Senior Group Leader - Lab Supervisor, Biopharmaceutical Testing

Pharmaceutical Product Development (PPD)

WI-Middleton-Middleton WI Research Way


Submission for the position: Senior Group Leader - Lab Supervisor, Biopharmaceutical Testing - (Job Number: 171627)PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!  

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success. 

As a Senior Group Leader you will provide oversight and supervision of staff and resources performing pharmaceutical development studies such as method development and validation, stability, QC, etc.  

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.  

Summarized Purpose:

Provides oversight and supervision of staff and resources performing pharmaceutical development studies such as method development and validation, stability, QC, etc. Manages the work activities of group and associate group leaders, resource planning and allocation, client communication, technical document generation and review, mentoring technical staff and troubleshooting method and product-related issues. Ensures the compliance of work performed within the laboratory as well as working with manager to meet the financial goals of the organization.

Essential Functions:  

Reviews and approves study protocols, project status reports, final study reports and other project related technical documents. Designs experimental studies and participates in technical troubleshooting. Allocates, schedules and manages laboratory resources for group's project activities and updates project status and revenue projections. Reviews timesheet reports for billing accuracy. Reviews data for technical quality and compliance to protocols, methods and SOPs. Approves laboratory investigations, deviations, QA facility and data audits. Leads client and FDA audits. Responds to clients questions and needs; leads client technical meetings. Provides recommendations to clients on analytical and compliance issues. Prepares and approves proposals, project definition and pricing. Participates in project definition and negotiations with client on timelines and budget. Identifies business opportunities at conferences, workshops, within the community, through client interaction, etc. Participates in technical sales and marketing; prepares technical marketing materials. Works with business development as technical representative for client visits/discussions. Prepares and implements PPD SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvements. Accountable for group's knowledge and application of good practices pertaining to GMP/GLP and / or other laboratory / client requirements. Participates in bi-annual SOP review & change. Ownership of changes needed to comply with SOPs. Regularly communicates to staff quality related issues and items for staff development and implements quality improvements.

#LI-33456501_TG1

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!  

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success. 

As a Senior Group Leader you will provide oversight and supervision of staff and resources performing pharmaceutical development studies such as method development and validation, stability, QC, etc.  

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.  

Summarized Purpose:

Provides oversight and supervision of staff and resources performing pharmaceutical development studies such as method development and validation, stability, QC, etc. Manages the work activities of group and associate group leaders, resource planning and allocation, client communication, technical document generation and review, mentoring technical staff and troubleshooting method and product-related issues. Ensures the compliance of work performed within the laboratory as well as working with manager to meet the financial goals of the organization.

Essential Functions:  

Reviews and approves study protocols, project status reports, final study reports and other project related technical documents. Designs experimental studies and participates in technical troubleshooting. Allocates, schedules and manages laboratory resources for group's project activities and updates project status and revenue projections. Reviews timesheet reports for billing accuracy. Reviews data for technical quality and compliance to protocols, methods and SOPs. Approves laboratory investigations, deviations, QA facility and data audits. Leads client and FDA audits. Responds to clients questions and needs; leads client technical meetings. Provides recommendations to clients on analytical and compliance issues. Prepares and approves proposals, project definition and pricing. Participates in project definition and negotiations with client on timelines and budget. Identifies business opportunities at conferences, workshops, within the community, through client interaction, etc. Participates in technical sales and marketing; prepares technical marketing materials. Works with business development as technical representative for client visits/discussions. Prepares and implements PPD SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvements. Accountable for group's knowledge and application of good practices pertaining to GMP/GLP and / or other laboratory / client requirements. Participates in bi-annual SOP review & change. Ownership of changes needed to comply with SOPs. Regularly communicates to staff quality related issues and items for staff development and implements quality improvements.

#LI-33456501_TG1

Education and Experience:  

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years) or equivalent and relevant combination of education, training, & experience.

2 years of management responsibility

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:  

Ability to train and mentor junior staff Ability to cultivate a collaborative work environment with a team and across business areas Effective written and oral communication skills as well as presentation skills Proven problem solving and troubleshooting abilities Understanding of basic financial terms and definitions as it applies to the business Ability to independently develop project proposals/plans Project and time management skills Proven ability to identify and implement common efficiencies across multiple programs/projects Demonstrated understanding of the bid process and can utilize expertise of others to develop programs to meet unique client needs Proven ability to cope with a dynamic work environment Working Environment:  

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role: 

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. 

Able to work upright and stationary and/or standing for typical working hours.  

Able to lift and move objects up to 25 pounds  

Able to work in non-traditional work environments.  

Able to use and learn standard office equipment and technology with proficiency.  

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. 

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. 

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD - 

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

Education and Experience:  

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years) or equivalent and relevant combination of education, training, & experience.

2 years of management responsibility

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:  

Ability to train and mentor junior staff Ability to cultivate a collaborative work environment with a team and across business areas Effective written and oral communication skills as well as presentation skills Proven problem solving and troubleshooting abilities Understanding of basic financial terms and definitions as it applies to the business Ability to independently develop project proposals/plans Project and time management skills Proven ability to identify and implement common efficiencies across multiple programs/projects Demonstrated understanding of the bid process and can utilize expertise of others to develop programs to meet unique client needs Proven ability to cope with a dynamic work environment Working Environment:  

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role: 

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. 

Able to work upright and stationary and/or standing for typical working hours.  

Able to lift and move objects up to 25 pounds  

Able to work in non-traditional work environments.  

Able to use and learn standard office equipment and technology with proficiency.  

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. 

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. 

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD - 

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

Submission for the position: Senior Group Leader - Lab Supervisor, Biopharmaceutical Testing - (Job Number: 171627)


2020-06-23 00:00:00


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