Dechra is an international specialist veterinary pharmaceuticals and related products business. Our expertise is in the development, manufacture and sales and marketing of high quality products exclusively for veterinarians worldwide.
We have offices across 24 countries in Europe and North America, we export to over 50 countries worldwide and have six manufacturing sites. The Dechra Group employ over one thousand people.
Our six Dechra Values: Dedication, Enjoyment, Courage, Honesty, Relationships and Ambition reflect the best aspects of behaviour and competence in Dechra. We embrace the values at every level of the business and everything about the business is underpinned by our values. How we talk to the people that matter, the way we always look to do things better and how we think of the people and the animals beyond the product.
We are active in Companion Animal, Equine and Food Producing Animal products and support our clients in practice with a wide range of materials and technical advice.
Genera is a company with more than a hundred years of tradition in manufacturing animal health products. Since 2015 it is a part of the Dechra Group.
For our Product Development team in Zagreb we are looking for a:
Senior Development Chemist (Formulation) (m/ž)
The Senior Development Chemist significantly contributes to the successful & timely development of novel and generic pharmaceutical products, utilizing formulation technologies/methodologies to carry out required development activities. The Senior Development Chemist must be able to work independently across the scope of development activities i.e. from bench top development through to supporting regulatory requirements for successful submission and approval of filings. The Senior Development Chemist is member of international cross-functional and cross-site project teams and participates in design and execution of Dechra development projects. In addition, a key aspect of this role is the technical leadership, coaching and co-ordination of colleagues to help achieve their respective project and development goals.
Plans, develops, executes and implements scientifically well-designed experimental programs and demonstrates creativity and capability in pharmaceutical research and development.
Development and scale up of robust drug product formulations and manufacturing processes based upon quality by design (QBD) concepts that address critical quality attributes and process parameters.
Applies key API and/or formulation physicochemical data to support the development process and to identify the root cause of potential stability, manufacturing and performance issues e.g. pKa, pH, solubility, disintegration, dissolution, particle size, HPLC assay, related substances etc.
Actively manages priorities and schedules experimental work etc. to meet or exceed project milestones. Regularly communicates project progress, challenges and potential delays to stakeholders.
Manages relationships and output of internal and/or contract labs that may be carrying out various development activities on company’s behalf.
Provide technical guidance in formulation development and associated analytical activities to less experienced colleagues.
Assists in the preparation of Chemistry, Manufacturing and Control (CMC) documents for Regulatory submission.
Independently authors and reviews technical documents, such as protocols, technical reports, batch records, test methods, and operating procedures.
Actively managing 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.
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.
Arranges/performs Preventative Maintenance (PM) and Performance Qualification (PQ) for equipment for which they are responsible.
Adheres to departmental and Dechra requirements for EH&S
Minimum 5 years of pharmaceutical development experience in formulation development or manufacturing in a variety of pharmaceutical dosage forms
Self-motivated, problem-solving, and analytical skills; able to manage priorities and workflow
Versatility, flexibility, and a creativity in resolving problems
Demonstrated success working in a cross-functional team environment on multiple projects
Strong verbal and written communication in English
Open ended contract
Interesting and challenging work in a dynamic team and international environment
Opportunity for professional growth and career development in a fast growing international pharmaceuticals company
To apply, please send us your CV and Cover letter in English via application link.