Manage analytical chemistry aspects of technology transfer for pharmaceutical products, overseeing project phases from development to commercialization, ensuring compliance with regulations and quality standards.
ROLE SUMMARY
The Manufacturing, Science & Technologies (MSAT) team oversees major process changes and provides technology and manufacturing support for products from R&D delivery to launch and throughout their lifecycle. They assist with new technologies, scale-up, troubleshooting, and process and cleaning validation.
The MSAT - Analytical Manager has overall responsibility for the analytical chemistry aspects of technology transfer of PGS and Pfizer CentreOne products from across all phases of development and through commercialization. In this position you will be both hands on in the laboratory and lead the Analytical team through all phases of projects including, analytical method development and validation, formulation development, process development and validation, cleaning validation, regulatory submission, technology transfer and commercialization.
As a member of the Extended Leadership Team (ELT), you will play a critical role optimizing the supply of world-class, life-saving medicines to our patients by leading cross-functional collaborations to build a culture of understanding, belief and a commitment to excellence; enabling timely decisions that are consistent with the site's goals, priorities and the Pfizer Blueprint; promoting Growth and Wellbeing by developing a strong culture of Recognition, Inclusivity, Equity and Diversity; fostering simplification, removing roadblocks and empowering continuous improvement and working as a cross functional cohesive team to build trust, Joy, excitement and knowledge.
ROLE RESPONSIBILITIES
In this role you will have an opportunity to:
culture of excellence.
QUALIFICATIONS
Essential
Bachelor's or higher degree in in Chemistry, Pharmacy or related field combined with at least 5 years'
experience within the pharmaceutical or allied industry.
Specialist technical skills and experience in pharmaceutical manufacturing, technology transfer, formulation development and process development.
Expertise in analytical method development and validation.
Knowledge and application of Good Manufacturing Practice and experience in dealing with Regulatory Authorities and Auditors.
Demonstrated Project Management skills with the ability to set, manage and deliver cross functional milestones on time.
Demonstrated management experience with a track record of establishing and/or leading effective teams that have contributed to organizational outcomes.
Results focused with demonstrated ability to meet business targets and objectives with strong customer focus.
Exceptional communication, negotiation, interpersonal & leadership skills (verbal and written).
Demonstrated ability to work under pressure and to agree on timelines with high attention to detail.
Desirable
Experience within Manufacturing, Process Validation or Quality departments preferred.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
(not all roles will have non-standard work schedule travel, or environment requirements)
Include any work schedule, travel or environment requirements necessary for the performance of the role. Types of requirements might include ability to work particular hours (shift, overtime), travel or adhere to safe work practices and procedures such as aseptic
gowning. Any criteria indicated must be job-related, consistent with business necessity, and specific to this role.
ORGANIZATIONAL RELATIONSHIPS
Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the role responsibilities. Include any external interactions as appropriate.
PSSM & Codev teams, MSAT, Project Management, External Contract Customers, Technology Transfer (GTEL), Contract Manufacturing, Manufacturing Operations, Material Management, Quality Assurance, Regulatory Affairs and R&D.
RESOURCES MANAGED
Financial Accountability
Indicate the Average Budget or Revenue accountability, as applicable.
Budget oversight of > $1M USD
Supervision
Indicate the typical number of Colleagues managed; include direct & indirect reports and matrix responsibility. Note if direct reports are people managers or individual contributors. Indicate additional resources (i.e. contingent workers) managed, as applicable.
Direct: Up to 5 direct reports
Work Location Assignment: On Premise
At Pfizer we care about our colleagues' wellbeing and offer a range of great benefits for them, including:
*Benefits listed may vary depending on your position and location and may be subject to change.
Pfizer Australia and New Zealand's diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.
If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.
Quality Assurance and Control
The Manufacturing, Science & Technologies (MSAT) team oversees major process changes and provides technology and manufacturing support for products from R&D delivery to launch and throughout their lifecycle. They assist with new technologies, scale-up, troubleshooting, and process and cleaning validation.
The MSAT - Analytical Manager has overall responsibility for the analytical chemistry aspects of technology transfer of PGS and Pfizer CentreOne products from across all phases of development and through commercialization. In this position you will be both hands on in the laboratory and lead the Analytical team through all phases of projects including, analytical method development and validation, formulation development, process development and validation, cleaning validation, regulatory submission, technology transfer and commercialization.
As a member of the Extended Leadership Team (ELT), you will play a critical role optimizing the supply of world-class, life-saving medicines to our patients by leading cross-functional collaborations to build a culture of understanding, belief and a commitment to excellence; enabling timely decisions that are consistent with the site's goals, priorities and the Pfizer Blueprint; promoting Growth and Wellbeing by developing a strong culture of Recognition, Inclusivity, Equity and Diversity; fostering simplification, removing roadblocks and empowering continuous improvement and working as a cross functional cohesive team to build trust, Joy, excitement and knowledge.
