Principal Scientist, Formulation Development
|Contact Name:||Larry O’Leary|
Our client is a global leader in veterinary medicine, rapid expansion through a combination of outstanding innovation from its own research and development team as well as its own organic growth has led to vacancy for Principal Scientist role. This individual contributor role will provide technical formulation expertise in delivery of new product projects from pre-formulation through to VICH manufacture and regulatory submission.
This role will support the Head of Product Development; who has responsibility for Formulations, Analytical Laboratories and R&D Technical Services; in the development, scale-up and characterisation of new product formulations.
The successful candidate will provide Subject matter expertise (SME) in the areas of new product formulations & development, technology and process validation, optimisation and scale-up, and new product stability.
The ideal candidate will be an experienced Formulation Scientist in supporting product development lifecycle, from pre-formulation through to regulatory submission.
Responsibilities for Principal Scientist, Formulation Development:
Preparation and development, scale-up and characterisation of new product formulations, processing methods of a range of products for clinical bio-studies, based on existing company methodologies.
Support analytical method development and method validation programmes, ensuring methods are robust and transferrable.
Provide effective support of tech transfers, ensuring effective transfer of products from the lab to both pilot and commercial scale within the production facilities. Products have included solid oral dosage forms, oral solutions/suspensions, sterile injectables and Intra-mammary dosage forms.
Participate in the troubleshooting of product/method issues as part of lifecycle management.
Ensure compliance with ICH/VICH, QbD, EMA and FDA guidelines in relation to product development, validation, quality management systems and stability in support of product registration and commercialization.
Assist in the recruitment, training and development of formulation team members.
All activities will be executed in accordance with the Company’s Quality Manual, SOPs, and the quality standards set by the company.
Requirements for Principal Scientist:
Bachelors Degree in Pharmacy, Drug Development, Analytical Development/Chemistry or related Scientific subject.
5+ years’ experience in regulated environment, with demonstrable experience in formulation of both sterile and non-sterile dosage forms.
Demonstrable experience in developing and validating analytical methods.
Experience of leading multi-functional formulations and analytical development projects.
Expertise with HPLC, UPLC techniques.
Experience in supporting the CMC component of regulatory filings.
Experience in Technology Transfer with scale up from laboratory to commercial manufacture.
Experience in the trending and interpretation of analytical data.
Excellent oral and written communication skills.
For further details, please contact on Larry on +353 (0)1-2302400 / firstname.lastname@example.org
The RFT Group: Biopharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie / www.meddevicejobs.ie
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