Director, Technical Operations
Our Work MattersAt Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.The Impact You Will MakeThe Director of Technology Operations is a strategic and technical leadership role responsible for providing cross-functional operational and technical support for sterile injectable manufacturing operations within a contract development and manufacturing organization (CDMO). This role serves as a key liaison between Operations, Quality, MSAT, Engineering, Validation, Supply Chain, and Client Services to ensure reliable commercial manufacturing support, rapid investigation resolution, successful technology transfers, and continuous process improvement.Reporting directly to Operations leadership, the Director of Technology Operations will lead technical operational initiatives supporting aseptic manufacturing, filling, visual inspection, packaging, and associated support systems while ensuring compliance with current GMP regulations and client expectations.Role Responsibilities Operational Technical SupportProvide technical leadership and operational support for commercial sterile injectable manufacturing operations.Serve as the primary technical escalation point for manufacturing issues impacting safety, quality, delivery, or cost.Partner closely with Manufacturing, Quality, and MSAT teams to ensure robust and compliant operations.Support daily production activities with rapid troubleshooting and risk-based decision-making.Drive operational excellence initiatives focused on throughput, efficiency, right-first-time performance, and deviation reduction.Investigations & CAPA ManagementLead and support complex manufacturing investigations, including deviations, OOS/OOT events, sterility assurance concerns, and equipment/process failures.Ensure investigations are scientifically sound, timely, and compliant with regulatory expectations.Facilitate root cause analysis using structured problem-solving methodologiesOversee development and implementation of effective CAPAs to prevent recurrence.Support inspection readiness and regulatory responses related to operational investigations.Commercial Manufacturing SupportProvide technical oversight for commercial product lifecycle support including:Process performance monitoringYield optimizationBatch record improvementsChange controlsCampaign managementCollaborate with Program Management to support customer communications and issue resolution.Support successful execution of manufacturing campaigns and schedule adherence.Technology Transfer & Process SupportSupport new product introductions, process transfers, and scale-up activities for sterile injectable products.Collaborate with MSAT and Validation teams on process qualification activities including:Media fills / APSPPQCleaning validationEquipment qualificationEnsure operational readiness for new technologies, products, and equipment implementationCross Functional LeadershipBuild strong partnerships across Operations, Quality, Engineering, Validation, and Supply Chain.Lead cross-functional technical review meetings and operational governance forums.Mentor technical operations staff and develop organizational technical capabilities.Promote a culture of accountability, compliance, continuous improvement, and teamwork.Continuous Improvement & Compliance Identify opportunities for operational optimization and implementation of Lean manufacturing principles.Support data-driven performance metrics and KPI development.Ensure compliance with:FDAEMAICHcGMPAnnex 1Data Integrity requirementsParticipate in internal audits, client audits, and regulatory inspectionsQualifications10+ years of experience in pharmaceutical manufacturing within sterile injectable and aseptic processing environments.5+ years of leadership experience in Operations, MSAT, Technical Services, or Manufacturing Support roles.Strong experience supporting commercial aseptic manufacturing operations in a CDMO/CMO environment preferred.Demonstrated expertise in:Aseptic processingSterile filling operationsContamination controlInvestigations and CAPAsTechnology transferGMP complianceStrong understanding of:Annex 1Aseptic processing simulation (APS/media fills)Environmental monitoringSterility assuranceProcess validationRoot cause investigationsRisk management principlesExperience with automated manufacturing systems and modern sterile manufacturing technologies preferred.Experience supporting isolator operations preferred.Experience with prefilled syringes, vials, or cartridges.Prior FDA, EMA, or client inspection support experience.California residents should review our Notice for California Employees and Applicants before applying.Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.Equal Opportunity EmployerKindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.Do you see yourself as part of the Kindeva mission? Click Apply Now Today!