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Job Title

Associate Director, Manufacturing Operations

Requisition

JR000015470 Associate Director, Manufacturing Operations (Open)

Location

Horsham, PA

Additional Locations

Job Description Summary

Job Description

The Associate Director, Manufacturing Operations will provide leadership and management of operations at the Horsham, PA site, including but not limited to the following functional areas: Bulk drug substance manufacturing including Upstream Processing, Downstream Processing, and Manufacturing Support. The Associate Director is a member of the site leadership team and works collaboratively with senior site and company leadership to ensure production, cost, and compliance objectives are achieved.

ResponsibilitiesManufacturing and SupplyResponsible for all cGMP manufacturing at a site.Responsible for operational activities including packaging, buffer and media preparation, fermentation & purification operations, and oversight of warehouse management. Supports execution of the site production plan - accessible and ready to engage directly when critical issues arise or when leadership presence is needed to support the team. Routinely oversees production activities inside the manufacturing facility.Leads the development and execution of the site production plan in support of commercial and clinical manufacturing commitments provided via the master production plan; achieves a high degree of schedule adherence and proactively communicates schedule changes to site leadership team and key stakeholders.Organizational Performance & DevelopmentProvides clear direction and motivation to direct reports and other staff to achieve short- and long-term objectives.Develops and maintains strong working relationships within the site and external to the site; leads efforts to work collaboratively across the entire corporation to meet objectives.Develops and coaches direct reports and other staff to maximize personal growth opportunities; develops programs for employee engagement, development and training.Promotes and drives a right first time culture focused on mistake proofing and continuous improvement; leads organizational change initiatives focused on continuous improvement.QualificationsEducation & ExperienceMinimum BS in Chemical Engineering, Biology or life science, advanced degree (MS) preferred, or equivalent relevant experience.10-12+ years’ relevant experience in the pharmaceutical industry, with at least 5 years’ experience in a leadership role; commercial biologics manufacturing experience preferred.Proven ability to lead teams, drive change, and lead strategic initiatives. Demonstrated ability to successfully interact with regulatory agencies and direct experience with site regulatory inspections.KnowledgeStrong knowledge of biologics manufacturing technologies & processes including upstream and downstream operations, technology transfer, scale-up, testing, and validation requirements.Knowledge of cGMP, FDA, DEA and related international regulations.Quality systems, batch documentation, and inspection readinessTechnology transfer, including CMC documentation and scale-up proceduresSupply chain operations, vendor qualification, and logistics coordinationIndustry trends in automation, digital manufacturing, and predictive analyticsEmployee engagement strategies and training program developmentERP and manufacturing systems such as SAP or Oracle is plusFinancial/cost accounting experience managing multiple cost centers and budgets.Skills & AbilitiesAbility to align operational activities with strategic goalsProficient in planning and managing production schedulesStrong troubleshooting technical issues and optimizing manufacturing processesExperienced in leading cross-functional initiatives and technology transfersCapable of developing budgets and implementing cost control strategiesAdept at coaching and developing staff to enhance performance and engagementDrives change initiatives and fosters a culture of continuous improvementCollaborates effectively across departments and teamsTeam player with a strong customer orientation and ability to manage complex operations in a dynamic, team based environment.Analytical, data-driven decision maker with the ability to quickly get to the fundamental root cause of problems and issues in order to implement solutions and/or facilitate rapid resolution.Strong negotiation, written communication, and public presentation skills.Physical RequirementsPrimarily operates in a professional office setting with regular visits to manufacturing areas, which include cleanrooms and controlled environments. Ability to wear a sterile gown and don shoe covers as neededTechnical SupportProvides technical expertise and manufacturing support for trouble shooting of manufacturing processes, investigations, process improvements, and supplier and material qualification.May partner with R&D to support clinical supply requirements and to develop and implement new manufacturing processes to support pipeline products.Identifies and implements continuous improvement projects to improve cost and compliance within manufacturing operations.Quality & ComplianceProvides leadership and supports the organization’s quality and compliance objectives, ensuring the facilities are in a constant state of inspection readiness and compliant with regulatory agency requirements.Ensures staff initiates and maintains appropriate training required to perform required job responsibilities and manufacturing activities are performed according to cGMP standards and all applicable Regulatory requirements.Creates and maintains batch documentation, operational procedures, and records to support site operations.Participates in Regulatory inspections/audits as the manufacturing site lead.Conducts manufacturing operations in accordance with applicable EH&S regulations ensuring team members operate with a focus safety and compliance.FinancialRecommends annual expense and capital budgets for approval.Manages annual spending and production costs according to approved plans.Identifies and implements cost improvement opportunities to drive manufacturing efficiency.

At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop.

Invest in your own career with Mallinckrodt and let’s do something dynamic together.

Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.

Additional information on Mallinckrodt’s hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)