Technical Operations Team Lead

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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The Technical Operations Team Lead is responsible for ensuring that manufacturing requirements for contracted clinical projects are executed safely, compliantly and efficiently. The role assists with translating the specific requirements for ensuring appropriate production techniques are deployed across PCI Melbourne. This is principally manufacturing drug product for clinical trials.

Manufacturing activities for clinical trials supported by the Technical Operations Team Lead consist of a variety of dosage forms and scales. Forms include capsule & sachet filling, tablet pressing and aseptic vial filling. Compounding can be based on liquid, powder or gel formulations, including use of controlled substances. Manufacture of matching placebo is often included in contracted studies. Batch sizes range from
5000 units.

A feature of the role is developing procedures and work instructions and reviewing master batch documents to ensure right the first time is introduced.

The Technical Operations Team Lead will also provide hands on technical training and support to production staff and will prepare training materials to embed technical knowledge within the team and drive the capability build of the team. The Technical Operations Team Lead will also support the introduction and technical understanding of new equipment introduced to the production department and will contribute to the recommendation of capital requirements.

Participate in technical investigations, root cause identification and CAPA determination, resolve process and equipment related issues, and participate and review validation protocols. Support Production Controllers and Supervisors to ensure that successful batch release is obtained.

Primary requirements of the role:

- Ensure that operations are conducted to quality requirements in accordance with cGMP/cGCP and relevant licenses
- Provide a safe working environment, adhering to Health, Safety and Environmental procedures and ensuring that all manufacturing minimises risk from exposure, manual handling and repetition.
- Contribute to items requiring inclusion in the operations capital plan.
- Providing operational and technical support with regards to the various aspects and phases of the production processes to ensure professional and timely execution of the production processes within the allocated resources and budgets.
- Continuously monitoring and evaluating the efficiency and effectiveness of the implemented methods and procedures.
- Provide technical support to GMP operations in a multi-product Sterile fill/finish and solid oral dose pharmaceutical manufacturing facility.
- Recommending appropriate training courses as per the pre-determined needs, evaluating their effectiveness, and monitoring their results.
- Identify, own and resolve process and equipment related issues proactively.
- Participate and review validation protocols (IOQ, OQ/PQ) and validation standards, validation statements, reports, summaries, and master validation plans for new customer / product / system project launch.
- Participate in Project Management, Client and Audit meetings where required.

Prior experience, knowledge and qualifications:

- Bachelor of Science, Engineering or equivalent
- Solid industry experience in pharmaceutical manufacturing
- Hands on experience with Oral Solid Dose and Aseptic product manufacturing
- Technical transfer experience from R&D into Production environment
- Ability to understand the role of quality within the manufacturing process which includes QMS and Validations
- Excellent written and verbal skills with good attention to detail
- Thorough understanding of Clinical Trial regulations in Australia
- Demonstrated team player that can coach and guide non-technical stakeholders

Core demonstrated behaviours:

- High level of professionalism, ethics, quality of work, communication and responsiveness at all times
- Positive, ‘can-do’ attitude, embraces and ‘lives’ PCI’s Vision and Values
- Analytical thinker and solution finder/problem solver
- Collaborative Leader and team player
- Objective and robust decision maker
- Self-confident and self-respectful
- Excellent interpersonal, written and verbal communication
- Self-motivated, achievement and outcomes orientated
- Trusting and trustworthy
- Conscientious and diligent
- Positively embraces and is responsive to change

Join us and be part of building the bridge between life changing therapies and patients.

Let’s talk future

Equal Employment Opportunity (EEO) Statement:

- PCI Pharma Services is an Equal _
- Opportunity/Affirmative_
- Action Employer. We do not unlawfully discriminate on the basis of race, c