Director Process Engineering & Packaging

Gaithersburg, MD, United States

Job Title: Director Process Engineering & Packaging

Location: Onsite with flexibility in Gaithersburg MD

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

About AstraZeneca in Gaithersburg, MD:

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern, vibrant scientific campus is the home of R&D and Oncology in the US.

The Gaithersburg site provides offerings in a wide variety of people centered amenities to help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria. On our campus you will find newly-designed, activity-based work spaces to suit a variety of working preferences.

Position Summary

The incumbent will fulfill a strategic leadership role within the Process Engineering and Packaging (PEP) organization. The PEP function develops clinical and commercial fill/finish processes, combination product assembly processes, and packaging for biopharmaceutical products in the AstraZeneca portfolio. Specific accountabilities include:leadership of process development for late-stage clinical products;development of robust drug product processes for commercial production (in collaboration with Operations);technology transfer to both internal and outsourced commercial manufacturing;development and maturation of an advanced scale-down fill/finish development lab for technical support of clinical and commercial production.

The incumbent will help lead all aspects of the process development and technology transfer of a diverse group of biopharmaceutical dosage forms, including liquid and lyophilized formulations, various primary container formats, with specific focus on late stage biologics pipeline. The incumbent must maintain a strong technical team and establish strong working relationships with internal and external interfaces. This position requires effective collaborative interactions with AstraZeneca leaders, particularly with the Global Biological Operations (Commercial Operations) organization and internal/external manufacturing sites within the manufacturing network. Experience working with functions such as late stage formulation development, device development, clinical operations, supply chain, quality and regulatory are critical for success. This individual is expected to effectively lead in a matrix environment and be able to influence broadly internally and externally.

Major Duties and Responsibilities

Provide technical and strategic leadership of drug product processes for late stage programs. Scope includes management of and accountability for: development and technical support of clinical and commercial Drug Product processes, technology transfer to internal and outsourced manufacturing and ad-hoc technical support for commercial production as needed

Leads Drug Product and/or CMC functional teams, including resource management, prioritization, critical assessments. project team support, and relationship development w functional partners

Lead business process, operations and technology initiatives to improve project execution and efficiency; drive a culture of innovation - high-quality science based engineering

Manages, coaches and develops and staff creating strategies to evolve the capabilities of the organization aligned with AstraZeneca growth strategies

Influence regulatory strategies ie. standardized submissions and provide oversight and reviews of regulatory information packages and filings/submissions

Broadly influence and educate senior leaders and the larger AstraZeneca functional areas and product teams on drug product development

Create solid partnerships with key interfaces and represent BPD on senior leadership teams, committees and councils

Champion sustainability initiatives within PEP to meet AstraZeneca’s carbon-negative ambition

Education, Experience and Skill Requirements

BS + 13 yrs experience; or MS + 10 yrs experience; or PhD + 7 yrs experience

Field of study Chemical Engineering or other relevant Engineering field or Pharmaceutical Sciences

Related experience in the biopharmaceutical industry

Strong technical and scientific skills with proven experience in development of drug product manufacturing processes for biologics in primary containers and devices.

Must have a strong, broad understanding of industry scientific and technical advancements in drug product manufacturing process development

Candidate must be recognized leader in drug/combination product development possessing in depth knowledge developing and driving strategies for drug product process development

Experienced in CMC aspects of biopharmaceutical development

Experience with regulatory agency interactions and author/review of regulatory filings/submissions

Demonstrated ability to lead / influence multi-functionally and at a senior level within the organization, including direct experience influencing and working with senior leaders

Demonstrated ability to effectively lead and develop professional staff, and work in a collaborative team environment across multiple technical functions

AstraZeneca an Employer of Choice

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together.

We offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a comprehensive benefits package! If you have the determination to create a culture of courageous leadership, creativity and collaboration, we want to hear from you!

AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or parental 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. We believe that the more inclusive we are, the better our work will be.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. We are eager to know more about you. If you are interested in learning more about us, apply now!

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 authorization and employment eligibility verification requirements.

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