Development Scientist III, Analytical Development and Clinical Quality Control

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 AresidualDNA) in order to supportrelease and stability testing of biotherapeutic products and also formulation and process position also supports regulatory filing (IND and BLA) and responsesto inmethodstransfervalidationtroubleshooting and investigations ofbioassay andimpurity methods to internal and external laboratories may be addition this position is expected to interact regularly with other functional areas such as ResearchBiologic Drug Substance Development and InjectableDrug Product Developmentgroups as well as Manufacturing Quality Assurance and Quality Control groups.

Accountabilities:

• Developmentoptimizationand phase-appropriatequalificationofbioassays to evaluate quantitativebiologicalbiochemicaland cellularactivitiesfortherapeuticproteins.

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

• 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/ 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 assayenzymatic assay cell-based assay andprocess-derived impuritymethods.

• Experience with method development optimization qualification validationtransferand investigation for biotherapeutics

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

• Strong scientific skills in biochemistrymolecularand 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 proceduresprotocoland reportspertaining totestmethods.

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

• The duties of this role aregenerally conductedin a lab 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( endotoxinandsterility)

• 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)

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of four days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base pay for this position ranges from $138392 to $207590. 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 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.

At AstraZenecas Alexion division youll find an environment where innovation thrives. Our commitment to rare diseases means your work will have a profound impact on patients lives. With a rapidly expanding portfolio and an entrepreneurial spirit youll be part of a team that values connection and collaboration. We empower our employees through tailored development programs that align personal growth with our mission. Join us in driving change with integrity while celebrating diversity and innovation.

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

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.