Scientist I, Injectables Drug Product Development

Alexion•New Haven, CT

1h•Hybrid

About The Position

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 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. In this role, the candidate will coordinate multi-functional initiatives in the research, creation, and implementation of scientific studies. These studies facilitate developability evaluation of biotherapeutic drug candidates. The candidate will also formulate drug products (DP), perform characterization, and validate commercial parenteral/injectable biologic products. The candidate will lead the development of drug candidates and utilization of in-silico tools in support of developability, pre-candidate selection and formulation and process development. An understanding of protein chemistry, protein engineering, formulation development as well as the ability to run computer simulations or biopharmaceutical assays in a laboratory is necessary. The candidate will establish continuous improvement systems based on lessons learned and implement these improvements in areas of developability assessment, drug formulations, manufacturing technology transfer activities as well as in-silico process simulations. This position is encouraged to interact regularly with multi-functional staff from Research, Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs.

Requirements

PhD in Chemistry, Biochemistry, Biophysics, Chemical engineering, or relevant field with 0-2 years, a MS with 9+ years or BS with 10+ years of relevant experience.
Solid background in protein chemistry, chemistry, biochemistry, or equivalent is highly preferred.
Scientific and practical knowledge of protein biochemistry, protein formulation/stability, protein engineering or protein purification as well as biopharmaceutical development is essential.
Hands-on experience with developing and utilizing computational tools for protein engineering, protein solution behavior prediction, manufacturing process design and scale-up or automation
Experience in biotherapeutics development as well as understanding of the biotechnology products life cycle
Understanding of the biotherapeutics engineering, drug development and analytical or in-silico tools used to test drug candidates or processes is desirable.
Makes strategic scientific/technical proposals based upon corporate or project objectives and has the ability to take initiative in problem solving and finding solutions to scientific challenges.
The individual must be able to work in a collaborative setting and ability to adhere to timelines is essential.
Excellent interpersonal skills are required, as is the strong ability to communicate effectively, as well as mentor and motivate others within the department and as part of actively participating in cross-functional teams.
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/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging

Nice To Haves

Experience with electronic record keeping and data software, like electronic lab notebooks, EndNote, maintenance of laboratory instrumentation (organizing preventative maintenance, data backup, software upgrade, etc.), as well as MS Word, PowerPoint, Excel/GraphPad, Visio, JMP/Minitab, and Adobe Pro, would be an advantage.
Experience with in-silico tools such as GROMACS, NAMD, BioLuminate, MOE, Python ML libraries, gPROMs or related tools
Experience with programming languages such as Python, C++, Fortran, R or related languages
Knowledgeable in Global Regulatory guidances, cGMPs, and Quality/Compliance expectations for the development of parenteral drugs

Responsibilities

Leads drug product development teams with multiple multi-functional collaborators, as well as understand the multi-functional implication of project activities and decisions on project and corporate objectives.
Makes scientific/technical proposals based on corporate or project objectives. The candidate must have the ability to communicate effectively with senior management, external partners, and/or regulatory agencies.
Actively participates in department and team meetings including assuming ownership and delivering on assign action items.
Understands "big pictures" for projects and tasks involved and prioritize work of self and others accordingly.
Prioritizes multiple work you're doing and projects and leads project teams consisting of one or more junior team members. The ability to work independently as well as part of the team is essential.
Perform in-depth data analysis.
Write technical reports and sections of clinical and commercial regulatory filings. These documents cover accomplished studies for Alexion drug product candidates.
Be current with the literature about drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations

Benefits

Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

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