Associate Scientist IV, Injectable Drug Product Development

This is what you will do:

The Associate Scientist IV will join Injectable Drug Product Development group to support the formulation and drug product process development of Alexion's biotherapeutic candidates. This individual will develop injectable formulations with fit for purpose analytical methods, perform analytical testing, and draft reports for the executed studies. This individual will work independently in a dynamic team environment and routinely collaborate with other members of Injectable Drug Product Development as well as other groups in Product Development and Clinical Supply.

You will be responsible for:

• Execution of formulation screening and stability studies for injectable drug products including proteins, oligonucleotides, and peptides
• Building expertise in in-use and extractables and leachables assessments
• Supporting analytical method development and optimization
• Supporting development and tech transfer of GMP fill finish processes to internal and external manufacturing organizations
• Writing internal technical reports on the executed studies
• Assisting in preparation of external regulatory submissions (IND, BLA etc.) for the Alexion product candidates
• Participate in department meetings and other technical and team building activities

You will need to have:

• Extensive experience in in-use and E&L assessment across different phases of development
• Extensive experience in developing phase appropriate formulations and filling finished processes
• Working experience on various injectable dosage forms in vials, prefilled syringes/cartridges
• Comprehensive understanding of chemistry and stability, and degradation mechanism of proteins and peptides
• Excellent interpersonal and communication skills and ability to work in a collaborative setting and adhere to timelines
• Demonstrated ability to work effectively in cross-functional settings
• Hands-on experience with liquid chromatography methods (e.g. SEC, IEX, HIC) and capillary methods (e.g. iCE, LabChip GXII Touch)
• Strong knowledge of analytical software (e.g. Empower, JMP)
• Ability to interpret raw data, organize results and communicate findings to project team and management
• Understanding of the biotechnology products' life cycle and factors impacting product stability
• Lab environment physical requirements: lift/carry 15/30 pounds unassisted/assisted; work in controlled environment with biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications; problem solving and non-linear thought; collaborate with others; maintain general availability during standard business hours

We would prefer for you to have:

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