Job Description:

Director of Sterile Injectable Manufacturing - Pharmaceutical IndustryCOMPANYOver 30 years in business this Nationally recognized CDMO is focused on small molecule product development projects from discovery to commercialization for it's pharmaceutical partners.OVERVIEW OF ROLEThe Director of Manufacturing Injectables serves as the functional head of operations, providing oversight of clinical & commercial production activities. This position is a key member of the site leadership team, working to execute long-term strategies and revenue achievement.KEY EXPERIENCE AND ATTITUDE REQUIRED TO WIN IN THIS ROLEThe right candidate should possess a boots on the ground mentality with an eagerness to connect with operators and technicians with a focus on giving them the tools to succeed.The right candidate should possess a strong track record of change management and process improvement with tools they have implemented in the past which drove accountability at all levels of the pharmaceutical manufacturing process.RESPONSIBILITIESImplement systems, tools, and resources to ensure successful achievement of revenue related targetsOversight of operational aspects of manufacturing, including: productivity, cost, planning, daily business processes, cGMP compliance, and safetyKey contributor to positive client relationships by ensuring adherence to customer requirementsspecifications, open communication, and resolution of any issuesEnsure execution of on-boarding activities and training plansCollaborate effectively with Master Scheduler to establish demand plan and detailed schedule, articulate key financial milestones for forecastDrive manufacturing technology, automation, and facility strategies through partnership with EngineeringLead, coach, and provide direction to direct reports, as well as indirect reporting relationshipsManagement and oversight of departmental budget(s)Collaborate with Project Management team to ensure that operations' resources are effectively deployed and meet client expectationsCollaborate with QualityValidation to support the validation lifecycle of all equipment, utilities, facilities, systems and processesEstablish and track the relevant KPIs to improve the efficiency and quality of the GMP manufacturing operationsPartner with Business Development, Project Management, R&D, and Quality Leadership teams to ensure compliance within the quality systemQUALIFICATIONSBachelor's degree or higher in Engineering, Pharmaceutical Science, or a related fieldMinimum of 10 years of experience in aseptic manufacturing, preferably in the pharmaceutical or biotech industryStrong knowledge and understanding of cGMP, FDA regulations, and aseptic processing principles, technologies, and equipmentDemonstrated experience in leading teams, project management, problem solving, and developing and executing operational and capital budgetsExcellent communication, interpersonal, and leadership skills, and ability to work effectively in a cross-functional and dynamic environmentExperience with process validation, contamination control, quality systems, and continuous improvement methodologies (e.g., Six Sigma, Lean, Kaizen, etc.)BENEFITSCompetitive salary and annual bonus.Relocation assistance.Medical, Dental, Vision and Life Insurance and Disability Insurance.401k