Catalent is a global, high growth, public company and leading partner for the pharmaceutical industry in the development and manufacturing of the new treatments for patients worldwide. Your talents, ideas, and passion is essential to our mission: to help people live better, healthier lives.

Our Bathgate facility has an opening for a Manager of Technical Services to join their team.  As the Manager of Technical Services, you will focus on instituting alignment across Pre-Production Operations functions inclusive of study set up, Packaging Engineering and Batch Record Creation.  The primary responsibility is to ensure on-time and right first-time execution of the technical documentation for on-time clinical packaging activities.

The Role

Build, maintain and motivate a team capable of efficiently setting up Client studies to ensure effective operational execution meeting the Client needs for study design in scope to the contract.

Build a team who can manage achieving all documentation and technical targets and training requirements to service customers on time and right first time.

Manage work allocation, planning of all tasks proactively, managing the plan, making independent leadership decisions to mitigate risks daily to ensure successful delivery

Resource Plan, using data, and S&OP data to ensure resource requirements are met, and constraints identified

Mentor, train and coach staff in establishing effective studies with appropriate risk management

Work directly with Quality Assurance, Engineering, and Project Management functional areas to plan and implement documentation and training requirements for GMP (Good Manufacturing Practice) activities in manufacturing for clinical packaging operations.

Responsible for overseeing all site investigation/deviation tracking and overall timings per defined site process.

Lead and manage the closure of all Corrections/Tasks and other Track Wise system reports for timely resolution and closure. With minimal supervision, lead the creation of SOP’s, Batch Records, other Technical Specifications and Training procedures to drive effective operations.

Lead the review of SOPs, cGMP documentation, Batch Records, product related technical information, protocols, to ensure compliance with regulatory agencies and Company procedures.

Provide direct support for customer/regulatory audits and responses to those audits.

Candidate Requirements

A Strong back ground in Quality and clinical supply management

Proven track record of driving results and change management with excellent communication skills

Pharmaceutical packaging and manufacturing experience preferred

ERP systems expertise preferred including JDEdwards, Fusion, Clinicopia, and other platforms

Demonstrated ability to supervise professional, technical associates, peers and non-direct reporting staff

Excellent interpersonal and communication skills

Computer literate (proficient in Microsoft Office Suite products)

Knowledge of cGMPs, and all applicable country, state, and local rules and regulations

Leadership and team building skills

Position Benefits

Annual Salary

Pension

Life Assurance

Bupa Healthcare

Opportunities to join Employee Resource groups and be involved in charity events

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. 

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.