Associate Scientist IV, Injectable Drug Product Development

Alexion • New Haven, CT

6d

About The Position

The Associate Scientist IV will join the Injectable Drug Product Development group and support formulation and drug product process development for Alexion biotherapeutic candidates. The role develops injectable formulations with fit-for-purpose analytical methods, performs analytical testing, and drafts reports on executed studies. The individual works independently in a dynamic team environment and collaborates with Injectable Drug Product Development, Product Development, and Clinical Supply colleagues.

The duties are generally conducted in a laboratory environment. Employees must be able, with or without accommodation, to lift or carry 15 pounds unassisted or 30 pounds assisted; work in a controlled environment around biological, infectious, and hazardous materials; gown and degown PPE; use a computer; communicate by phone, video, and electronic messaging; engage in problem solving and analysis; collaborate with others; and maintain general availability during standard business hours.

Requirements

• Extensive experience in in-use and E&L assessments 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, ability to work collaboratively, and ability to 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 biotechnology product life cycles and factors affecting product stability.
• Ability to work in a controlled laboratory environment around biological, infectious, and hazardous materials and to gown and degown PPE.
• Ability to lift or carry 15 pounds unassisted or 30 pounds assisted, with or without accommodation.
• Ability to use a computer, communicate through phone, video, and electronic messaging, collaborate, and maintain general availability during standard business hours.

Nice To Haves

• BS or MS degree in Biochemistry, Chemistry, Chemical Engineering, or a related discipline from an accredited university; the posting associates 6+ years of experience with an MS and 7+ years with 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 (E&L) 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 in preparing external regulatory submissions, including INDs and BLAs, for Alexion product candidates.
• Participate in department meetings and technical and team-building activities.

What This Job Offers

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