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Engineer III, Injectables Drug Product Development

Location New Haven, Connecticut, USA Anzeigen-ID R-198318 Veröffentlichungsdatum 04/26/2024

This is what you will do:

This position will lead research, design and implement scientific studies to enable the drug product (DP) process development, characterization, clinical manufacturing, and commercial validation of parenteral/injectable biologic products. Lead and support execution of stability studies, data processing, compiling and presentation of results supporting late-stage clinical activities as well as preparation for PPQ. Develop a variety of manufacturing unit operations including, drug substance (DS) freeze/thaw, compounding/mixing, sterile filtration, drug product filling of vials/syringes, visual inspection, and DS/DP transportation. A general understanding of protein chemistry and/or the ability to run biopharmaceutical assays in a laboratory is preferred.

The role will lead manufacturing technology transfer activities in preparation for DS and DP PPQs, sending/receiving site process gap analysis, process FMEAs (failure mode and effects analysis), change control owner/leader, master batch record review, as well as leading at-scale/full scale process development studies, and authoring protocols, and reports. In addition, will support deviation investigations, change controls, and CAPAs using electronic Quality system. The candidate will also provide clinical and commercial manufacturing site support including but not limited to periodic meetings, action item owner, and in-person on-site manufacturing support. Interact regularly with multi-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs to support progress of the program and preparation of source documentation supporting BLA.

You will be responsible for:

  • Own the design and implement studies for Alexion pharmaceuticals’ clinical drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturing sites
  • Lead progression of projects with multi-functional collaborators, as well as understand the implications of project activities and decisions with minimal direction
  • Prioritizing multiple tasks and projects independently and as part of the team
  • Author SOPs, study protocols and technical reports
  • Participate in multi-functional development teams representing Injectable Drug Product Development
  • Maintain knowledge of current trends in drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations and scientific principles and theories. Train other peers as assigned in areas of expertise
  • Actively participate in department and team meetings including assuming ownership and delivering on assign action items
  • Develop presentations for meetings with internal and external partners

You will need to have:

  • Bachelor’s degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, or relevant Engineering/Life Sciences field with 4+ years of relevant experience or Master’s degree with 3+ years of relevant work experience
  • Dedicated initiative to find resolution for technical challenges
  • Excellent interpersonal, collaborative and communication skills
  • The duties of this role are conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video and electronic messaging; engage in problem solving and non-linear thought, analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

  • Scientific and practical knowledge of protein biochemistry and/or drug product process development
  • Previous experience in bio-therapeutics development as well as relevant knowledge of cGMP and Quality expectations for PPQs and BLA
  • Scientific understanding of protein stability, thermodynamics, mechanism of protein degradation, bio-therapeutics drug formulation development and analytical tools used to test formulations is a plus
  • High level proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPoint

Expectation of working in the office 4 days a week statement: 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 four 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!

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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