What are the responsibilities and job description for the Supervisor, Global Sample Administration position at Kindeva Drug Delivery Careers?
Kindeva Drug Delivery
Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
Job Summary:
The Supervisor, Global Sample Administration is a key supervisory role in the Global Lab Services Organization under the Analytical Services business unit. This role will be responsible to create and enforce harmonized robust processes for the overall lifecycle for samples as part of testing and projects within our global Analytical Services organization. This role will maintain DEA Power of Attorney and all processes related to the management, storage and use of controlled substances. The Global Sample Admin team will manage both internal and external customer samples associated with global projects. This role also includes shipping and receiving activities associated with all materials sent and received by Analytical Services and Development.
Essential Job Functions:
Create, execute and maintain global sample administration processes for harmonization and transparency of sample life cycle. This includes the creation of appropriate SOPs and WIs
Supervise and maintain sample chain of custody processes to ensure compliance and efficiency
Provide direction, oversight and development of team members within the global Sample Admin team
Support the development of system process to automate sample and project handling
Work closely with Project Managers and Lab Operations to provide visibility to sample disposition
Supervise and maintain all sample records as received and stored and shipped
Responsible for the coordination, maintenance, and final disposition of all samples received within Analytical Services and Development global lab sites through supervision of the Global Sample Admin team
Manage and communicate the role & responsibilities of the Sample Admin team to effectively deliver sample activities in accordance with current Regulatory, GMP, business guidelines.
Facilitate, drive and take responsibility for timely decision-making and resolution of conflicts within the Sample Admin team and raise issues to appropriate management level when needed
Work with EHS to ensure that all samples are received, opened and stored utilizing the appropriate location and PPE
Ensure safe practices that support the shipping of samples and materials to 3rd party vendors, customers and internal sites
Responsible for all activity and procedures for DEA controlled substances including developing of support team, inventory and audits/inspections
Oversee Class 10,000 ISO GMP cleanroom through documentation, procedures and direction to the Metrology team for overall maintenance
Responsible to track all agreed KPIs and report as per agreed time schedule
Continuously improve sample management processes and log lessons learned to share key learning and insights within the organization in support of collective knowledge bases
Other responsibilities as assigned
Minimum Requirements:Minimum Education requirements:
Other Skills required: (computer, language, etc.) Microsoft Office Suite including strong communication and presentation skills
#LI-On-Site
California residents should review our Notice for California Employees and Applicants before applying.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
Job Summary:
The Supervisor, Global Sample Administration is a key supervisory role in the Global Lab Services Organization under the Analytical Services business unit. This role will be responsible to create and enforce harmonized robust processes for the overall lifecycle for samples as part of testing and projects within our global Analytical Services organization. This role will maintain DEA Power of Attorney and all processes related to the management, storage and use of controlled substances. The Global Sample Admin team will manage both internal and external customer samples associated with global projects. This role also includes shipping and receiving activities associated with all materials sent and received by Analytical Services and Development.
Essential Job Functions:
Create, execute and maintain global sample administration processes for harmonization and transparency of sample life cycle. This includes the creation of appropriate SOPs and WIs
Supervise and maintain sample chain of custody processes to ensure compliance and efficiency
Provide direction, oversight and development of team members within the global Sample Admin team
Support the development of system process to automate sample and project handling
Work closely with Project Managers and Lab Operations to provide visibility to sample disposition
Supervise and maintain all sample records as received and stored and shipped
Responsible for the coordination, maintenance, and final disposition of all samples received within Analytical Services and Development global lab sites through supervision of the Global Sample Admin team
Manage and communicate the role & responsibilities of the Sample Admin team to effectively deliver sample activities in accordance with current Regulatory, GMP, business guidelines.
Facilitate, drive and take responsibility for timely decision-making and resolution of conflicts within the Sample Admin team and raise issues to appropriate management level when needed
Work with EHS to ensure that all samples are received, opened and stored utilizing the appropriate location and PPE
Ensure safe practices that support the shipping of samples and materials to 3rd party vendors, customers and internal sites
Responsible for all activity and procedures for DEA controlled substances including developing of support team, inventory and audits/inspections
Oversee Class 10,000 ISO GMP cleanroom through documentation, procedures and direction to the Metrology team for overall maintenance
Responsible to track all agreed KPIs and report as per agreed time schedule
Continuously improve sample management processes and log lessons learned to share key learning and insights within the organization in support of collective knowledge bases
Other responsibilities as assigned
Minimum Requirements:Minimum Education requirements:
- Graduate - Science or engineering based is preferred but not essential
- Approximately 10 years of experience in pharmaceutical or medical device industry
- Knowledge/experience of pharmaceutical product development, from concept through to product launch
- Good Pharma knowledge and experience of pharma product development from concept to submission
- Strong knowledge and awareness of GMP sample handling including DEA practices
- Cross functional team leadership experience
Other Skills required: (computer, language, etc.) Microsoft Office Suite including strong communication and presentation skills
#LI-On-Site
California residents should review our Notice for California Employees and Applicants before applying.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
