Head of Production

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

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Head of Production holds primary responsibility for all manufacturing, labelling and packaging related activities across PCI Melbourne. This is principally manufacturing drug product for clinical trials including sterile fill finish as well as labelling and packaging for clinical trials. The Head of Production implements appropriate processes and practices to support all aspects of GMP as it relates to Production. This is primarily manufacture of drug product and placebo for contracted Clinical Study Projects. Executing against the site strategy, improving performance, ensuring standards are in place and met.
- Roles & Responsibilities:_
- Ensures 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 they are understood and practiced by team members at all times.
- Ensure Production schedules are set and delivered upon with contemporary supply chain metrics to measure performance.
- Ensure that all personnel are trained in accordance to GMP, EHS and specific operational procedures.
- Coach and mentor Production colleagues to develop their potential. Create a culture of accountability and high performance.
- Inventory systems are maintained in line with deliveries and material use. All controlled substances are logged, stored and deployed as per regulations.
- Ensure that all relevant procedures and processes are followed and adhere to in line with the company’s procedures and requirements.
- Manage budget on capital, headcount & overtime budget for the production team.
- Deliver efficiencies to support year on year operational budget reduction. Use Lean Management principles.
- Act as Operational sponsor for capital plans.
- Lead and champion continuous improvements to achieve exceeded operational excellence.
- Participate in Project Management, Client and Audit meetings where required.
- Act as key team member in performing due diligence on production related tasks on any mergers & acquisitions of the business.
- Adhere to any planning and scheduling requirements as per client and business requirements.
- Any other tasks/projects as required by Manager.
- Your skills and experience:_
- 15 + years of previous industry experience in pharmaceutical production management within a global organisation.
- Previous experience in a leadership role with managing large number of direct & indirect reports.
- Hands on experience with Oral Solid Dose and Aseptic product manufacturing.
- Prior experience with Sterile Fill Finish.
- Demonstrated Lean Management expertise.
- Excellent written and verbal skills with good attention to detail.
- Bachelor of Science, Engineering or equivalent.
- Thorough understanding of Good Manufacturing Practice
- 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

At PCI we are committed to creating a supportive and inclusive workplace where every individual feels they can be their full selves.

We are an equal opportunity employer; seeking people from all life stages, background and life perspectives.

PCI does not discriminate on grounds of race, religion or belief, ethnic or national origin, disability, age, marital, domestic or civil partnership status, sexual orientation, gender identity, or any other basis as protected by applicable law and we believe that Equal Employment Opportunity is a matter of employment obligation, social justice and legal responsibility that we uphold and take seriously.

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

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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, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._