In-depth knowledge of chemical processing equipment and utilities (reactors, dryers, conveyors, hot oil systems, chillers, cryogenic systems, heat exchangers, etc.). Key Responsibilities • Lead daily operations of a chemical manufacturing unit with full accountability for production volume, team performance, and product quality. • Directly manage a team of 20+ operators and technicians in a fast-paced batch production environment producing powder thickeners. • Ensure consistent compliance with ISO 9001, internal quality systems, and customer specifications. • Oversee and optimize hands-on operate reactors, dryers, hoppers, conveying systems, packaging lines, and utility systems (hot oil, chillers, cryogenic units, heat exchangers). • Drive process optimization using SPC, SQC, and Gantt-based production tracking. • Lead root-cause investigations and corrective/preventive actions (OOS, CAPA, and deviation events. • Champion continuous improvement initiatives in efficiency, cost reduction, yield, and 5S/housekeeping standards. • Collaborate cross-functionally with Quality Assurance, Engineering, EHS, R&D/Technology, Logistics, and Maintenance teams. • Actively participate in Management of Change (MOC), HAZOP studies, and plant safety programs. • Develop team members through training, performance evaluations, and accountability measures. Qualifications • Bachelor’s degree in Chemical Engineering, Chemistry, or related technical field strongly preferred (equivalent experience considered). • 5+ years of hands-on experience in industrial chemical manufacturing; prior leadership or supervisory experience highly desired. • In-depth knowledge of chemical processing equipment and utilities (reactors, dryers, conveyors, hot oil systems, chillers, cryogenic systems, heat exchangers, etc.). • Proven track record with ISO 9001 quality systems and regulatory compliance (OSHA, EPA, etc.). • Demonstrated ability to lead teams, troubleshoot in real time, and deliver results in a high-output manufacturing setting. • Experience with process optimization tools (SPC/SQC), preventive maintenance programs, and cross-functional collaboration. Location & Schedule • Full-time onsite role at our chemical manufacturing campus in Georgetown, South Carolina (Beautiful coastal location between Charleston and Myrtle Beach) • Monday–Friday schedule, 40+ hours/week • On-call availability required to support 24/7 production needs
Lead and modernize the Internal Audit Program with risk-based GMP audits, manage vendor qualification and compliance, and collaborate cross-functionally to ensure inspection readiness and continuous quality improvement. | Bachelor’s degree in Life Sciences, 8+ years in pharma/life sciences with 5+ years in GMP auditing/vendor management, strong knowledge of global GMP regulations, CSV and data integrity auditing experience, and ability to lead programs and influence stakeholders. | Lead Auditor / Assistant Director, GMP Quality Systems Workplace: Carlsbad, CA (on-site preferred) or remote (quarterly travel required, expenses covered) Salary range: $100,000–$140,000 + 15% performance bonus + equity (RSUs & stock options) About the Company Our client is a commercial-stage biotechnology company recognized for pioneering RNA-targeted medicines and advanced gene technologies. With multiple approved therapies, a robust pipeline, and a shift toward commercial GMP operations, the company is expanding its Quality Systems team to ensure global inspection readiness and regulatory excellence. Position Overview We’re seeking an experienced GMP Auditor to step into a strategic Assistant Director-level role within our Quality Systems and Vendor Management team. Reporting to the Director of GxP Quality Systems, you will own and elevate the Internal Audit Program while supporting GMP vendor management. This is a high-impact, individual contributor role—ideal for someone who thrives on leadership through influence, program ownership, and cross-functional collaboration. Key Responsibilities • Lead and modernize the Internal Audit Program: • Conduct risk-based audits of internal GMP functional areas. • Transition the program beyond compliance checks to a holistic, risk-driven model. • Ensure inspection readiness for commercial operations. • Conduct hands-on audits with emphasis on: • Computer System Validation (CSV) & Data Integrity • Drug product fill/finish processes • Combination products (e.g., auto-injector assembly) • Vendor Management: • Perform GMP vendor qualification, ongoing audits, and performance monitoring. • Oversee Quality Agreements, Change Notifications, and vendor-related CAPAs. • Partner with stakeholders to drive vendor compliance and continuous improvement. • Stakeholder Collaboration: • Work cross-functionally with QA, manufacturing, and global quality partners. • Influence teams to recognize risks, strengthen systems, and drive enhancements. • Quality Leadership: • Demonstrate ownership, initiative, and strong communication skills. • Serve as a quality culture ambassador—driving agility, compliance, and continuous improvement. Qualifications Required: • Bachelor’s degree in a Life Sciences field (Chemistry, Biology, Biotech, Engineering, etc.). • 8+ years’ experience in life sciences or pharma, with at least 5 years focused on GMP auditing/vendor management. • Strong knowledge of global GMP regulations (FDA, EMA/Eudralex, ICH, MHRA, Health Canada, etc.). • Proven experience with CSV audits, data integrity, and drug product fill/finish. • Ability to lead programs independently, influence stakeholders, and communicate effectively at all levels. • Track record of working in mid-to-large pharma/biopharma environments (preferred over small biotech only). Preferred: • Experience with antisense oligonucleotide manufacturing. • Exposure to combination product/device assembly. • Familiarity with electronic audit systems (e.g., TrackWise, Veeva). • Continuous improvement mindset with demonstrated program-building skills. • Why Join Us • Be part of a growing Quality Systems team shaping the company’s commercial readiness. • Work in a collaborative, global, and innovative environment with colleagues across the U.S. and Europe. • Competitive compensation package: base + annual bonus + equity. • Flexibility: onsite in Carlsbad preferred, but remote considered for strong candidates (quarterly travel required, fully covered).
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