Senior Scientist Formulation Development (m/f/x)

Job Introduction

Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra.

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 over 2500 colleague 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 Senior Scientist Formulation Development 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 Scientist Formulation Development 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 Scientist Formulation Development can be a 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.

Main Responsibilities

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in pharmaceutical research and development.
Independently designs, develops, optimizes and executes formulation laboratory experiments
Troubleshoots formulation issues that may occur during product development, validations, manufacturing processes, tech transfer/scale-up.
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. Processes must ensure quality, afford satisfactory yields and provide transferability to commercial manufacturing operations.
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.
Responsible for maintaining their training curriculum in line with departmental and company-wide SOPs and GMP regulations.
Measures 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.
Responsible for maintaining their training curriculum in line with departmental and company-wide SOPs and GMP regulations.
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 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.
Accurately and contemporaneously records experimental procedures, test results and observations, and reviews data to meet corporate, regulatory and GMP requirements.
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.
As applicable, arranges/performs purchase, qualification, calibration and maintenance for equipment or areas for which they are responsible.
Adheres to departmental and Dechra requirements for EH&S
Adheres to Dechra SOP and GMP requirements.
Reports project progress against technical and project objectives to Product Development, CMC (CMC leads) and Pharmaceutical Development Manager (functional line management).

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 keen to hear from those who have/are:

Bachelor’s or Master’s Degree in a relevant field e.g. Chemistry, Pharmaceutical Sciences
Experience in formulation development and/or manufacturing of a variety of dosage forms.
Good working knowledge of physical and chemical techniques used to characterise raw materials and finished products.
A proven track record e.g. ca. 3+ years’ experience in formulation development and/or manufacturing in a variety of pharmaceutical dosage forms.

Additional Details

Proven knowledge of regulatory requirements, including FDA, EMEA, VICH/ICH regulations
Demonstrated GMP (good manufacturing practice) proficient knowledge and experience in the pharmaceutical industry
Demonstrated project and technical leadership experience
Demonstrated success working in a cross-functional team environment on multiple concurrent projects
Demonstrated teamwork and interpersonal relationship management skills
Strong verbal and written communication in English

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 recruituk@dechra.com

The legal employer on behalf of Dechra in Croatia is Genera Inc.

Genera Inc. is a part of the Dechra Group since 2015

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