Associate Group Leader or Group Leader - Biopharm

Submission for the position: Associate Group Leader or Group Leader - Biopharm - (Job Number: 186147)

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

As an Associate Group Leader, provide line-level management coordination of resources and work schedules for laboratory activities.

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 line-level management coordination of resources and work schedules for laboratory activities. Oversees daily operations and assists in preparation and implementation of company policies, quality systems and training programs. Ensures that projects are completed in a timely manner so that company revenues are met and clients are satisfied with the quality and turnaround time of work being performed. Ensures that laboratory staff continues to be developed to keep pace with department goals and growth. This position will also be working part of the time in the lab using HPLC, ELISA, c-IEF in a GLP lab setting.

Essential Functions:   Performs lab work in accordance with client protocols, methods and requirements. HPLC, ELISA, c-IEF in a GLP lab setting. Prepares study protocols, project status reports, final study reports and other project-related technical documentation. Designs experimental study and participates in technical troubleshooting. Reviews, interprets and analyzes data for technical quality and compliance to protocols, methods and SOPs. Reviews laboratory investigations and deviation. Organizes, schedules and supervises laboratory resources for group's project activities and updates project status. Responds to client questions and needs, coordinates client communication and records meeting minutes. Assists group leaders in their responsibilities. Assists in preparation and implementation of PPD/client SOPs and company operational policies. Ensures adherence to SOPs, safety standards and company policies.

*LI-SW1

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

As an Associate Group Leader, provide line-level management coordination of resources and work schedules for laboratory activities.

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 line-level management coordination of resources and work schedules for laboratory activities. Oversees daily operations and assists in preparation and implementation of company policies, quality systems and training programs. Ensures that projects are completed in a timely manner so that company revenues are met and clients are satisfied with the quality and turnaround time of work being performed. Ensures that laboratory staff continues to be developed to keep pace with department goals and growth. This position will also be working part of the time in the lab using HPLC, ELISA, c-IEF in a GLP lab setting.

Essential Functions:   Performs lab work in accordance with client protocols, methods and requirements. HPLC, ELISA, c-IEF in a GLP lab setting. Prepares study protocols, project status reports, final study reports and other project-related technical documentation. Designs experimental study and participates in technical troubleshooting. Reviews, interprets and analyzes data for technical quality and compliance to protocols, methods and SOPs. Reviews laboratory investigations and deviation. Organizes, schedules and supervises laboratory resources for group's project activities and updates project status. Responds to client questions and needs, coordinates client communication and records meeting minutes. Assists group leaders in their responsibilities. Assists in preparation and implementation of PPD/client SOPs and company operational policies. Ensures adherence to SOPs, safety standards and company policies.

*LI-SW1 Education and Experience:  Bachelor Degree in Chemistry, Organic Chemistry, Chemical Engineering, Forensics, or similar Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years) or equivalent and relevant combination of education, training, & experience. 1 year of leadership 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: Demonstrated proficiency on technical operating systems At least one year of experience in a Regulated GLP Lab is required. Demonstrated abiltity to performlab work forHPLC, ELISA, cIEF , etc. in a GLP Lab setting. Proven leadership skills Ability to train and mentor junior staff Demonstrated ability to be project solution driven Good written and oral communication skills as well as presentation skills Can independently perform root cause analysis for method investigations Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.) Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs Ability to independently optimize analytical methods Project and time management skills 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:  Bachelor Degree in Chemistry, Organic Chemistry, Chemical Engineering, Forensics, or similar Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years) or equivalent and relevant combination of education, training, & experience. 1 year of leadership 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: Demonstrated proficiency on technical operating systems At least one year of experience in a Regulated GLP Lab is required. Demonstrated abiltity to performlab work forHPLC, ELISA, cIEF , etc. in a GLP Lab setting. Proven leadership skills Ability to train and mentor junior staff Demonstrated ability to be project solution driven Good written and oral communication skills as well as presentation skills Can independently perform root cause analysis for method investigations Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.) Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs Ability to independently optimize analytical methods Project and time management skills 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: Associate Group Leader or Group Leader - Biopharm - (Job Number: 186147)