Product Development Project Manager

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

The Role

We are seeking a newly created role for an experienced Product Development / Project Manager to lead the development and implementation of new products lines at our expensive Old Toongabbie manufacturing plant. This role will be responsible for managing all aspects of the product development lifecycle, ensuring compliance with regulatory requirements whilst delivering successful commercial outcomes.

You will come with proven experience in pharmaceutical manufacturing processes and product development backed by a strong understanding of regulatory requirements and quality assurance standards. Excellent leadership, collaboration, and communication skills are a must.  You will work alongside our production and engineering teams in a fast-paced environment, utilising your strong analytical and problem-solving skills while prioritizing multiple tasks.

Responsibilities

• Lead the end-to-end project management of product development

• Develop detailed project plans with clear achievements, deliverables, and critical paths

• Coordinate cross-functional teams, including engineering, supply chain, quality assurance, operations, validation, and regulatory departments as required

• Ensure all designs and implementations align with cGMP, TGA, and other relevant regulatory requirements

• Evaluate the specification, procurement, installation, and qualification of automated filling equipment

• Develop and implement validation protocols

• Initiate and project manage supply chain and financial processes such as master data creation, BOM development, cost of goods evaluation, and forecast development

• Manage risk assessment and mitigation strategies throughout the project lifecycle

• Build and maintain project documentation, including change control, deviation management, and validation documentation

• Report project status, issues, and recommendations to executive leadership.

Key requirements

• Tertiary degree in Engineering, Pharmaceutical Sciences, or a related technical field

• PMP certification is highly desirable

• 7+ years of experience in pharmaceutical manufacturing environments

• Proven project management experience in the pharmaceutical/biotech industries

• Proven experience of clean room facility projects and automated filling line operations.

• Strong understanding of pharmaceutical quality systems and cGMP requirements

• Demonstrated experience with validation protocols (IQ/OQ/PQ) for pharmaceutical manufacturing equipment

• Knowledge of relevant regulatory requirements for pharmaceutical production

• Experience with change management and process improvement methodologies

• Proficiency in MS Office suite and relevant engineering/design software

• Excellent leadership, collaboration, and communication skills

• Ability to work effectively in a fast-paced environment and prioritize multiple tasks

• Strong analytical and problem-solving skills.

Why Baxter?

At Baxter ANZ, we are focused on being a Best Place to Work where our people can be their authentic self, feel valued and respected. We are committed to a culture where all employees can collaborate and work together effectively. Relationships are a key component in how we operate in Baxter and we share the common traits of being reliable, ethical, caring, having empathy, actively listening to our colleagues as well as being open minded to new ideas and perspectives. Baxter is an organisation that makes inclusion and diversity a priority and that seeks to promote and improve gender equality in the workplace.

Baxter is proud to be recognized as an Inclusive Employer by the Diversity Council of Australia. We are also committed to delivering support structures for working families; stronger actions to address pay inequalities; and strategic recruitment and promotion practices that help to encourage the full participation of all people at work.

Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or any other status protected by law. Baxter encourages applicants of all ages.

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Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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