ROLE RESPONSIBILITIES
In this role you will have an opportunity to:
- Oversee MSAT- Analytical teams from project development phase through commercialization and lifecycle management phases.
- Manage resources to ensure programs have sufficient technical expertise to execute and implement.
- Ensure project technical milestones are completed according to plan; communicate issues as appropriate to manage Pfizer and customer expectations.
- Ensure timely and accurate execution of all laboratory based process validation and technology transfer testing.
- Identify and track variances to scope, timelines & costs and communicate this information during project reviews and planning cycles as required.
- Working collaboratively with the MSAT- Process team to design complicated formulation and process experiments that support fundamental process understanding of a product's physicochemical and stability characteristics.
- You will use your knowledge of the drug development process, clinical trial phases, regulatory strategies and product life-cycle to support development and commercialization strategies for Pfizer and customer pharmaceutical programs.
- In such a role you are responsible for solving complicated problems in analytical chemistry and support troubleshooting of formulation and manufacturing process issues.
- Develop and implement continuous improvement initiatives to enhance service levels and improve processes.
- Effectively delegate tasks and responsibilities, leveraging the strengths and capabilities of team members, while providing clear instructions, guidance, and support to ensure the successful completion of assigned tasks and the efficient utilization of resources.
- As a member of the extended Leadership team, participate in cross-functional activities to enable a
culture of excellence.
- Adhere to the spirit and practice of Pfizer Values, ensuring and promoting adherence to Pfizer's Environment, Health and Safety (EH&S) policies and procedures.
QUALIFICATIONS
Essential
Bachelor's or higher degree in in Chemistry, Pharmacy or related field combined with at least 5 years'
experience within the pharmaceutical or allied industry.
Specialist technical skills and experience in pharmaceutical manufacturing, technology transfer, formulation development and process development.
Expertise in analytical method development and validation.
Knowledge and application of Good Manufacturing Practice and experience in dealing with Regulatory Authorities and Auditors.
Demonstrated Project Management skills with the ability to set, manage and deliver cross functional milestones on time.
Demonstrated management experience with a track record of establishing and/or leading effective teams that have contributed to organizational outcomes.
Results focused with demonstrated ability to meet business targets and objectives with strong customer focus.
Exceptional communication, negotiation, interpersonal & leadership skills (verbal and written).
Demonstrated ability to work under pressure and to agree on timelines with high attention to detail.
Desirable
Experience within Manufacturing, Process Validation or Quality departments preferred.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
(not all roles will have non-standard work schedule travel, or environment requirements)
Include any work schedule, travel or environment requirements necessary for the performance of the role. Types of requirements might include ability to work particular hours (shift, overtime), travel or adhere to safe work practices and procedures such as aseptic
gowning. Any criteria indicated must be job-related, consistent with business necessity, and specific to this role.
- High potent and cytotoxic drug products handling and gowning procedures need to be followed per site procedure.
- Potential for early / late teleconferences outside of standard working hours
- Some travel may be required.
ORGANIZATIONAL RELATIONSHIPS
Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the role responsibilities. Include any external interactions as appropriate.
PSSM & Codev teams, MSAT, Project Management, External Contract Customers, Technology Transfer (GTEL), Contract Manufacturing, Manufacturing Operations, Material Management, Quality Assurance, Regulatory Affairs and R&D.
RESOURCES MANAGED
Financial Accountability
Indicate the Average Budget or Revenue accountability, as applicable.
Budget oversight of > $1M USD
Supervision
Indicate the typical number of Colleagues managed; include direct & indirect reports and matrix responsibility. Note if direct reports are people managers or individual contributors. Indicate additional resources (i.e. contingent workers) managed, as applicable.
Direct: Up to 5 direct reports
Work Location Assignment: On Premise
At Pfizer we care about our colleagues' wellbeing and offer a range of great benefits for them, including:
- Paid parental leave
- Access to Health & Wellness apps
- Career Growth Experiences program
- Recognition & rewards program
- Paid volunteer days
- Life Insurance Benefits
- Pfizer Learning Academy access to top content providers
- Access to flu vaccines & skin checks
- Options to purchase additional leave
- Salary packaging & novated lease options
*Benefits listed may vary depending on your position and location and may be subject to change.
Pfizer Australia and New Zealand's diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.
If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.
Quality Assurance and Control
Top Skills
Analytical Chemistry
Formulation Development
Good Manufacturing Practice
Pharmaceutical Manufacturing
Process Validation
Technology Transfer
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