Introduction to role:

The Development Scientist III position is a technical position responsible for development, qualification, andoptimization of bioassay(biological activity/potencyassayof drug candidates)andprocess-derivedimpuritymethods(HCP, residual Protein A,residualDNA), in order to supportrelease and stability testing of biotherapeutic products, and also formulation and process development.This position also supports regulatory filing (IND and BLA) and responsesto HealthAuthoritiesqueries.Participation inmethodstransfer,validation,troubleshooting and investigations ofbioassay andimpurity methods to internal and external laboratories may be required.In addition, this position is expected to interact regularly with other functional areas, such as Research,Biologic Drug Substance Development, and InjectableDrug Product Developmentgroups as well as Manufacturing, Quality Assurance and Quality Control groups.

Accountabilities:

• Development,optimization,and phase-appropriatequalificationofbioassays to evaluate quantitativebiological,biochemical,and cellularactivitiesfortherapeuticproteins.

• Responsiblefor phase-appropriate qualification forprocess-derived impurity methodsand impurity work strategyto support process development, product releasespecification,andregulatoryfiling.

• Makes scientific/technical proposals of strategic nature based on corporate or projectobjectivesandunderstands the impact of their decisions on corporate/projectobjectives.

• AuthorsSOPs, study plans, protocols, method development/qualificationreports.Draftscorresponding IND and BLA sections for regulatory filingandauthors responses to health authority queries and requests.

• Leads cross-functional scientific/technical problem-solving efforts. Carries out authentic, persuasive scientific/technical presentations of strategic nature incross-functionalenvironment.

• Assistswith prioritizing technical work efficiently to meet projecttimelines.

• Strong ability to multi-task and achieve milestone deliverables across multipleprojects.

• Explores newinnovativetechnologies and automation to improvethroughputand efficiency ofbioassay andimpuritymethods.

• Establishcontinuous improvement systems based on lessonslearned andincorporateimprovements into ways of doingbusiness.

• Positively contributes to improving the workingenvironment andengaged in on-going Alexion cultural improvementefforts.

Required Skills and Education:

• Ph.D. ormastersdegree in Biochemistry, Molecularand CellularBiology, Immunology, Chemistry, Bioengineering or related disciplinewith a minimum of6+ years of analytical method development and qualification experience in pharmaceutical or biotechnology setting, with high preference inELISA binding assay,enzymatic assay, cell-based assay, andprocess-derived impuritymethods.

• Experience with method development, optimization, qualification, validation,transfer,and investigation for biotherapeutics

• Familiar withcGMP, ICH, USP and WHO guidelines on regulatory requirements for method qualification and validation

• Strong scientific skills in biochemistry,molecularand cellularbiology with good understanding of biological pathways and biotherapeutics mechanism of actions

• Ability to take initiative in problem solving and consistently bring independent, scientific approach to methoddevelopment.

• Excellent interpersonal skills and a strong ability to communicateeffectively.

• High levelofproficiencyin MS Office software including Word, Excel, Outlook, Visio, PowerPointJMPandSoftMaxPro

• The ability to independently contribute and oversee the generation of procedures,protocoland reportspertaining totestmethods.

• Ability to travel up to20% to support on-site training andtroubleshooting.

• The duties of this role aregenerally conductedin a 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/de-gown 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

Desired Skills:

• Experience in microbiology assays(e.g.bioburden, endotoxin,andsterility)

• Technical lead and/or people managing skills highlypreferred.

• Has knowledge of other technical areas within ADQC/PDCS organization (Other analytical methods such as LC, CE and compendial methods within ADQC; process development and formulation development within PDCS)

The annual base pay for this position ranges from $138,392 to $207,590. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Ready to make a difference? Apply now to join our team at Alexion!

Date Posted

Closing Date