Associate Scientist IV, Injectable Drug Product Development

AstraZeneca • New Haven, CT

8d

About The Position

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

The work is generally conducted in a laboratory environment. The role involves working with biological, infectious, and hazardous materials in a controlled environment, wearing and removing PPE, using a computer, communicating by phone, video, and electronic messaging, and collaborating in problem solving and analysis. Employees must maintain general availability during standard business hours. The position requires the ability, with or without accommodation, to lift or carry 15 pounds unassisted or 30 pounds assisted.

Requirements

• Extensive experience in in-use and E&L assessment across different development phases.
• Extensive experience developing phase-appropriate formulations and fill-finish processes.
• Work experience with injectable dosage forms in vials and prefilled syringes or cartridges.
• Comprehensive understanding of the 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 that affect product stability.
• Ability, with or without accommodation, to lift or carry 15 pounds unassisted or 30 pounds assisted; work in a controlled environment with biological, infectious, and hazardous materials; gown and degown PPE; use a computer; communicate via phone, video, and electronic messaging; problem-solve and engage in analysis and dialogue; 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.
• Six or more years of experience with an MS degree, or seven or more years with a BS degree.
• 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 other technical and team-building activities.

What This Job Offers

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