Engineer IV, Injectables Drug Product Development

    • AstraZeneca
  • New Haven, CT
  • Posted 44 days ago | Updated 11 hours ago


On Site
Full Time


Product development
Process engineering
Data processing
Technology transfer
Gap analysis
Change control
Manufacturing support
Quality control
IT service management
Quality assurance
Regulatory affairs
Chemical engineering
Life sciences
As-is process
Problem solving
Employment authorization
Analytical skill
Crystal Management Console
Good manufacturing practice
Microsoft Excel
Microsoft Outlook
Microsoft Visio
MEAN stack

Job Details

This is what you will do:

This position is responsible for leading r esearch, design and execute scientific studies to enable the drug product (DP) process development, characterization, clinical manufacturing, and commercial validation of parenteral/injectable biologic products. Lead and support e xecution of stability studies, data processing, compiling and presentation of results supporting late-stage clinical activities as well as preparation for PPQ. The candidate will support the development of a variety of manufacturing unit operations including, but not limited to, 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 lmanufacturing technology transfer activities in preparation for DS and DP PPQs , including but not limited to 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, the candidate will support deviation investigations , change controls, and CAPAs utilizing 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 as necessary in-person on-site manufacturing support. This position is expected to interact regularly with cross-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:
  • Lead the d esign and execute studies for Alexion pharmaceuticals' clinical drug candidates and commercial products, suppor t tech transfer activities for internal manufacturing and contract manufacturing sites
  • Lead progression of projects with cross functional stakeholders, as well as understand the cross functional implication of project activities and decisions with minimal supervision
  • Prioritizing multiple assigned tasks and projects independently and as part of the team
  • Contribute to the development of strategi c project plans for molecules in clinical development
  • Author SOPs, study protocols and technical reports with minimal supervision
  • Participate in cross-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.
  • Actively participate in department and team meetings including assuming ownership and delivering on assign action items
  • Develop presentations for meetings with internal and external stakeholders with minimal supervision
  • Mentor and train junior Associate Scientists and Engineers regarding drug product development
You will need to have:
  • Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, or relevant Engineering/Life Sciences field with 7 + years of relevant experience or Master's degree with 6 + years of relevant work experience
  • Self-driven initiative to find resolution for technical challenges
  • Excellent interpersonal, collaborative and communication skills
  • The duties of this role are generally 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 is preferred
  • Previous experience in biotherapeutics development as well as relevant knowledge of cGMP and Quality expectations for PPQs and BLA is preferred
  • Scientific understanding of protein stability, thermodynamics, mechanism of protein degradation, biotherapeutics 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
In-person statement for 4 days in the office:
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.