R&D Manager – Biotechnology

R&D Manager – Biotechnology (The position has been filled)

• Manage the formulation & preclinical development of specialty & generic products
• Excellent opportunity for a senior manager to join an ASX listed company
• CBD location, excellent culture & negotiable salary with benefits

 

OUR CLIENT

Our client is a pharmaceutical company specialising in the development and commercialisation of topical pharmaceuticals. Utilising in house facilities and capabilities, the company continuous to successfully develop and commercialise a number of affordable generic products for the US and EU markets.

Boasting modern facilities and state of the art laboratories, our client offers a friendly, supportive work environment and access to parking as well as public transport.

 

THE ROLE

Due to an internal promotion, our client requires a professional with experience in generic pharmaceuticals. The ideal person will have experience in project management, FDA regulations, a broad knowledge of the global pharmaceutical competitive environment, preclinical guidelines and formulation development.

This role manages and facilitates all of our client’s formulation development, including preclinical development of specialty and generic pharmaceutical products in accordance with regulatory requirements for USA, European and other markets. The position is responsible for the planning and conduct of in vitro (IVRT/IVPT) development and validation studies including pilot and pivotal bioequivalence studies.

Leading and managing a formulation team of eight, you will actively participate in project team meetings in order to facilitate the development of products and oversee transfer of manufacturing methodologies and process parameters to CMOs.

 

SELECTION CRITERIA

To be short-listed for this senior role you will need to meet the following criteria:

• Bachelor of Pharmaceutical Science, Formulation Science or equivalent degree. PM certification and/or MBA highly regarded but not essential
• extensive experience in formulation of new and generic semisolid and topical dosage forms of pharmaceutical products including in vitro development
• a solid understanding of quality by design and statistics
• excellent communication, presentation organisational and time management skills
• an understanding of intellectual property, project management and FDA regulations
• able to travel internationally to facilitate technical transfer

 

APPLICATIONS

For a confidential discussion about this exciting opportunity please contact Helen Patronis on 0438 620 434.

To apply for this role, please click the ‘Apply Now’ button then send your current resume and a cover letter to CS Executive Group.

 

THANK YOU

CS Executive Group would like to thank you in advance for taking the time to apply for this role. Unfortunately, due to the large volume of correspondence our recruitment team receives on a daily basis, we genuinely cannot respond to each application—only those applicants being considered for shortlisting as candidates are contacted.

However, if on this occasion you’re unsuccessful, please note your details will be added to our Talent Pool database.