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Pošalji prijatelju

Associate Formulator (m/f)

Zagreb

Rok prijave:

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.

The Dechra group employ over one thousand people worldwide. 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, food supplements in the form of vitamins and minerals, disinfectants use and plant protection products. Since 2015 it is a part of the Dechra Group.

For our Global Manufacturing Science & Technology Team we are looking for a:

Associate Formulator (m/f)

The Opportunity:

  • To provide the formulation support for executing new product commercialization projects from Dechra PD (Product Development) pipeline using product lifecycle approach
  • To provide the formulator support for executing optimization projects for currently approved products from site or from other internal sites or from CMOs (Contract Manufacturing Organizations) using product lifecycle approach
  • To provide the formulator support for troubleshooting currently commercialized problem products

The Challenge:

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, executes and implements scientifically well-designed experimental programs and demonstrates creativity and capability
  • 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 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, 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

About You:

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:
  • This is a formulator work, and relevant work experience combined with analytical knowledge, problem solving skills and the ability to plan and co-ordinate activities are more critical than academic qualifications. The ideal candidate will have a B.A., B.S., in life sciences, engineering, pharmaceutics, chemistry, or similar fields.
  • Minimum of 3 years in cosmetic/pharmaceutical development experience in formulation development or manufacturing in a variety of cosmetic/pharmaceutical dosage forms
  • Demonstrated success working in a cross-functional team environment on multiple projects
  • The position requires an understanding of the development, validation, verification and transfer of products, cGMP regulations, FDA and EMA regulations, and recent trends in product lifecycle concepts.
  • This individual should be able to recommend competent scientific judgments. Decisions must be made by this individual with the guidance of the MS&T Manager.
  • Strong verbal and written communication in English

To apply, please send us your CV and Cover letter in English via application link.

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