Manufacturing Science and Technology Manager

Position Summary  
The Manufacturing Science and Technology Leader will provide technical direction and expertise to optimize commercial manufacturing processes and commercialize new products and technologies.   
 
This will include activities such as process scale-up (pertaining to both products and technologies), technical transfers, commercialization, and ongoing product/process stewardship. This will be accomplished by focusing on product / process robustness, quality, customer service and cost performance. The Manufacturing Science & Technology Leader will provide reviews of earlier development work to ensure a streamlined transition to commercialization efforts which can include additional studies or treatments in later development stages.  

Regular working hours: 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute lunch. 

The Role 

• In collaboration with R&D, Operations, Quality and Engineering, plan, coordinate, and drive scale up, optimization and commercialization of products 

• Develop new technologies to meet product and process requirements 

• Work with multiple departments and operating withing the Catalent Project Management framework to ensure timelines are met, roadblocks are identified early, and resources are coordinated 

• Perform evaluation and risk assessment of project/program data to establish process improvements based on trend analysis and study data; investigate issues and customer complaints, and determine corrective actions and ensure commercial product manufacturing processes are robust  

• Overall responsibility for the Strategy, Execution and Regulatory Compliance of all Validation activities and programs for the site; including but not limited to manufacturing and packaging process validation; equipment, utility, and facility qualification; cleaning validation; computer system validation; appropriate validation master plan development and update 

• Facilitate the Technology Transfer process by utilizing the documentation of data covering all aspects of development, production, and quality control 

• Responsible for the Technology Transfer process between Catalent facilities, facilitate comprehensive technical gap analysis, ensuring product-specific requirements are met, facilitating the implementation process, and ensuring all required documentation is completed 

• Perform other duties as required 

The Candidate 

• Bachelor’s Degree in Life Sciences, Engineering, or related field 

• Master’s Degree preferred 

• Minimum 5 years of experience in production process introductions / improvements at a project manager level, within a manufacturing, food, pharmaceutical environment. 

• GMP facility experience an asset 

• Significant Technical or managerial experience with established food / pharmaceutical manufacturer or contract manufacturing organization 

• Ability to prioritize, and lead others to achieve results 

• Demonstrated ability to resolve production issues, lead and complete projects within scope, schedule, and budget, following PMO processes to deliver the anticipated benefits 

• Excellent project leadership, decision-making, problem solving, facilitation and interpersonal skills 

• Ability to sit and use hands and fingers, to handle or feel and to manipulate keys on a keyboard  

• Use of manual dexterity is required 

• Ability to stand, walk, reach with arms and hands, bend, or twist, and to stoop, kneel, crouch or crawl 

• Vision abilities required by this job include close vision 

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 including 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 to explore career opportunities.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

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.