Gilead Sciences, Inc.
* Lead the development and qualification of **primary, secondary, and tertiary packaging systems** for oral solids, parenteral, biologics, and combination products.* Apply advanced principles related to **container closure systems (CCS)** and **drug/device secondary packaging**, ensuring robust design and operational performance.* Manage packaging activities across**clinical development and commercialization**, ensuring timely execution and compliance with **cGMP** and regulatory standards.* Manage **material selection**, component characterization, and qualification of packaging systems and equipment.* Execute **equipment and process qualification**(IQ/OQ/PQ) for packaging configurations and manufacturing sites.* Design and author **packaging study protocols and technical reports** to support product development, stability, and regulatory submissions.* Draft and review **Standard Operating Procedures** (**SOPs)** related to packaging development and departmental functions, ensuring alignment with broader organizational policies.* Contribute to **global regulatory filings** by authoring packaging-related sections for INDs, NDAs, BLAs, and other submissions.* Collaborate cross-functionally with **Regulatory, Quality, Supply Chain, Device Engineering**, and external partners to develop and implement optimal packaging solutions.* Monitor **industry trends**, emerging technologies (e.g., sustainable packaging), and evolving regulatory requirements.* Participate in **standards organizations** (e.g., USP, ISO, ASTM, ISTA) and contribute to internal packaging policy development.* Demonstrate **familiarity with temperature-controlled shipping container qualification**, including ISTA 7D methodology and supplier engagement.* Lead or contribute to**strategic initiatives** aimed at enhancing packaging capabilities and compliance.* **Mentor** or manage junior packaging engineers and serve as a technical lead on cross-functional teams.* Train new employees on SOPs, documentation systems, and packaging best practices.* Support packaging operations by resolving **deviations and investigations** in collaboration with Quality and Operations.* Initiate and manage **change controls** related to packaging systems and documentation.* Travel up to **20%** may be required to support external site activities and supplier collaboration.- Support **combination product packaging**, demonstrating familiarity with **design controls**, risk management, and applicable regulations (e.g., 21 CFR Part 4, ISO 11607).* Strong technical expertise in **packaging engineering and development methodologies**, with experience across biologics and traditional pharmaceutical dosage forms (e.g., oral solids, powders, suspensions, small molecules, and parenterals).* Familiarity with **combination product packaging**, including applicable regulatory requirements and **design control principles**.* Working knowledge of **FDA, cGMP**, and global regulatory guidance related to **container closure systems** and **temperature-controlled packaging**.* Proven ability to collaborate with **external suppliers**, **contract manufacturing organizations (CMOs)**, and contract test laboratories.* Strong **written, verbal, and interpersonal communication skills**, with the ability to clearly document and present technical work.* Proficient in **project management**, organizational planning, and use of relevant software tools for documentation and analysis.* Demonstrated ability to exercise **sound engineering judgment** in a fast-paced, dynamic environment.* Experience supporting packaging activities at **pharmaceutical CMOs** is highly desirable.* Doctorate OR* Master’s and 4+ years of relevant experience in a cGMP-related industry OR* Bachelor’s and 6+ years of relevant experience in a cGMP-related industry* Degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field* Proven experience in a **cGMP-compliant environment**, with a strong understanding of regulatory expectations for pharmaceutical and biologics packaging.* Hands-on experience in **packaging development for injectable biologics, combination products**, and **temperature-sensitive pharmaceuticals**.* Familiarity with **TAPPI**, **ISTA**, and **ASTM** standards for packaging materials and systems, including mechanical and environmental testing protocols.* Demonstrated experience with **CAD-based packaging assembly drawings**, development of **protective and user-friendly secondary packaging features**, and implementation of **moisture barrier packaging solutions** for sensitive pharmaceutical and biologic products.* Experience using **electronic documentation systems** such as **Veeva** and **TrackWise** for managing quality and regulatory documentation.* Prior involvement in **shipping qualification** for biologic and combination products, including **thermal and mechanical validation**. Experience supporting **technology transfer**, **component qualification**, and **design history file (DHF)** development, including **design inputs**, **verification**, **validation**, and **human factors engineering (HFE)** in alignment with **FDA and ISO standards**.* Active participation in professional organizations (e.g., **PDA**, **ISPE**, **IoPP**) or contributions to industry publications and conferences.* Experience leading or contributing to **sustainable packaging initiatives**, including material selection, recyclability, and life cycle assessments (LCA).
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