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Scientist III, Injectable Drug Product Development

Location New Haven, Connecticut, USA Anzeigen-ID R-193630 Veröffentlichungsdatum 07/12/2024

This is what you will do:

Lead cross-functional efforts in the research, design and execution of scientific studies to enable the drug product (DP) formulation and process development, characterization, commercial validation and regulatory filing of parenteral/injectable biologic products. Lead the development of early and late stage formulation development efforts and 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. Hands on experience with bio-therapeutics drug product development, including a detailed understanding of the manufacturing unit operations is required. An understanding of protein chemistry, formulation, and biopharmaceutical assay (e.g. HPLC, CE, iCE, HIAC, MFI, etc.) development as well as the ability to run biopharmaceutical assays in a laboratory is needed. Experience in interactions with clinical teams, designing in-use compatibility studies and extractables and leachable studies is preferred.

Lead a team of associate scientists, managerial and regulatory filing experience. Involved in regulatory filing and in reviewing technical reports for early and late stage programs. Attention to detail for data review/trends and working in a fast paced multifaceted environment is expected with ability to prioritize for team and self is needed.

In addition, the candidate will provide clinical and commercial manufacturing site support including but not limited to weekly/biweekly support meetings, action item owner, and as necessary in-person on-site manufacturing support. This position is encouraged to interact regularly with cross-functional staff from Analytical Sciences, Clinical Operations, Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs.

You will be responsible for:

  • Leads DPD teams with multiple cross functional collaborators, as well as understand the cross 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 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 picture" for projects and tasks involved and prioritize work of self and others accordingly. Prioritizes multiple assigned tasks and projects and leads project teams consisting of multiple junior team members. Work independently as well as within a team.
  • Independently design and implement development studies for Alexion’s drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturing sites
  • Performed in depth data analysis as well as authors technical reports and or relevant sections of clinical and commercial regulatory filings on the implemented studies for the 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

You will need to have:

  • PhD in Chemistry, Biochemistry, Biophysics, Chemical engineering, or relevant field with 5+ years. 14+ with MS or 15 + with BS
  • Proven background in protein chemistry, chemistry, or biochemistry
  • Excellent interpersonal and communication skills are required
  • Mentor and motivate others within the department and as part of actively participating in cross-functional teams
  • Scientific and practical knowledge of protein biochemistry, protein formulation/stability, as well as bio-therapeutic drug product process development is essential
  • Hands-on experience with defining processes, scale up, transferring information between development and manufacturing sites, document preparation
  • Experience in bio-therapeutics development as well as understanding of the biotechnology products life cycle
  • Bio-therapeutics drug formulation development and analytical tools used to test formulations is a plus
  • 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 will work in a collaborative setting and enforce to timelines
  • The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees are required, 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

We would prefer for you to have:

  • Experience with electronic record keeping and data software, like electronic lab notebooks, EndNote, maintenance of laboratory instrumentation (coordinating preventative maintenance, data backup, software upgrade, etc.), as well as MS Word, PowerPoint, Excel/GraphPad, Visio, JMP/Minitab, and Adobe Pro is desirable.
  • Knowledgeable in Global Regulatory guidances, cGMPs, and Quality/Compliance expectations for the development of parenterals

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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Interessensschwerpunkte

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