Analytical Services Team Lead

2 months ago

Thebarton, Australia BioCina Pty Ltd Full time

**About BioCina**

BioCina is a biologics contract development and manufacturing organization (CDMO) specializing in process development and cGMP manufacture of microbial-based therapeutics and plasmid DNA, from preclinical to commercial production. The site, approved by the FDA for commercial manufacturing in 2020, has 35+ years of microbial fermentation experience and over the past 15 years, has worked on over 50 different products and has partnered with more than 30 customers globally.

We are looking for an **Analytical Services Team Lead** to provide technical support to the Quality Control department and BioCina’s CDMO clients in the areas of method transfer, qualification, validation, lab investigations and troubleshooting to ensure efficient result and right first-time delivery through implementation of scientifically sound and robust test methods into Quality Control from clients or BioCina’s Analytical Development team.

**Responsibilities**
- Authoring of method transfer, qualification and validation protocols and reports.
- Authoring, review and/or approval of documents, including test methods, SOP’s, protocols, reports etc.
- Review of laboratory trends, author and review of annual reports to identify and implement improvements.
- Monitor compendial and regulatory trends and updates and review against site processes and ensure continued compliance.
- Lead laboratory investigations and assist in troubleshooting analytical issues.
- Identification and implementation of process efficiencies/continual improvements, new equipment and/or techniques to the QC laboratory.
- Assist in the coordination and leadership of the QC department, including scheduling of laboratory activities and provide training, coaching, and mentoring to QC staff.
- Approve and release of in-process results to production and interact with clients/customers on projects as required.
- Compliance with site quality management systems and procedures; training, investigations, corrective and preventative actions, exception reports, internal and external audits, cGxP (cGMP, cGDP, cGLP).
- Responsible for taking reasonable care of self and others and obey any reasonable instruction aimed at protecting health and safety while at work. Adhere to all safe working policies and procedures in accordance with instructions.

**Requirements**:

- Bachelor’s or master’s in a scientific or engineering discipline.
- Minimum 5 years of working experience with analytical techniques, as HPLC experience is highly desirable.
- Proven ability to collate, analyse and interpret data and information.
- Knowledge of analytical data packages, e.g., Empower is preferred.
- Extensive laboratory experience and ability to prioritize and manage multiple tasks effectively.
- Knowledge of cGxP and aseptic techniques and experience working in a CDMO QC environment.
- Exceptional attention to detail regarding documentation.
- Excellent communication skills and ability to work as part of a highly skilled Validation team.

**Why work with BioCina?**
- Competitive remuneration and benefits: We offer a competitive salary, comprehensive benefits package, and recognition for exceptional performance.
- Career growth opportunities: We believe in growing our people and provide ample opportunities for career development and advancement.
- Innovation and impact: Be part of a company that goes beyond the boundaries of science and making a positive impact on patients’ lives.
- State-of-the-art facility: Utilise cutting-edge technology and work in a modern, well-equipped facility that fosters creatively and productivity.
- Collaborative environment: Work alongside with passionate and expert professionals who are dedicated to excellence and shared a common goal.

Join our team and help shape the future of biopharmaceuticals. Together, we can make a difference.

**Salary**: $60,164.93 - $121,495.05 per year

**Benefits**:

- Maternity leave
- Parental leave
- Professional development assistance

Schedule:

- Day shift

Supplemental pay types:

- Annual bonus

**Education**:

- Bachelor Degree (required)

**Experience**:

- Biotechnology: 3 years (required)

Work Authorisation:

- Australia (required)

Ability to Commute:

- THEBARTON, SA 5031 (required)

Ability to Relocate:

- THEBARTON, SA 5031: Relocate before starting work (required)

Work Location: In person

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