Location: Indiana,PA, USA
Director, Continuous Improvement- Biologics Process Optimization Leader Position SummaryThe Director, Continuous Improvement – Process Optimization is responsible for developing and delivering process optimization across the Biologics network, which includes process simplification, complexity reduction, and introducing CI in development, clinical product, and processes. The role will have no direct reports and will work closely with the Site General Managers and Site CI Directors within the Biologics network.The focus of this Director, Continuous Improvement – Process Optimization will be identifying top pain points/complexity within processes and implementing network-wide solutions to simplify and standardize processes. This will include processes across the make, test, and ship within Biologics while also developing the playbook, tools & measurement systems for process optimization. This position will be identifying and implementing solutions that improve our ability to plan and execute the production of commercial and late-stage clinical products efficiently, timely, and with high quality. The scope of the role covers the entire product lifecycle including M&A, technology, and NPI assessments, but the primary focus of the role will be CI of commercial or clinical products. This Director will launch the COPQ (Cost of Poor Quality) program across the network while also establishing best practices in product transfers within the Product Development (PD) and Manufacturing Science & Technology (MS&T) functions using DFSS, QBD, APQP principles. The position will be highly collaborative and will require extensive leadership and influencing skills along with extensive change management expertise. As part of CI, the Director will develop, implement, and maintain a playbook with the Catalent Way team on how to simplify/standardize processes.The RoleDevelopment, management, and execution of process optimizationWork with multiple sites and teams to roll out the simplification, and complexity reduction with the network. Implement division-wide process re-engineering projects to achieve process improvements and simplification needed to satisfy evolving customer needsStandardize/re-engineer processes that can help build scale at a global levelIdentify and implement manual process improvement opportunities that can be automated to achieve process optimization, simplification, reduction in defects, enhanced employee experience and potential cost savingsExecuting process improvement analysis by conducting deep dives to identify gaps and map processes, conduct root cause analysis, formulate actionable recommendations, design solutions and trainings to quantify operational benefitsLaunch the Lean in NPI & proactive problem-solving process using APQP/QBD concepts and use tools like FMEA, DOE, SPC to help sites optimize products and processesSupport Quality & Continuous Improvement functional teams in building quality right the first time, waste elimination, and overall value creationLead Site project teams to deliver high-quality transformation projects. Establish and maintain relationships with key stakeholders to ensure implementation of the initiatives and ensure they are delivered on time and within budgetThe CandidateMinimum 12 years experience in Operations and Continuous Improvement roles in complex manufacturing environments. CDMO or Automotive industry expertise a plusBlack Belt, Master Black Belt or equivalent experience highly preferred8 years experience in leading a team of cross-functional professionals in a portfolio of projects5 years experience in process simplification and standardizationSubstantial hands-on experience with value stream mapping, QBD, APQP, COPQ reduction, etc.Demonstrated mastery of quality improvement methods such as LEAN, Six Sigma, Value stream mapping, etc requiredPreferred experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP)Extensive influential leadership experience; demonstrated change agent with substantial hands-on experience in technical and process problem-solvingStrong knowledge of cGMP and QbD regulations/guidance pertaining to the pharmaceutical industry preferredDemonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experiencePayThe anticipated salary range for this position in Maryland is $188,320 - $258,940 plus variable incentive compensation. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.Why You Should Join CatalentDefined career path and annual performance review and feedback processDiverse, inclusive culturePotential for career growth on an expanding team within an organization dedicated to preserving and bettering livesDynamic, fast-paced work environmentCommunity engagement and green initiativesGenerous 401k match and paid time off accrualMedical, dental, and vision benefits effective day one of employmentTuition reimbursementCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.#J-18808-Ljbffr