Development Chemist (Formulation) Skipton, England
Job description
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC.
Dechra are 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
Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise lies in the development, manufacture, sales and marketing of high-quality products exclusively for veterinarians worldwide.
The Development Chemist Formulation role contributes to the successful and timely development of novel and generic pharmaceutical products, via the development, preparation and selection of appropriate and physically/chemically stable formulations for a variety of dosage forms. The Development Chemist must be able to work independently in the conduct of bench top research and development programmes, is responsible for drug product formulation development and preparation of new formulations in support of (pre)clinical studies and stability studies, the design of the manufacturing process and support the scale of up for manufacturing of registration and process validation batches and contributing to the successful submission and approval of worldwide regulatory filings, The Development Chemist participates in execution of Dechra development projects and can participate in international cross-functional and cross-site project teams. Solid dosage forms (tablets and capsules) are the primary products developed and evaluated by the Skipton team.
Main ResponsibilitiesSo, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
Development and characterisation of appropriate formulations (and their constituents) and selection of packages to meet marketing, clinical and regulatory requirements
Manufacture small (laboratory) scale formulation batches using processes that are appropriate for manufacturing on a commercial scale, for use in characterization, non-clinical and clinical testing (such as direct compression, wet granulation, fluid bed drying/granulation, tablet coating).
Involved in formulation development and manufacturing process development from pre-formulation to technology transfer to manufacturing site.
Expert in the handling of tablet manufacturing equipment, such as tablet press, roller compactor, blending equipment and equipment to analyze the formulations. Keeping up to date with advances in formulation and manufacturing technology.
Applies key API and/or formulation physicochemical data to support development process and identiy the root cause of potential manufacturing, stability and performance issues (eg. pKa, pH, solubility, disintegration, dissolution, particle size, HPLC assay, etc.) actively manages priorities and schedules experimental work etc to meet or exceed project milestones in collaboration with analytical and other CMC colleagues. Regularly communicates project progress, challenges and potential delays to stakeholders.
Actively contributes to planning, developing and implementation of scientifically well-designed experimental programs and demonstrates creativity and capability in pharmaceutical research and development (with support from senior colleagues as required).
Adheres to departmental and Dechra EH&S requirements.
Adheres to Dechra SOP and GMP requirements.
Accurately and contemporaneously records experimental procedures, test results and observations and reviews data to meet corporate, regulatory and GMP requirements.
Actively manages priorities and schedules experimental work etc to meet or exceed project milestones in collaboration with analytical and other CMC colleagues. Regularly communicates project progress, challenges and potential delays to stakeholders.
Responsible for maintaining their training curriculum in line with departmental and company-wide SOPs and GMP regulations
As applicable, arranges/performs Preventative Maintenance (PM) and Performance Qualification (PQ) for equipment for which they are responsible.
Timely monitoring and evaluation of release and stability data for GMP compliance, out of specifications, out of trend, and method performance issues, conduct and co-ordinate investigations and recommend corrective and preventative actions as needed.
Authors and reviews technical documents, such as protocols, reports, batch records, and operating procedures.
Assists in preparation of Chemistry, Manufacturing and Control (CMC) documents for Regulatory submission.
Actively manages working relationships through engagement with cross-functional and cross-site teams in the design and execution of studies e.g. technical services/manufacturing, clinical, regulatory, QA/QC etc.
Reports project progress against technical and project objectives to Product Development Manager, CMC (CMC lead) and Pharmaceutical Development Manager (functional line management).
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly keen to hear from those who have/are:
- Bachelor’s or Master’s Degree in a relevant field e.g. Chemistry, Pharmaceutical Sciences, Pharmacy.
- Hands-on experience in formulation development of a variety of dosage forms, some past tablet experience is essential to role.
- Good working knowledge of physical and chemical techniques used to characterise raw materials and finished products.
- Working knowledge of regulatory requirements, including FDA, EMEA, VICH/ICH regulations.
- Self motivated driven and resourceful
- Demonstrated ability in planning and priority setting
- Ability to work effectively as a member of a team
- Highly organised
All applications received are reviewed by our internal talent acquisition team and we will get in touch if your skills and experience match what we’re looking for. Should you not hear back from us within 28 days please don’t be too disappointed – we may keep your CV on our database for any future vacancies which may be suitable and we encourage you to keep an eye on our careers site. For any questions or queries, please contact us at [email protected]
