Scientist III, Injectable Drug Product Development

AstraZeneca • New Haven, CT

5d • Onsite

About The Position

Interpret complex datasets and translate findings into formulation composition, technical reports, process parameters, control strategies, and regulatory filings.
Interact regularly with cross-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Device Development, Manufacturing Technical Services, Quality Assurance, and CMC Regulatory Affairs.
You will be responsible for:
Leading phase appropriate formulation and process development for injectable biologics, translating program goals into experimental plans, decision criteria, timelines, and risk mitigation from candidate selection through commercial validation and filings.
Designing, executing, and troubleshooting laboratory studies using advanced biophysical and analytical methods, with hands on responsibility for high quality data generation.
Defining and optimizing drug product processes (fill/finish relevant unit operations, viscosity management, filtration, mixing, hold steps), conducting scaleup and robustness studies, and supporting technology transfer to internal and external manufacturing sites.
Integrating complex datasets to establish structure–function relationships, degradation pathways, and mechanism informed stress models; translating insights into robust formulations, control strategies, and phase appropriate specifications.
Authoring protocols, technical reports, and contributing to CMC sections of regulatory submissions, including comparability assessments and responses to regulatory queries.
Cross functional collaboration with to align development plans and ensure timely program delivery.
Mentoring junior team members in matrix teams; reviewing study designs and data; promoting experimental rigor and documentation excellence.
Work with senior management, partners, and cross functional teams; presenting program status, risks, and recommendations; taking initiative to solve scientific and operational challenges.

Requirements

• PhD in Chemistry, Biochemistry, Biophysics, Chemical engineering, or relevant field with 5 years of proven experience
• MS with 14 years or BS with 15+ years of proven experience.
• Excellent interpersonal skills
• Ability to mentor and empower others within the team and cross-functionally.
• Scientific and practical knowledge of protein biochemistry, protein formulation, and stability.
• Make strategic scientific/technical proposals based upon corporate or project objectives and can take initiative in problem solving and finding solutions to scientific challenges.
• 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

• Electronic record keeping and data software, (electronic lab notebooks, EndNote)
• Maintenance of laboratory instrumentation (prioritizing preventative maintenance, data backup, software upgrade, etc.), as well as MS Word, PowerPoint, Excel/GraphPad, Visio, JMP/Minitab, and Adobe Pro.
• Knowledgeable in Global Regulatory guidance, cGMPs, and Quality/Compliance expectations for the development of parenterals.
• Validated background in protein chemistry, chemistry, biochemistry, or equivalent.
• Hands-on experience with process development, scale up, and tech transfer to manufacturing sites.
• Expertise in AUC

Responsibilities

• Leading phase appropriate formulation and process development for injectable biologics, translating program goals into experimental plans, decision criteria, timelines, and risk mitigation from candidate selection through commercial validation and filings.
• Designing, executing, and troubleshooting laboratory studies using advanced biophysical and analytical methods, with hands on responsibility for high quality data generation.
• Defining and optimizing drug product processes (fill/finish relevant unit operations, viscosity management, filtration, mixing, hold steps), conducting scaleup and robustness studies, and supporting technology transfer to internal and external manufacturing sites.
• Integrating complex datasets to establish structure–function relationships, degradation pathways, and mechanism informed stress models; translating insights into robust formulations, control strategies, and phase appropriate specifications.
• Authoring protocols, technical reports, and contributing to CMC sections of regulatory submissions, including comparability assessments and responses to regulatory queries.
• Cross functional collaboration with to align development plans and ensure timely program delivery.
• Mentoring junior team members in matrix teams; reviewing study designs and data; promoting experimental rigor and documentation excellence.
• Work with senior management, partners, and cross functional teams; presenting program status, risks, and recommendations; taking initiative to solve scientific and operational challenges.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees