Associate Director, Packaging Engineering
The incumbent will fulfill a strategic role within the Process Engineering and Packaging (PEP) organization. The PEP function develops clinical and commercial fill/finish processes, device/combination product assembly processes, and packaging for biopharmaceutical products in the AstraZeneca Biologics portfolio. This role is to provide packaging support for new product development teams, from clinical trials to technology transfers and new product introductions. This position requires effective collaborative interactions with multiple function groups, particularly Global Biological Operations (commercial operations), internal/external manufacturing sites within the manufacturing network and with critical partner groups (e.g. Multidisciplinary and multi-site groups, including external partners). Experience working with parental drug product fill/finish process, device/combination product development, clinical operations, supply chain, quality and regulatory are also essential. This individual must be able to work effectively in a matrix environment and be able to influence broadly internally and externally.
Major Duties and Responsibilities:
• Provide technical expertise to packaging projects in supporting Biopharmaceutical development portfolio, including packaging (carton, blister, box…) design, development, qualification and technology transfers.
• Functioning as liaison between the R&D and commercial manufacturing functions with regard to developing packaging specifications, acceptance testing and validating new packaging materials, equipment and processes.
• Author or support documentation management for Biopharmaceutical Development (BPD) policies as well as standard operation procedures, test methods, and work instructions related to packaging.
• Author or support technical documentation related to packaging design or user requirements, design verification, design/technology transfer, qualification or validation protocols and reports, specifications, technical drawings etc.
• Collaborating with packaging suppliers to ensure consistent quality and to verify supplier accountability for specifications.
• Provide packaging expertise to wide variety of business functions through project team participation (e.g. commercial, clinical supply, CMOs, and commercial operations).
B.S., M.S. or Ph.D. in Package Engineering, Packaging Science, Mechanical Engineering, Materials Science, or other relevant scientific or engineering field.
Associate Director: Bachelor’s degree and 15+ years or Master’s degree and 12+ years or Ph.D. and 7+ years of related experience in the pharmaceutical or medical device industry.
Senior Engineer: Bachelor’s degree and 10+ years or Master’s degree and 7+ years or Ph.D. and 3+ years of related experience in the pharmaceutical or medical device industry.
• Experience in operations or R&D with a track record of successful delivery with a matrix organization
• Demonstrated ability to influence cross-functionally within the organization
• Demonstrated ability to working in collaborative team environment across multiple technical functions.
• Broad and in-depth understanding of drug product packaging design and validation meeting both technical requirements as well as regulatory expectations.
• Prior experience in drug product shipping qualification (e.g. vials, prefilled syringes and autoinjectors)
• Prior experience in primary packaging, cold chain, anti-counterfeiting, temper-evidence and serialization are desirable.
• Working knowledge of testing methodologies and test standards including shock, drop and vibration tests, peel force test, barrier analysis, container closure integrity, DIN, ISO, ISTA, ASTM, USP, FDA, and EMA standards for packaging design and validation.
• Knowledge of packaging equipment and process related to drug product packaging activities and labeling systems.
• Experience in multiple disciplines in CMC and related functions (e.g. R&D, clinical supply, contact manufacturers, commercial manufacturing operations).
• Strong analytical, technical writing, verbal communication and interpersonal skills
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.