What are the responsibilities and job description for the Batch Release Specialist position at CSL?
Position Purpose
The Batch Release Associate is accountable for continued supply for the supply of CSL's early and late stage clinical trials worldwide. This role serves as a Release Responsible/Authorized Person for IMP for ROW and is direct Quality Assurance partner with Clinical Trial Supply (CTS) with specific quality oversight of GxP Compliance (i.e., GCP, GMP, GDP, etc.).
Reporting Relationships
The role reports to: Head of Clinical Trial Supply
The role has no direct line management responsibility
Main Responsibilities And Accountabilities
1.Generate and review batch documentation as well as perform batch release actions to assure the continued uninterrupted supply of CTM from Technical release of in-process intermediates, drug substances to drug product and final packed and labeled IMP.
Education
University degree (BSc, MSc, PhD) in life sciences, engineering, logistics or equivalent experience
Experience
Minimum of 5 years experience in clinical supply management, clinical research, product development and/or global R&D project management in the biopharmaceutical industry including 2 years in clinical drug supply roles with global responsibility
Competencies
Required
Travel approximately 20%.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
The Batch Release Associate is accountable for continued supply for the supply of CSL's early and late stage clinical trials worldwide. This role serves as a Release Responsible/Authorized Person for IMP for ROW and is direct Quality Assurance partner with Clinical Trial Supply (CTS) with specific quality oversight of GxP Compliance (i.e., GCP, GMP, GDP, etc.).
Reporting Relationships
The role reports to: Head of Clinical Trial Supply
The role has no direct line management responsibility
Main Responsibilities And Accountabilities
1.Generate and review batch documentation as well as perform batch release actions to assure the continued uninterrupted supply of CTM from Technical release of in-process intermediates, drug substances to drug product and final packed and labeled IMP.
- Perform oversight of deviations, corrective/ preventative actions (CAPAs) and effectiveness checks impacting all aspects of CSL IMP
- Ensures that IMP is labelled and packed consistent with clinical trial designs, in accordance to CSL release specifications, regulations and international and local standards and requirements
- Provide Quality oversight to transport verification on shipments of clinical material to depots.
- Assure proper QMS documentation is generated to accompany lot releases.
- Collaborate with CTS personnel and relevant Quality units to ensure proper and timely processing of PTCs.
- Ensure appropriate maintenance/ administration of BT systems (i.e., Plateau, ODRS and TrackWise) used in support of Clinical Supply Quality.
- Oversee and ensure compliance to GMP/GSP or other GxP requirements
- Review of GMP and non-GMP batch documentation supporting CTM product release
- Review of batch documentation for systems checks
- Provide Quality oversight and strategic guidance to R&D change controls, deviations, observations and out of specifications activities, as appropriate to assure proper documentation review and completeness within QMS
- Perform relevant change control implementation tasks
- Provide support during audits and inspections
- Participate in vendor audits as Subject Matter Expert for CTS-related audits
- Support the global CTS team to prepare for internal audits and Competent Authority (CA) Inspection related activities
- Support Quality Oversight of relevant third-party vendors
- Review /Revise Quality Agreements to ensure CSL and Regulatory requirements are maintained
- Acts as preliminary escalation point for CTS in case of vendor specific Quality complaints
- Provide guidance to R&D departments regarding quality related issues with batch documentation as well as associated deviations, change controls and out of specifications
- Ensures an effective operating model for partnering with CTS vendors, including processes, standard operating procedures, work instructions, roles and responsibilities, and electronic data exchange/system interfaces. Oversees implementation at all CTS vendors.
- Support development and implementation of standards across CTS vendors (e.g. packaging & labeling standards, distribution & return standards, and deviation management).
Education
University degree (BSc, MSc, PhD) in life sciences, engineering, logistics or equivalent experience
Experience
Minimum of 5 years experience in clinical supply management, clinical research, product development and/or global R&D project management in the biopharmaceutical industry including 2 years in clinical drug supply roles with global responsibility
Competencies
Required
- Comprehensive understanding of global clinical trial and clinical supply chain processes
- Knowledge and experience in GCP/GMP/GDP principles including relevant international standards and regulatory requirements/regulations related to clinical development
- Strategic thinking and development
- Vendor management and governance
- Demonstrated experience leading process improvement projects
- Analysis, problem solving, judgement and sound decision-making skills
- Ability to collaborate across all levels within the organization and with external parties
- Effective interpersonal, negotiation and influencing skills
- Excellent English language written and oral communication and presentation skills
- Customer focus
Travel approximately 20%.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.