At our Dartford site (CMT) our mission is to be the industry choice for high potent, high value API micronization. Today, we supply ~40 micronized product to a wide range of customers and patients. We’re committed to a culture of continuous improvement and people development so everyone at the site can grow and thrive.
Catalent is currently recruiting for a Technical Associate to join our Dartford site. This position is primarily responsible for supporting and managing cross-functional activities for assigned projects, typically for new product and existing commercial products and development projects. Dependent upon the level of support or management required, the position may be the main point of customer contact for project related activities and will involve managing the execution of the customer’s requirements as per an agreed upon programme of activities. The role will also provide technical support to ongoing commercial production activities.
The Role:
- Co-ordinate all project activities to ensure all projects are seen through to completion and are delivered in a timely manner to meet originally agreed timeframes.
- Collate and manage all new project documentation required for internal risk assessment review i.e. material questionnaires, methods, MSDS etc.
- Collating of new project technical information and requirements with the BDM’s and clients though kick-off and regular project meetings prior to production.
- Generation of statement of works and project instructions for existing and new projects to ensure all client requirements are captured.
- Liaise with other departments to ensure pre-campaign cross-functional activities are completed ahead of the scheduled manufacturing date as well as Liaising with Operations on the progress of the micronisation projects in production that require frequent feedback to clients.
- Ensure project activities comply with established documented procedures.
- Where designated, be primary point of customer contact on all project related issues and communication; ensure appropriate and timely communication is maintained. Lead and build cross-functional project teams comprising of representatives from relevant functions; chair internal and customer project teams.
- Assist in the control and monitoring of the project progress to ensure that milestones are accomplished on time and escalated as needed.
- Tracks milestones and budget associated to milestones for revenue recognition.
- Review project delivery (e.g. AAR) to seek out improvement opportunities and learnings from projects.
- Manage end-to-end delivery of all project and technical aspects of new product introduction via the NPI roadmap and procedure.
- Writing of validation protocols and reports.
- Actively manage the validation of processes.
- Provide technical support to production.
- Evaluate, highlight, and escalate unresolved issues, potential barriers to project progression, and resources constraints to supervisor and/or key stakeholders.
- Discuss any changes in the customer quoted programme of activities with internal team members and business development; communicate to the customer and ensure that the changes are fully documented.
The Candidate:
- Pharmaceutical GMP working environment (essential)
- Experience in managing projects from start to finish.
- Technical understanding of Pharmaceutical processes and documentation skills.
- Ability to communicate complex issues in a concise, coherent, and professional manner as well as negotiate difficult issues in a well thought out and professional manner.
- Educated to degree level or equivalent technical experience.
- Knowledge of Micronisation process (Highly advantageous)
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.
