MS&T Process Specialist

Job Introduction

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.

The Opportunity

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.

Role Responsibility

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	Engagement
Project Management	Problem Solving
Relationship Management	Customer Service
Results Focused	Technical Knowledge of Processes and Products

Person Specification

	Essential	Desirable
Behavior and Values Positive attitude Commitment Can do attitude Target driven Quality minded 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 multifunctional teams

Qualifications

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.

Skills

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.