We need an experienced full-time Development Projects Manager for a permanent role. As a key person in the CMC/Nonclinical team, you will:- Manage, support and oversee various Chemistry, Manufacturing and Controls (CMC) and nonclinical activities and studies associated with the advancement of medical device and drug development projects.- Proactively manage timelines, technical requirements and deliverables for projects through effective supplier management, and via collaborative interactions with the CMC/Nonclinical team, and internal Development and Discovery customers.- Ensure that projects, studies and testing appropriately address the required technical and regulatory aspects and are conducted within an appropriate commercial framework.
REQUIREMENTS
Our ideal person will meet the following criteria:
Minimum of a BSc or Honours in Chemistry, Biochemistry, Pharmacy or related field. PhD will be well regarded but Bachelor/Honours with extensive relevant experience will be equally well regarded
Five to ten years' experience in a CMC role that has strengthened and proven your ability to project manage development programs. Your background includes experience in a pharmaceutical product development setting conducting or overseeing manufacturing processes, packaging, labelling and distribution activities, and nonclinical studies, including critical technical review of batch records and manufacturing documentation, and study protocols and reports.
Knowledge and/or experience in the various CMC regulatory requirements (eg, ICH, FDA 21 CFP, GLP, GMP, ISO 13485 regulations) for the development and registration of drug substances and products
Strong project management and organisational skills including project plan development and maintenance and the ability to keep detailed records
Excellent analytical acumen and attention to detail
Knowledge or general understanding of synthetic chemistry, or the various chemical and analytical methodologies relating to drug manufacture, drug characterization and stability assessment (eg, process chemistry, HPLC, LC/MS)
Key to this role is your flexible "can do" attitude, excellent work ethic, initiative and responsiveness. You are equally happy to work autonomously and as part of a collaborative team.
Starpharma offers an attractive remuneration package (including cash bonus and employee equity scheme), a down to earth and collegiate work culture with highly diverse workforce, and a popular Health & Wellbeing program with activities across the year. We are based in the vibrant Abbotsford precinct between Victoria St and the Yarra River.
To apply for this role, please send a cover letter and your CV to [email protected].
SPL Price at posting:
$1.20 Sentiment: Buy Disclosure: Held
