MS&T Process Specialist
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC.
Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.
MS&T Process Specialist involves in providing technical support for cGMP activities such as tech transfer, process engineering, process validation, process monitoring, and computer system validation (CSV) in the cGMP manufacturing facility. They often participate on supporting and troubleshooting manufacturing challenges, develop effective ways to monitor product performance, and analyze data.
His/her goal is to achieve high quality products on a consistent basis. Create instructions documents such as protocol and reports documents for development and process validation batches. They analyze the results of testing and determine their acceptability against predetermined criteria. They require adherence to strict documentation, reviews, and approvals. MS&T Process Specialist also investigates and troubleshoot problems and determine solutions or recommendations for changes and improvements.
So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:
The MS&T Process Specialist functions includes but are not limited to:
- Author and execute validation protocols for transfer and new pharmaceutical products.
- Responsible for developing and enhancing manufacturing processes for topical and oral pharmaceutical products.
- Generate and maintain documents related to GMP Manufacturing executions, product impact assessments.
- Drives the strategy and daily operations of the MS&T arm of the Continuous Manufacturing Process team.
- Responsible for the ongoing process monitoring of currently marketed products.
- Author change control and SOPs associated with batch records and validation of existing and/or new products as well as new and/or existing processes.
- Investigate and resolve manufacturing issues of pharmaceutical products.
- Perform small scale formulation studies of topical and oral products
- Supports management of the Site Master Validation Program (SMVP).
- Support in new cost reduction strategies and activities.
- Define and provide user requirements for process equipment associated drug product manufacturing.
- Work within or lead cross-functional teams in a positive fashion to implement manufacturing objectives.
- Prepare/review technical documents including supporting batch records, formulation/solution/batch records, item specifications, project reports, and engineering specifications.
- Help develop and maintain performance metrics, reporting and data analysis tasks to identify issues and opportunities.
- Performs other duties as assigned.
- Familiarity with ERP and chromatographic system is a plus
- Support technical and quality related projects
- Support Validations scheduled as planned competencies
- Key Performance Indicators
The Ideal Candidate
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly excited to hear from those who have/are:
Commercial and Business Acumen
Technical Knowledge of Processes and Products
Behavior and Values
Can do attitude
Work under pressure
(D) Committed to delivering excellence
(E) Enthusiastic and results driven
(C) Able to take calculated risks
(H) Honesty and integrity
(R) Team player
(A) Willing and able to go the extra mile
Previous R&D experience
Able to work with
- Bachelor’s degree in Chemistry, Engineering, Statistics, or related discipline required
Knowledge and Experience
- A minimum of 4 years of relevant experience in pharmaceutical formulation and manufacturing required.
- Experience in authoring and executing validation protocols including cleaning and process development
- Experience in authoring reports, SOPs and MBRs
- Hands on experience in formulation of liquid and solid dosage form
- Experience in scale up activities of topical and oral pharmaceutical products.
- Experience in cGMP documentation practices and statistical tools
- Extensive experience in GMP manufacturing and compliance with demonstrated knowledge and experience related product development of pharmaceutical manufacturing
- Previous experience of time management and project management
- Experience in product launch and formulations.
- Demonstrates a “can do” approach
- Must have Excellent interpersonal and communication skills (written and verbal) across a wide range of disciplines, especially the ability to communicate diplomatically and work effectively in a multi-disciplinary team
- Ability to multi-task, set priorities and meet strict deadlines
- Demonstrates time management skills
- Using logic and reasoning to identify solutions to problems
- Ability to lead, motivate, coach, and teach others
- Ability to prioritize, demonstrating good time management skills
About the Company
As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an employee stock purchase plan for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.
Dechra Pharmaceuticals PLC