Director – Process Design and Optimisation in Chemical Development

Job Title: Director Process Design and Optimisation in Chemical Development

Location: Macclesfield UK

Hybrid working model 3-5days per week onsite

About us:

At AstraZenecawereunited by a bold ambition: to push the boundaries of science and deliver life-changing medicines to patients worldwide. As a global science-led biopharmaceutical companywith an exciting androbustportfolioofnearly 200investigational therapiesat varied stages of clinical development(including>20atlate-stage)we transform pioneering research into breakthrough treatments across oncology cardiovascular respiratory and rare diseases. Here your talent will contribute to innovations that truly matterhelping us reimagine healthcare and create a healthier future for all!

Introduction to role:

We areseekinga highly skilled and motivated leader to join the Chemistry functionwithin AstraZenecas Chemical Development department asDirector Process Design and Optimisation

Are you ready to apply yourextensiveleadershipskillsanddrug developmentexperiencetoguide andinspireourchemists inprocess design and optimisationturningbold science into reliable medicines for patientsAsDirector (senior team manager)you willset the technical direction formodernprocess design and optimisationwhilstleadingyourteamto deliverhigh quality robustsustainablecommercial processesmanufacturing campaigns controlstrategiesand future-proofed regulatorysubmissions. Throughexploitinginnovative sciencecutting edgetechnologies andAI /data-driven solutions you willempower your team toreduce riskandshorten timelinesenablingconfident clinical supply and launch

Accountabilities:

Through leadinga process design and optimisation team in Chemistryyou willdrive

Technical excellence in project delivery:

• Applyingyour experience to successfulaccountability fordrug projectsatbothChemistry SectionandChemical Development functional levels

• Acting as a source of expert guidance fordevelopment of chemical processestechnologytransferand clinical drug substance manufactureboth internally and externally. You willfacilitateon-time right qualityclinicalAPIsuppliesandstrong data packages designedto seamlesslysupportonwardprocesscharacterisation and finalisation

• Delivery of CMC regulatory submissions for clinical and marketingphasesguiding and supportingauthorship ofdrug substance submissionsanddevelopingharmonisedcontrol strategiesat thesubstance-productinterface. Acting as anexperiencedrevieweryou will reducerisk and seekopportunitiesto drivethe bestoutcome for the business viaexcellence inauthorshipandresponse to regulatory questions

Seniorline-management ofaChemistrytechnicalteam including:

• Sophisticated coaching and mentoring to support professional developmentof8-10highly skilled scientists andscientificleadersup to and including Principal Scientist level

• Advanced performance management goal setting and regular feed-forward to drive high impact contributions at all levelsgeneratingimpactful meaningful career pathways foreach member of your team

• Mentorship coaching andonboarding of first-time team leadersandsupport and guidance forour wider chemistry team manager community

• Drivingkey elements ofSHEandcGxPcompliance forourChemistrysection

Contributing to key elements ofourChemistryStrategy including:

• Identification and execution of improvement programmes to enhance the capability and capacity of the Chemistry function to deliver their contribution to drug substance projectsthrough strong career pathways for our people

• Working across the section tospecificallychampionintegration of innovative route design and process design with associated support formodern business processes includingscale-up assessment and control strategy development. Employingcutting edgeAI / data techniques whereappropriate you will drive efficiency across the process design and optimisation areafor the business

• Understanding the external scienceand technology landscape to champion innovation and curiosity withinprocess design and optimisationyou will workacross interfaces toimprovestandards and ways of workingwhichimpactacross the whole projectlifecycle
  

Essential Skills/Experience:

• Degree PhDor equivalent experience in Chemistry plusanadditional8years experience in synthetic drug substance pharmaceutical development

• Proven high-impact people leadership experience witha trackrecordof delivery atAssociate Director(Team Manager)level; effectivelymanagingcoachingand developing scientific teamsto deliver complexprojects

• Expertisein development and scale-up of synthetic chemistry to deliver commerciallyviablemanufacturing processesin mid-to-late phase development including advancedunderstanding ofprocess designand optimisation.Proven experience incollaboration withinterface groupssuch asanalytical chemistry chemical engineering particlescienceand drug productin order toachieve your goals

• Strong understandingand experience of deliveryacrossthe drug development process especially late-stage development to support Phase 3 clinical studies and launchincluding control strategy development

• Strong project management skills developed through personal leadership and delivery of drug projects as well as thecapability to support multiple projects simultaneously within the team

• ProvenCMC-wideexperienceand an appreciation of how to generatethe best impact for patients.Demonstrated application ofthis experience tohigh qualityregulatory delivery throughauthoring and reviewing module 3.2 regulatory submissionsand/or response to health authority questions

• Demonstrated experience of managing change through continuous improvement increasing efficiency and with measurable impact inside and outsideofaChemical Development setting

• Track recordof driving the introduction of digital approaches and new synthetic / manufacturing platforms or technologies and examples of publicising these achievements to the outside world

• Extensiveexperience of leading seniorscientificstaff/ peersto deliverhigh impact improvements to ways of workingas well as projects in both an internal and external development and manufacturing setting

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 challengeperceptions.Thatswhy we work on average a minimum of three days per week from the office. But thatdoesntmeanwerenot flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!

***Please note: we operate a rolling recruitment process and may close this vacancy early if a strong candidate is identified. Early applications are strongly encouraged.

Competitive salary and benefits package on offer.

The successful candidate will have access to a flexible employee benefits fund including holiday purchase and flexible time off pension contributions Share Save Plans a performance recognition scheme and a competitive generous remuneration package

Why AstraZeneca:

Here your leadership turns complex science into dependable supply for patients worldwide. You will work with pioneering chemistry digital technologies and lean principles side by side with colleagues who put unexpected teams in the same room to crack tough problems. With a truly global network and strong investment in people and modern facilities you will grow your impact and your careerlearning from diverse teams shaping standards across sites and contributing to a more sustainable future. We value kindness alongside ambition andweback decisive leaders who take ownership and deliver outcomes that matter.

Call to Action:

Step forward to lead the chemistry that scales breakthrough molecules into life-changing medicinesand shapewhatsnext!