Technical Services Manager
The Technical Services Manager reports directly to The Director of Technical Services.
Reporting to the Director of Technical Services, the Technical Services Manager will provide technical direction and expertise in order to commercialize new products and technologies and to optimize commercial manufacturing processes. 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 Technical Services Manager will have a working knowledge of various aspects of implementing the drug development process in a regulated environment, including topics such as Quality by Design (QbD), Design of Experiment (DOE), and compliance with all regulatory guidelines
Duties and Responsibilities
- In collaboration with R&D, QA and Operations plan, coordinate, and drive the scale up, optimization and commercialization of products and technologies by working with staff and Project Management, within the Catalent Project Management framework, to ensure timelines are met; road blocks are identified early; and resources are coordinated
- Work with R&D, QA and Operations to perform evaluation and risk assessment of project/program data in order to: implement products and technologies into commercial production; 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
- Provide technical leadership and mentoring to individuals, functional area and overall organization
- Manage resources and ensure appropriate technical review and oversight for portfolio projects/programs
- Effectively communicate on a timely basis with management and other departments within Catalent and customers to ensure clear understanding and acknowledgment of project/program status, risks, actions, and outcomes
- Manage staff on projects to ensure resource requirements are met, and constraints identified
- Mentor, train and coach staff in establishing effective studies with appropriate risk management
- Keep updated on regulatory guidelines to ensure programs are current
- Maintain and update process validation program and technical transfer program as necessary
- Review and approve process validation protocols, process validation reports and study protocols, as appropriate
- Prepare and execute process validation protocols, process validation reports and study protocols, as appropriate
- Perform risk assessments to develop approaches to technical transfer for products and technologies
- Prepare and update technical transfer plans for products and technologies
- Operate under and maintain GMP conditions
- Represent functional area and projects at local, technical, governance, executive and customer meetings
- Communicate and ensure staff awareness and understanding of Catalent strategy, initiatives, expectations, processes, and portfolio status
- Supervise, train and evaluate direct reports according to company guidelines
- Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met
- Perform other duties as required.
- Bachelor’s Degree in Engineering (Chem., Indus., Mech., Elec.), life science (Chemistry, Biochemistry, Biology) or related field.
- Minimum 5-7 years of experience in production process introductions / improvements at a project manager level.
- Experience working in a manufacturing, pharmaceutical and/or GMP facility.
- In depth knowledge of soft gel manufacturing and encapsulation processes
- Demonstrated ability to resolve production issues, lead and complete projects within scope, schedule and budget to deliver the anticipated benefits
- Excellent project leadership, decision-making, problem solving, facilitation and interpersonal skills
- Ability to influence stakeholders, build trust and respect within the overall organization
- Resourceful, innovative and persuasive
While performing the responsibilities of the job, these work environment characteristics are representative of the environment the employee will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.
The noise level in the work environment is usually quiet to moderate.
Position located in Windsor, Ontario or Strathroy, Ontario.
Regular working hours: 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute unpaid lunch.
These physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential duties of the job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of the job.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard. Use of manual dexterity is required. The employee is occasionally required 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.
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.