BioCina is a global end-to-end Contract Development and Manufacturing Organisation (CDMO) offering clients unparalleled quality, adherence to the highest regulatory standards, and industry-leading on-time and in-full delivery, setting a new benchmark in the industry for quality and reliability. With deep expertise in small molecules, microbial, pDNA, and mRNA modalities, BioCina’s comprehensive service offerings include cell line development, process development, analytical and formulation development, and cGMP clinical and commercial manufacturing. BioCina operates two state-of-the-art facilities in Adelaide, South Australia, and Perth, Western Australia.

As one of the fastest-growing companies in the biopharmaceutical industry across Australia, BioCina was awarded the 2024 South Australia “Emerging Business of the Year” award.

Job Overview:

The Aseptic Specialist will be responsible for integrating and implementing aseptic techniques and microbiological processes for new clients and projects within the pharmaceutical industry. This role focuses on developing and optimising microbiological controls, environmental monitoring, and aseptic processes tailored to new clients’ product, ensuring compliance with regulatory standards and supporting successful project completion.

This position requires strong expertise in microbiology, aseptic, project management skills, and the ability to collaborate with cross-functional teams to introduce new processes and establish robust contamination control practices.

Responsibilities:

Project Engagement:

Collaborate with project teams and new clients to understand specific microbiological requirements for their product pipelines.

Act as the subject matter expert (SME) for aseptic processing and microbiological concerns during project scoping, ensuring the client’s requirements align with internal capabilities.

Ensure all new aseptic and microbiological processes comply with industry standards and regulatory requirements (e.g., GMP, FDA, EMA) from project initiation to completion.

New Process Development:

Lead the design and implementation of new aseptic processes, tailored to the needs of new clients and projects.

Work closely with process development and production teams to establish microbiological control points for new product lines.

Validate new aseptic processes, cleanroom environments, and microbiological testing methods according to regulatory guidelines (GMP, FDA, EMA), including Media Fills.

Aseptic Technique and Process Implementation:

Oversee the integration of aseptic techniques into manufacturing processes for new products, ensuring sterile conditions are maintained.

Develop SOPs for new aseptic processes and ensure training for operational staff to meet client-specific needs.

Support the scale-up of aseptic operations, providing guidance on contamination risk and mitigation strategies during new client onboarding.

Environmental Monitoring Program Expansion:

Expand and adapt the environmental monitoring program to meet the unique demands of new client projects and products.

Design and implement new monitoring protocols for cleanroom environments and aseptic areas, ensuring regulatory compliance.

Review environmental data and trends to proactively address contamination risks during project launches.

Microbiological Testing:

Develop and implement microbiological testing protocols (e.g., sterility, bioburden, endotoxin) customised for new client projects.

Ensure timely and accurate microbiological testing for new product lines to meet project timelines and regulatory compliance.

Review and analyse test results, providing data-driven insights to both internal teams and clients regarding product quality and safety.

Qualifications:

Education: Bachelor’s or Master’s degree in Microbiology, Biology, Biotechnology, or related scientific discipline.

Experience:

5+ years of experience in microbiology and aseptic processing, with a focus on new project and process development.

Proven experience in supporting new client projects, from initiation to process validation.

Strong knowledge of regulatory guidelines (GMP, FDA, EMA) in the context of aseptic and microbiological processes.

Skills:

Ability to manage multiple projects and adapt processes to new client requirements.

Excellent problem-solving skills, with a focus on contamination risk assessment and mitigation.

Strong communication and client-facing skills to explain technical concepts clearly and build client confidence.

Preferred Skills:

Project management experience, particularly in introducing new processes for sterile manufacturing.

Expertise in implementing rapid microbiological testing methods and new environmental monitoring technologies.

Experience with quality systems and documentation management (e.g., LIMS, QMS).