Catalent Pharma Solutions

Job Title: Sr. Director, Technical Services

Location: Bloomington, IN

Position Summary:

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients.  The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team.  Catalent Biologics is making significant investments in people and capabilities.  This is a unique opening to join a small, fast-growing business, backed by a global public company.  People joining our team will have the opportunity for career development as our business continues to grow and expand.  Catalent employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer’s.

The Role

• The Technical Services function encompasses Engineering, MS&T, Validation, and Continuous Improvement.

• Engineering is responsible for supporting CGMP operations through process engineering, facilities and utilities engineering, calibration, process improvement and automation, packaging, capital projects, while maintaining compliance with regulatory standards.

• Process Engineering has oversight of consumable and raw material lifecycle management inclusive of process function definition, design through drawing approval, onboarding support, and change management. This function ensures integration of consumables with equipment and associated manufacturing processes, while maintaining larger strategy project ownership across the facility (e.g., equipment methods, risk assessments, control strategies, etc.).

• Equipment Engineering group has oversight of equipment lifecycle management inclusive of equipment design (URS through qualification support and release), equipment updates (design modifications via change management), and general equipment support through troubleshooting, training, and continuous improvement. This function also maintains ownership of the capital expenditure (CapEx) process.                    

• MS&T is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

• Continuous Improvement teams are responsible for leading continuous improvement and operational excellence throughout the organization by identifying, planning, facilitating, and implementing projects for sustainable improvements. The Continuous Improvement team is an effective change-agent who collaborate continuously with front-line personnel and spends extensive time in the areas of improvement.

• The Technical Services Senior Director will receive assignments in the form of annual (site specific) objectives (projects) and develop goals to meet those project objectives. This individual may establish new SOPs and/or recommend changes to current SOPs based on facility needs. This person will work on complex problems requiring in depth analysis of data to determine appropriate action. Poor decisions could result in delay of business operations and lead to project delays, which could ultimately jeopardize site business activities. This person is expected to have extensive communication with employees and cross-functional group managers/departments on facility related issues.

• This role will direct on-call and on-the-floor technical support to manufacturing. The leader will be responsible for the drafting and review of documentation, compilation, and assessment of applicable data, change management, utilization, and monitoring while providing technical input. This position will be client facing and should possess the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward.

• This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

• Responsible for the development, implementation, and ownership of a comprehensive Engineering, Facility Maintenance, Technical Services, Manufacturing Technology, Validation, and Continuous Improvement.

• Take a proactive approach to shape and influence internal and external executive stakeholder expectations across the organization.

• Serve as a liaison between different sites and business units for strategic programs and cross functional alignment.

• Effectively align and influence the interests of multiple executive stakeholders (client programs and company) with different priorities to quickly drive decisions to complex conflicts with broad organizational impact.

• Help define department objectives to align with business unit goals. Regularly communicate to team, department, and company about department and company priorities. Monitor and evaluate social, fiscal, and political trends that affect the plan.

• Make implementation plans and assignments that allocate strategic and inter-site resources appropriately to complete objective and drive development opportunities.

• Prepare strategies to deal with anticipated problems or drastic changes for department and company initiatives and team's projects.

• Identify activities with relevant milestones and schedules to effectively manage the progress and performance of team and own work developing metrics to monitor performance to goal and establishing best practices with multiple site impact.

• Share own ideas in a compelling manner that gains commitment from organization.

• Inspire and persuade others to pursue and achieve goals.

• Negotiate skillfully and professionally and persuade others to approach complex organizational issues in the same manner.

• Win concessions while building relationships or knowing when to yield to another's point of view. Teach peers the art of persuasion.

• Anticipate reactions and positions of others and plan accordingly. Mentor peers to do the same.

• Lead team members to improve and reinforce performance of others.

• Take responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly.

• Work with, coach, and support direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development.

• Responsible for maintaining a high performing team by hiring, training, motivating, evaluating, and developing staff (direct reports and others).

• Contribute to the company’s overall probability and growth strategy.

• Performs additional duties as assigned.

Engineering Specific:

• Organize, manage, develop, and implement project plans, construction projects, designs, assembly of equipment, processes, and systems to ensure timely project completion in compliance with regulatory agency requirements, internal company standards, and current industry practices.

• Manage multi-use facility, including HVAC systems and bio-containment systems

• Responsible for acceptance and installation of manufacturing equipment

• Work with facility commissioning/validation team, including operational protocol development, to implement compliance with cGMP requirements.

• Draft Standard Operating Procedures (SOPs) for building operation, maintenance, and security

• Manage facility preventative maintenance and provide guidance and execution on facilities and equipment projects.

MS&T/Validation Specific:

• Apply technical, functional, business, and/or industry knowledge to design experiments or project scopes; provide scientific or business consultation to the site and executive leadership team and manage multiple functions and/or focuses across site disciplines.

• Actively define and execute on the strategic direction of the department by recommending expansion or curtailment of investigations on the basis of experimental results or scientific information.

• Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer and maintain processes in the facility.

• Lead and/or support the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.

• Evaluate existing processes and identify process or equipment improvements to advance efficiency, consistency, and competitiveness within the market.

• Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.

CI Specific:

• Oversees Continuous Improvement function including knowledge dissemination, cost effective practices, standardization, Elements of Six Sigma, best practices, knowledge creation, assessment, technical expertise, and knowledge management to develop sustained productivity improvement in the site and a superior site performance.

• Develop site Continuous Improvement plan by partnering with business leaders to meet their Strategic and Operational goals.

• Facilitate impactful improvements through Continuous improvement tools, Kaizen funnel process, and systems to improve key performance indicators.

• Identify performance gaps through data, best practices and prior lean deployment experience.

• Utilize a structured problem-solving approach to analyze current conditions, identify improvement opportunities, and deploy Lean and Six Sigma tools.

• Lead and coach Kaizen events through hands-on participation.

The Candidate

• Bachelor’s degree in science field, required.

• Master’s degree, preferred.

• 10+ years of relevant leadership experience

• GMP experience, required.

• Must be able to read and understand English-written job instructions and safety requirements.

• Experience in report and documentation skills.

• Experience with statistical techniques for data analysis and reporting.

• Direct personnel and organizational group management experience, including mentoring and training staff members cross-functionally.

• Experience in investigating and closing deviations, OOS, and CAPAs

• Experience drafting and revising standard operating procedures, batch production records, and reports.

• Experience with operating and troubleshooting process equipment, including single-use systems and consumables.

• Experience working on late phase, process performance qualification, and commercial programs is a plus.

Why you should join Catalent

• Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)

• Group Retirement Savings –Registered Pension Plan (RPP) with employer contributions.

• Paid Time Off Programs incl. vacation, banked time & personal time.

• Employee Reward & Recognition programs.

• Opportunities for professional and personal development & growth including tuition reimbursement.

Catalent 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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .