Senior Lab Support Tech - Sample Aliquoting

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.

Summarized Purpose:

- Maintain oversight of Biopharm critical reagents, reference standards to and from various R&D departments, client

commercial manufacturing organizations or contract manufacturing testing labs.

- Support and manage as required the method life cycles associated with Control Standards, apply appropriate statistical

tools to asses Control Standards capability, and develop method qualification/validation strategies consistent with ICH

requirements and current regulatory expectations.

- Administer the critical reagents/reference standard inventory program and support the effective transfer to and from

sites.

- Assume responsibility for writing and reviewing SOPs, protocols, and laboratory documentation as necessary.

- Work closely within and across interdepartmental matrix teams to ensure harmonization of work processes.

- Work with QA, document control and validation groups to ensure quality standards are maintained and/or enhanced.

- As appropriate, be able to assume delegated duties associated with the Critical Reagents and Emerging Markets Group/

Analytical Tech Transfer and Supply.

- 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.

- Leads major sample events, coordinates all aspects and directs Sample Management and laboratory staff.

- Deciphers complex protocols and assures the validity of sample requests enforcing SOP as necessary.

Essential Functions and Other Job Information:

- Oversees and independently performs a variety of complex sample and standard tasks (receipt, check-in, login, labeling,

launching, inventory, transport, check- out, return, disposals, etc.) in support of the laboratory.

- Guides and advises laboratory staff in sample / standard procedures as well as being able to create samples in the electronic system.

- Communicates status of sample / standard tasks to laboratory. and aliquotes samples and reconstitute samples

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

- Reviews and provides feedback on laboratory requests, ensuring compliance with applicable SOPs. Able to read and understand protocols.

- Assists in preparation and implementation of SOPs and quality systems.

- Responds to environmental unit alarms and participates in on-call responsibilities.

- Performs work assignments accurately and in a timely and safe manner

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.

*LI-NW1PPD 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.

Summarized Purpose:

- Maintain oversight of Biopharm critical reagents, reference standards to and from various R&D departments, client

commercial manufacturing organizations or contract manufacturing testing labs.

- Support and manage as required the method life cycles associated with Control Standards, apply appropriate statistical

tools to asses Control Standards capability, and develop method qualification/validation strategies consistent with ICH

requirements and current regulatory expectations.

- Administer the critical reagents/reference standard inventory program and support the effective transfer to and from

sites.

- Assume responsibility for writing and reviewing SOPs, protocols, and laboratory documentation as necessary.

- Work closely within and across interdepartmental matrix teams to ensure harmonization of work processes.

- Work with QA, document control and validation groups to ensure quality standards are maintained and/or enhanced.

- As appropriate, be able to assume delegated duties associated with the Critical Reagents and Emerging Markets Group/

Analytical Tech Transfer and Supply.

- 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.

- Leads major sample events, coordinates all aspects and directs Sample Management and laboratory staff.

- Deciphers complex protocols and assures the validity of sample requests enforcing SOP as necessary.

Essential Functions and Other Job Information:

- Oversees and independently performs a variety of complex sample and standard tasks (receipt, check-in, login, labeling,

launching, inventory, transport, check- out, return, disposals, etc.) in support of the laboratory.

- Guides and advises laboratory staff in sample / standard procedures as well as being able to create samples in the electronic system.

- Communicates status of sample / standard tasks to laboratory. and aliquotes samples and reconstitute samples

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

- Reviews and provides feedback on laboratory requests, ensuring compliance with applicable SOPs. Able to read and understand protocols.

- Assists in preparation and implementation of SOPs and quality systems.

- Responds to environmental unit alarms and participates in on-call responsibilities.

- Performs work assignments accurately and in a timely and safe manner

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.

*LI-NW1Qualifications:

Education & Experience

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification

- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).

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:

- Knowledge of inventory flow and control

- Knowledge of laboratory and regulatory requirements (documentation, sample storage) as well as experience in aliquoting samples

- Ability to understand and independently apply appropriate laboratory standards to everyday work with regard to

documentation and sample / standard handling and experience in reading and understanding protocols

- Familiarity with Microsoft Office including Word and Excel

- Good written and oral communication skills

- Effective time management and project management skills

- Problem solving/troubleshooting abilities

- Ability to work in a collaborative team environment

Preferred Experience & Education:

- GMP Knowledge

-- Bachelor’s degree in biochemistry or analytical chemistry plus a minimum of 2 years’ experience in thebiopharmaceutical industry

- Candidate must have a working knowledge in a biopharmaceutical quality control or development laboratoryenvironment.

- Experience with method qualification, validation, technology transfer, and stability testing.

- Cold Chain distribution, inventory management, and other logistical experience are highly desirable.

- Familiar with statistical trending.

- Project Management skills.

- Strong familiarity with FDA/EU/ICH and ROW regulations and guidance.

- Microsoft Windows experience required, with technical proficiency in Word, Excel, Empower, LIMS, and other laboratory

IT systems typically used in the industry

- Excellent written and verbal communication skills, ability to interact with both internal and external parties

- Ability to work both independently and within a 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 including infectious agents, typically found in healthcare or

laboratory environments.

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

Education & Experience

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification

- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).

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:

- Knowledge of inventory flow and control

- Knowledge of laboratory and regulatory requirements (documentation, sample storage) as well as experience in aliquoting samples

- Ability to understand and independently apply appropriate laboratory standards to everyday work with regard to

documentation and sample / standard handling and experience in reading and understanding protocols

- Familiarity with Microsoft Office including Word and Excel

- Good written and oral communication skills

- Effective time management and project management skills

- Problem solving/troubleshooting abilities

- Ability to work in a collaborative team environment

Preferred Experience & Education:

- GMP Knowledge

-- Bachelor’s degree in biochemistry or analytical chemistry plus a minimum of 2 years’ experience in thebiopharmaceutical industry

- Candidate must have a working knowledge in a biopharmaceutical quality control or development laboratoryenvironment.

- Experience with method qualification, validation, technology transfer, and stability testing.

- Cold Chain distribution, inventory management, and other logistical experience are highly desirable.

- Familiar with statistical trending.

- Project Management skills.

- Strong familiarity with FDA/EU/ICH and ROW regulations and guidance.

- Microsoft Windows experience required, with technical proficiency in Word, Excel, Empower, LIMS, and other laboratory

IT systems typically used in the industry

- Excellent written and verbal communication skills, ability to interact with both internal and external parties

- Ability to work both independently and within a 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 including infectious agents, typically found in healthcare or

laboratory environments.

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