Scientist I, Injectable Drug Product Development

This is what you will do:

The Scientist I will join Injectable Drug Product Development group to lead cross-functional efforts to enable the development of Alexion’s injectable products in the pipeline. This individual will develop phase appropriate formulationand manufacturing process with a detailed understanding of biotherapeutic drug product degradation pathways and key fill finish manufacturing unit operations. This individual will perform analytical assays in a laboratory with an understanding of protein chemistry and biopharmaceutical assay. This individual will work independently and collaboratively in a dynamic team environment and routinely collaborate with other members of Injectable Drug Product Development team as well as other groups within Product Development and Clinical Supply. 

You will be responsible for:

• Lead Drug Product development team with execution of formulation screening and stability studies for injectable drug products including proteins, oligonucleotides, and peptides. 

• Supporting process development and tech transfer of GMP fill finish processes to internal and external manufacturing organizations.

• Supporting analytical method development and optimization 

• 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 cross-functional meetings and contribute to drive CMC deliverables

• Participate in department meetings and other technical and team building activities

You will need to have:

• PhD in Chemistry, Bio Chemistry, Biophysics, Chemical engineering, or relevant fieldwith0-2 years of relevant experience, a MS with 6+ years or BSwith8+ years of relevant experience.

• Extensive experienceon developing phase appropriate formulations and fill finish processes.

• Working experience on various injectable dosage forms in vials, prefilled syringes/ cartridges.

• Comprehensive understanding of chemistry and stability, and degradationmechanism of proteins and peptides. 

• Ability to work in a collaborative setting and adhere to timelines.

• Demonstrated ability to work effectively in a cross-functional settings. 

• Hands-on experience with liquid chromatography methods (e.g., SEC, RP, IEX, HIC) and capillary methods (e.g.iCE, LabChip GXII Touch).

• Strong knowledge of analytical software (e.g. Empower).

• Ability to interpret raw data, organize results and communicate findings to project team and management

• The duties of this role are generally conducted in an 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/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Experience with electronic record keeping and data software, like electronic lab notebooks, EndNote, as well as MS Word, PowerPoint, Excel/GraphPad, Visio, JMP/Minitab, and Adobe Pro, would be an advantage. 

• Excellent interpersonnel and communication skills.

• Understanding of the biotechnology products life cycle and factors impacting product stability.

• Understanding the principle of risk assessments.

• Knowledge of cGMP and quality guidelines.