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. Specific accountabilities for this positions shall include: (1) leadership of process development and packaging for clinical combination products and devices; (2) development of robust device/combination product assembly processes for commercial production (in collaboration with Operations); (3) design transfer to both internal and outsourced commercial manufacturing; (4) development and maturation of combination products and medical device assembly development lab for technical support of clinical and commercial production. The incumbent will help oversee the process development of a diverse group biopharmaceutical dosage forms requiring a medical device component, including liquid and lyophilized formulations, novel drug delivery formulations (e.g. nanoparticles, high concentration formulations, etc.), drug delivery devices/combination product, assembly, labelling and packaging. The candidate must maintain a strong technical culture and be able to establish strong working relationships at internal and external interfaces, provide knowledgeable advice on design for manufacturing, design control, manufacturing site selection and develop and mentor junior staff in combination product process development and design transfer. This position requires effective collaborative interactions with MedImmune / AstraZeneca leaders, particularly with the Global Biological Operations (Commercial Operations) organization, 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 functions such as late stage formulation development, device/combination product development, clinical operations, supply chain, quality and regulatory are also essential. This individual must be able to effectively work in a matrix environment and be able to influence broadly internally and externally.
Major Duties and Responsibilities
- Provide technical and strategic leadership and management for the development of device assembly and packing/labeling processes for next generation medical devices/combination products, including, but not limited to add-on electronic software devices, on-body wearables, electrophorators and other novel/new devices. Scope includes accountability for design for manufacturing during feasibility activities and throughout the design controls process to commercialization, development and technical support of clinical processes, clinical packaging and support of commercial packaging, design transfer to Global Biological Operations and/or CMOs, and ad-hoc technical support for commercial production as needed.
- Apply his/her scientific and engineering knowledge/technical rigor and tools to issues and problems arising during development and execution of processes to drive resolution positively in the best interest of MedImmune/AstraZeneca and to secure product knowledge throughout development. Lead and manage functional teams, including resource management, prioritization with appropriate demand and supply oversight, critical assessment of technical work, support of project teams, and developing relationships with functional partners
- Manage and mentor junior staff and develop people to provide a group capable of meeting present and future needs. Ability to coach direct reports for enhanced individual and team performance and development ideal, but not essential.
- Ensure that delivery of SHE and cGMP compliance ensuring that all work is carried out in compliance with MedImmune / AstraZeneca and external regulatory policies and standards.
- Provide leadership and create strategies to evolve the capabilities of the organization in alignment with MedImmune strategies, growing health authority expectations, and changing external combination product/medical device competitive landscape
- Develop and transfer robust Device/Combination Product assembly, labelling and packaging processes to manufacturing site per requirements of cGMP Design Controls.
- Design and oversee process validation activities for manufacturing processes, develop risk-based characterization and process validation strategies for manufacturing processes.
- Drive a culture of innovation and high-quality science and engineering aiming to continuously improve in competence. Influence regulatory strategies and provide guidance and reviews of regulatory information packages and filings/submissions
- Challenge the status quo, yet build strong relationships and proactive engagement with functional partners
- Broadly influence and educate senior leaders and the larger MedImmune functional areas and product teams on medical device and/or combination product development and Design Transfer.
- Ensure that AstraZeneca Biologics/MedImmune is a leader in the industry by being active in the combination products and devices community through, for example, presenting at major conferences, participation in industry consortiums, etc.
B.S., M.S. or Ph.D. in Mechanical Engineering, or other relevant Engineering field, Materials Science, or related fieldSenior Manager
: Bachelors degree and 13+ years OR Masters degree and 10+ years OR Ph.D and 3+ years of related experience in the biopharmaceutical or medical device industry.Senior Scientist:
Bachelors degree and 15+ years OR Masters degree and 13+ years OR Ph.D and 7+ years of related experience in the biopharmaceutical or medical device industry.
Strong technical and scientific skills with proven experience in development of drug product and/or combination product manufacturing processes for biologics in primary containers and devices.Requirements
Next Steps - Apply today!To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
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- Candidate must be an established industry leader in combination products or medical device process development
- 1+ years managerial experience preferred, but not required
- Must possess in depth knowledge developing and executing strategies for device/combination product process development
- Must have strong knowledge of design for manufacturing
- Experience with regulatory agency interactions
- Demonstrated ability to influence cross-functionally within the organization
- Demonstrated ability to work in a collaborative team environment across multiple technical functions
- Must have a strong, broad understanding of industry scientific and technical advancements in medical device and/or combination product manufacturing process development
- Have a thorough understanding of principles, applications and management of cGMP and risk management per requirements of medical device Design Controls.
- Experience in Operations and/or R&D with a track record of successful delivery within a matrix organization
- Experience in, or exposure to, multiple disciplines in CMC and related functions (e.g. R&D and Contract Manufacturers).
- Position is based in Gaithersburg, MD.