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Pharmaceutical Sourcing Manager – Biotech GMP Facility (The position has been filled)
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High Profile Biotech Company Developing New Pharmaceutical Products
Our client is a well known, successful biotechnology company based in Melbourne’s CBD. Due to the success of their innovative products, they continue to grow and excel.
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.
Our client has a newly created role for an experienced Sourcing Manager to be responsible for the identification and procurement of active pharmaceutical ingredients (API), excipients, components, packaging and other key materials to support pharmaceutical development programs leveraging market intelligence.
The successful candidate will also be responsible for developing cost reduction strategies, leading supplier contract negotiations, ensuring materials are suitable and meet regulatory requirements and provide information for regulatory dossier compilations.
Some of the key duties will include:
Procure materials that are of a pharmaceutical grade and meet regulatory requirements ie GMP, DMF, FDA
Organise timely procurement and transfer of materials to contract manufacturing organisation (CMO)
Liaise with the Formulation team for timely Bill of Materials (BOM)
Drive the API sample testing schedule with the Analytical team and present results for selection
Manage the API and other materials from a procurement perspective, including dealing with legal and regulatory aspects of the shipment, customs, licensing and any other import issues as they might arise
Initiate Vendor Assurance, Supply Agreements, Quality Agreements with QA Department; and Credit Terms and Conditions, as required
Assist Quality Department in supplier audits, investigation complaints, change control and GMP systems monitoring
Work closely with Project Teams and maintain open and on-going communication with internal stakeholders regarding forward planning for production schedules, suppliers, key negotiations, performance and lead times.
International travel to conduct audits, negotiations, etc as required
To be successful in your application you will need to meet the following criteria:
Tertiary qualification in Science or Procurement or related discipline.
Minimum of 5-8 years’ experience in pharmaceuticals procurement. Experience within a company developing generic pharmaceutical topical drug products will be highly regarded.
Purchasing and sourcing experience in the pharmaceutical or related industry.
Excellent computer MS office experience in particular WORD and EXCEL.
Proven track record in supplier management and negotiation.
Technical/scientific understanding of API’s and GMP regulatory environment.
Experience in managing third party providers
Ability to communicate and negotiate effectively with internal and external customers.
High quality work standards with a high attention to detail.
Strong knowledge of GMP, SOPs, Quality Assurance systems, Quality audits, and supplier qualification programs.
Experience with MYOB is desirable but not essential.
Effectively able to communicate with suppliers and internal stakeholders; and efficiently respond to queries.
Effective relationship management, negotiation and conflict resolution skills.
Excellent planning and organisational skills with atention to detail whilst able to multi-task and prioritise.
Ability to ensure compliance with GLP, cGMP, Company Validation Master Plan, pharmacopeia, relevant internal and external policies (including the Company Quality Manual), quality systems, SOPs, lists, methods & regulatory authority requirements.
Ability to think clearly and logically in a challenging environment as well as trouble shoot and solve technical problems.
Please click the ‘Apply Now’ button to submit your application. Please ensure you attach a Resume and Cover Letter in Word Format addressing the full selection criteria.
If you would like to know more about this unique opportunity please call our team at CS Executive Group on 03 9516 0100. After hours you can call Helen on 0438 620 434.
We would like to thank you for taking the time to apply for this role. Unfortunately, due to the large volume of applications we receive daily, we cannot contact all candidates. Please note, if you are not successful on this occasion, your resume will remain on our database and you may be contacted for other similar roles in the future.