Engineer IV, Injectables Drug Product Development

This is what you will do:

This position is responsible forleadingresearch, design and execute scientific studies to enablethe 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. The candidatewill support the development of a variety of manufacturing unit operations including,but not limited to, drug substance (DS) freeze/thaw, compounding/mixing, sterilefiltration, drug product filling of vials/syringes, visual inspection, and DS/DPtransportation. A general understanding of protein chemistry and/or the ability to runbiopharmaceutical assays in a laboratory is preferred.

The role will lead manufacturing technology transfer activitiesin 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 supportincluding but not limited toperiodic meetings, action item owner,and as necessary in-person on-site manufacturing support. This position is expectedto interact regularly with cross-functional staff from Analytical Sciences & QualityControl, Drug Substance Process Development, Manufacturing Technical Services,Quality Assurance, and/or CMC Regulatory Affairstosupport progress of the program and preparation of source documentation supporting BLA.

You will be responsible for: 

• Lead the design and execute studies for Alexion pharmaceuticals’ clinical drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturingsites

• Lead progression of projects with cross functionalstakeholders, as well as understand the cross functional implication of projectactivities and decisions with minimal supervision

• Prioritizing multiple assigned tasks and projects independently and as part of the team

• Contribute to the development of strategic project plans for molecules in clinical development 

• Author SOPs, study protocols and technical reportswith 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 assumingownership 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.