Manager: Biologicals

SUMMARY:
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POSITION INFO:

Location: Sandringham
Contract Duration: 6-Month Fixed-Term Contract

Purpose of the Role

An exciting opportunity exists for an experienced Biologicals Manager to oversee biologicals production, quality control, and laboratory operations. The successful candidate will ensure the delivery of high-quality, cost-effective biological products while maintaining compliance with Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and relevant regulatory requirements.

Key Responsibilities

• Manage the day-to-day activities of biologicals operations, including animal facilities and quality control functions.

• Ensure the production of high-quality biological products in compliance with GLP, GMP, and industry regulations.

• Lead research, development, and implementation of new technologies, testing methods, and laboratory processes.

• Provide technical and operational guidance relating to laboratory, manufacturing, and immunological processes.

• Oversee quality management systems, including change controls, deviations, CAPAs, validation protocols, and standard operating procedures.

• Ensure quality and operational systems are maintained and continuously improved.

• Design and implement testing calculations, spreadsheets, specifications, and SOPs to support data integrity and compliance.

• Liaise with regulatory and professional bodies to ensure compliance with current legislation and best practices.

• Manage relationships with suppliers, service providers, and external stakeholders.

• Oversee budgets, contracts, performance, and quality requirements of venom and biological material suppliers.

• Collaborate with external research institutions on product development, efficacy studies, and research projects.

• Drive operational efficiency and continuous improvement initiatives within the division.

Minimum Requirements

Qualifications

• Four-year Degree or Diploma in:

  • Pharmacy (B.Pharm), or

  • Health Sciences, Healthcare Technology, Microbiology, Immunology, or related field.

• Registration with the relevant professional council as applicable.

Experience

• Minimum 6 years' post-qualification experience within a pharmaceutical manufacturing environment, preferably biologicals.

• Experience in immunological process management.

• Working knowledge of GMP and GLP requirements.

• Experience in Quality Control testing and validation processes.

• Knowledge of Occupational Health and Safety requirements.

• Exposure to budgeting and financial management.

• Understanding of research methodologies and statistical analysis.

Required Skills

• Biologicals and pharmaceutical manufacturing expertise

• Quality assurance and quality control

• GMP and GLP compliance

• Immunology and microbiology knowledge

• Research and development

• Validation and regulatory compliance

• Leadership and people management

• Analytical and problem-solving skills

• Financial and budget management

• Strong verbal and written communication skills

• Computer literacy (MS Office and laboratory systems)

Ideal Candidate

The ideal candidate will have strong leadership skills, extensive experience within pharmaceutical or biological manufacturing environments, and the ability to manage quality-driven operations while ensuring regulatory compliance and operational excellence.

Contract: 6 Months Fixed-Term
Location: Sandringham
Experience Required: 6+ Years
Industry: Pharmaceutical / Biological Manufacturing