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Sample Management Technical Lead

Pharmaceutical Product Development (PPD)

US-WI-Middleton-Middleton WI Research Way

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.

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:

Leads and coordinates major sample events, directing sample management and laboratory staff in a functional area. Deciphers complex protocols and ensures the validity of sample requests and adherence to secure and robust sample handling processes in a dynamic environment. Supports risk assessment and design of sample handling practices.

Essential Functions:

Acts as a technical liaison to the lab and clients for project-specific sample-management procedures by reviewing and approving changes to studies and storage of material. Selects appropriate packaging supplies for storage of materials.

• Performs any function, including, oversight of a variety of detailed tasks including material receipt, accessioning, routing, storage, aliquoting, shipping, discard, destruction, etc.

• Actively assesses the study and material needs of the sample management staff.

• Actively trains, mentors and assesses the needs of the sample management staff.

• Writes new SOP's and performs risk assessment and process design.

• Guides and advises laboratory staff in sample / standard procedures.

• Completes investigation and deviation forms as necessary, and determines appropriate CAPAs.

• Coordinates and performs a variety of complex sample and standard handling tasks in support of all aspects of the laboratory, follows SOPs and industry appropriate laboratory standards.

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.

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:

Leads and coordinates major sample events, directing sample management and laboratory staff in a functional area. Deciphers complex protocols and ensures the validity of sample requests and adherence to secure and robust sample handling processes in a dynamic environment. Supports risk assessment and design of sample handling practices.

Essential Functions:

Acts as a technical liaison to the lab and clients for project-specific sample-management procedures by reviewing and approving changes to studies and storage of material. Selects appropriate packaging supplies for storage of materials.

• Performs any function, including, oversight of a variety of detailed tasks including material receipt, accessioning, routing, storage, aliquoting, shipping, discard, destruction, etc.

• Actively assesses the study and material needs of the sample management staff.

• Actively trains, mentors and assesses the needs of the sample management staff.

• Writes new SOP's and performs risk assessment and process design.

• Guides and advises laboratory staff in sample / standard procedures.

• Completes investigation and deviation forms as necessary, and determines appropriate CAPAs.

• Coordinates and performs a variety of complex sample and standard handling tasks in support of all aspects of the laboratory, follows SOPs and industry appropriate laboratory standards.

Education and Experience:

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Technical positions may require a certificate

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).

Knowledge, Skills and Abilities:

• Solid understanding of GxP

• Proficient with Microsoft Office including Word, Excel and Power Point

• Strong project management skills

• Good leadership abilities

• Strong attention to detail

• Developed problem solving/troubleshooting abilities

• Excellent written and oral communication skills

• Ability to work in a collaborative team 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 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:

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Technical positions may require a certificate

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).

Knowledge, Skills and Abilities:

• Solid understanding of GxP

• Proficient with Microsoft Office including Word, Excel and Power Point

• Strong project management skills

• Good leadership abilities

• Strong attention to detail

• Developed problem solving/troubleshooting abilities

• Excellent written and oral communication skills

• Ability to work in a collaborative team 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 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.

Job posted: 2021-04-14

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