Are you ready to make a significant impact on patients' lives? As an Associate Principal Engineer/Scientist of Combination Drug Product Fill and Final Assembly, you will work with commercial drug product manufacturing sites to provide technical support for licensed products, with oversight for filling and final assembly of combination products (auto-injectors and accessorized pre-filled syringes). The position will be responsible to provide SME support during establishment of commercial product, launch and continued commercial manufacturing support, lead complex investigations and life cycle management (LCM) activities. LCM activities include providing technical input for change controls and managing complex process changes. This effort requires interactions with multidisciplinary and multisite groups, which may include technology transfer teams, external vendors, and other strategic suppliers. This role will work with both external manufacturing vendors (CMO) and internal filling/assembly sites, and will interface with relevant supply and CMC teams for commercial products. Additionally, you will be responsible for process monitoring and trending for drug product and combination product assembly related process steps.
Sites: Gaithersburg, MD or Bensalem, PA
Essential Skills/Experience and Accountabilities:
- Bachelor's degree in bio/chemical or mechanical engineering or related science degree (bio/chemistry, biotechnology, etc.).
- Minimum of 7 years of significant operational experience with Bachelors degree, 5 with advanced degree.
- Excellent problem-solving abilities.
- Strong interpersonal, organizational, collaboration, and communication skills to work well in multidisciplinary (functional) CMC teams with key other departments like Tech Transfer & Validation, Biopharmaceutical Development, Quality Assurance, Regulatory Affairs, etc.
- Experience in transferring and supporting biological combination drug product fill and final assembly production.
- Knowledge of current Good Manufacturing Practices (cGMPs), combination product regulations and guidances, and experience authoring quality management system (QMS) documents and leading involved activities: change controls, CAPAs (Corrective Actions / Preventive Actions) and deviations (investigations).
- Authoring study protocols and reports (especially Continued Process Verification (CPV), process/product monitoring), SOPs, batch records, specifications, etc.
- Identifying and implementing LCM/Continuous Improvement (CI) initiatives.
Desirable Skills/Experience:
- Fill of drug product vials.
- Manufacturing of devices like auto-injectors.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives 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.
Why AstraZeneca?
At AstraZeneca, we are driven by the challenge to stay ahead in rapidly changing markets. We continuously seek new and better ways to deliver medicines all the way to our patients. Our resilience helps us to thrive as we innovate and evolve. We foster an encouraging, positive environment where ideas are welcomed and rewarded. If you are driven, take smart risks and are able to act quickly, then this is the place for you.
Date Posted
04-Sep-2024Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.