Associate Scientist IV, Injectable Drug Product Development

AstraZeneca • New Haven, CT

4d

About The Position

The Associate Scientist IV will join the Injectable Drug Product Development group to support formulation and drug product process development for Alexion’s biotherapeutic candidates. The role involves developing injectable formulations and fit-for-purpose analytical methods, performing analytical testing, and drafting reports on completed studies. The individual will work independently in a dynamic team environment and collaborate with colleagues in Injectable Drug Product Development and other Product Development and Clinical Supply groups.

The position’s duties are generally conducted in a laboratory environment. Employees must be able, with or without accommodation, to meet the described physical and work requirements, including lifting and carrying 15 pounds unassisted or 30 pounds assisted; working in a controlled environment around biological, infectious, and hazardous materials; and wearing and removing PPE. The role also requires computer use, communication through phone, video, and electronic messaging, problem solving and analysis, collaboration, and general availability during standard business hours.

Requirements

• Extensive experience in in-use and extractables and leachables assessment across different development phases.
• Extensive experience developing phase-appropriate formulations and fill-finish processes.
• Working experience with injectable dosage forms in vials, prefilled syringes, and cartridges.
• Comprehensive understanding of chemistry, stability, and degradation mechanisms of proteins and peptides.
• Excellent interpersonal and communication skills, with the ability to work collaboratively and adhere to timelines.
• Demonstrated ability to work effectively in cross-functional settings.
• Hands-on experience with liquid chromatography methods such as SEC, IEX, and HIC, and capillary methods such as iCE and LabChip GXII Touch.
• Strong knowledge of analytical software such as Empower and JMP.
• Ability to interpret raw data, organize results, and communicate findings to project teams and management.
• Understanding of the biotechnology product life cycle and factors affecting product stability.

Nice To Haves

• BS or MS degree in Biochemistry, Chemistry, Chemical Engineering, or a related discipline from an accredited university, with 6+ years of experience for an MS or 7+ years for a BS.
• Knowledge of cGMP and quality guidelines.

Responsibilities

• Execute formulation screening and stability studies for injectable drug products, including proteins, oligonucleotides, and peptides.
• Build expertise in in-use and extractables and leachables assessments.
• Support analytical method development and optimization.
• Support development and technology transfer of GMP fill-finish processes to internal and external manufacturing organizations.
• Write internal technical reports on executed studies.
• Assist with preparation of external regulatory submissions, including INDs and BLAs, for Alexion product candidates.
• Participate in department meetings and other technical and team-building activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed