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POSITIONSUMMARY:
The Director, Drug SubstanceManufacturing oversees commercialandclinicalmanufacturingactivities and the technicalaspectsassociated withmanufacturing and productionprocesses atthird partymanufacturersand suppliers.TherolewillinteractwithexternalContract Development and Manufacturing Organizations (CDMOs),regulatoryagencies,andcorporate partners, as the company liaison for manufacturing support of commercial products and new product regulatory submissions.
ESSENTIALFUNCTIONSANDRESPONSIBILITIES:
Theseinclude,butare notlimited to:
Establishand maintainstrong capabilityfordrug substance manufacturingprocesses andimplementpolicies and procedurestooptimize internalresources,for monitoring manufacturing processes
Createefficientbusiness practicesfor leveraging externalCDMO activities and internal functional teamstodrivedrugsubstanceproductionactivities, including the review of protocols, reports, process data and executed batch records
Collaborate with Process Development todevelop and translate process knowledge and understanding into manufacturing controls strategy (product, process, materials, environment, etc.) to ensure successful process scale up and tech transfer, validation activities as well as resolve complex process/product issues
Support new product scale-up, production, process optimization, technology transfer, and process validation activities at CDMOs and change implementation to established commercial processes
Collaborate with CDMOs to drive investigations and troubleshooting activities to ensure project milestones are met and product is produced per forecast to meet demand
Drive implementation of process improvements and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance
Design, implement and maintain process control strategies utilizing statistical analysis tools (e.g. JMP) to identify, quantify and minimize process risks
Lead manufacturingteamsin allCMCaspects fornewproducts underdevelopment and maintenance of existing products,suchasdefining productionobjectives,resource planningandexecution,deliveryagainstgoals and projectmilestones
Leadlate stage developmentcontracts,commercialcontracts,and quality/technicalagreementnegotiations and assist in department budgets, vendor selection, and project oversight
Manage the career development and technical expertise of staff to ensure performance standards are met
ADDITIONALFUNCTIONSANDRESPONSIBILITIES:
Supportthe Director(s)ofProcess Development,AnalyticalDevelopment,SupplyChain,RegulatoryAffairs andQuality,as theprincipalmanufacturingexpertforCMC issues relatedtodrug substances andassistinauthoringsectionsofregulatorysubmissions;establish,justifyand defendmanufacturing processesandprovide technicalsupportfor ongoing QC andmanufacturing operations
Supporttechnologytransfer,scale-up andvalidationofGMPproductmanufacturing activities and provide supportforongoingmanufacturingactivities and investigations relatedtomanufacturing
Collaborate with Halozyme Partnerstoprovide andhelpoptimize efficientmanufacturing departmentalcontributions andaccountabilitytomatrixteamsand contributetoresource planningandallocationacross projects and programsinconcertwithProcess Development and Manufacturing
Otherduties as required
EDUCATION,EXPERIENCE,KNOWLEDGE, SKILLSANDABILITIESREQUIRED:
Minimum of BS degree in a life science with at least 10 years’ experience inmanufacturing operations,process development,technologytransfer, and/or process validation,etc. with abiotech,biopharmaceutical,orpharmaceuticalcompanyincludingdrug developmentresponsibilitiesfrompre-clinicalthroughPhase-IIIdevelopmentand registrationstages. (An equivalent combination of education and experience may be considered)
Experience with contract manufacturing partners while maintaining a positive working relationship as well as knowledge of cGMP’s, global regulatory guidelines, and other relevant regulatory requirements
Minimum 5years’experienceleadingagroupoftechnicalstaffwithatrackrecordoffosteringstaff developmentin acollaborative,supportivelearning environment
Knowledgeofregulatoryrequirementsforrecombinantproteinpharmaceuticalproducts is required
Advanced trouble shootingandproblem-solving skills
Strong technical expertise and experience with applying Quality by Design (QbD) concepts and statistical process design and analysis (JMP® statistical software)
Excellentcommunication,presentation,and technicalwritingskills
Ability to work in a fast-paced, innovative environment
TECHNICALKNOWLEDGEREQUIRED:
Equipment:PC,scanners,facsimilemachine,voicemailande-mailsystems,andcommonofficemachines,orabilitytobetrained.Knowledgeofotherequipmentrequired:familiaritywitha broadrangeofmanufacturingequipmentand processes.
SoftwareKnowledge:Windows,MSOffice(Outlook,Word,Excel).Knowledgeofothersoftware required: statisticalanalysis tools
INTERNALANDEXTERNALRELATIONSHIPS:
Supportother functionaldepartments/groupsparticularlythosecomprisingthe“CMC”discipline (i.e.ProcessDevelopment,Analytical Development,QualityControl,QualityAssurance,RegulatoryAffairs)
Supportandparticipateonprojectteams workingonthe developmentofHalozyme’sproprietaryproductsorpartneredprograms
Interactwith,support,and provide oversightofthird-partycontactmanufacturers andmaterialsuppliers
EFFORTREQUIRED/ENVIRONMENTALCONDITIONS:
PhysicalActivities:Onacontinuousbasis,sitatdesk for alongperiodoftime;intermittentlyanswertelephoneandwriteor use akeyboardtocommunicatethroughwritten means.Some walkingand liftingup to 20 lbs.mayberequired.Thenoiselevelintheworkenvironmentis usually low tomoderate.Thephysicaldemandsdescribedabovearerepresentativeofthosethatmustbemetbyanemployeetosuccessfullyperformtheessentialfunctionsandresponsibilitiesof this job.Reasonableaccommodationsmaybemadetoenableindividualswithdisabilitiestoperformtheessentialfunctionsandresponsibilities.
LaboratoryActivities,ifapplicable:Biologyandchemicallaboratoryenvironmentsexperience needed.Environmentalhealthandsafetyrequirementsalsoapply.
TRAVEL:
Travelmayberequiredup to 40% ofyour time
