Scientist - Microbiology , Container Closure Integrity Test

Submission for the position: Scientist - Microbiology , Container Closure Integrity Test - (Job Number: 173086)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!   

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 a Scientist you will p erform a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices.

In this position you will be responsible for working with stakeholders from development, clinical, commercial, and manufacturing organizations to develop phase appropriate Container Closure Integrity Test (CCIT) methods, as well as other microbiological methods (endotoxin, bioburden). This is a laboratory-based position and includes, but is not limited to, performing testing to assist in the development and validation of CCIT or microbiological methods in support of aseptic manufacturing of clinical drug products, executing assays for technology transfer to commercial sites, and new technology evaluation/implementation. Responsibilities include executing CCI or microbiological methods within the laboratory, supporting device development and manufacturing groups to evaluate and implement rapid, non-destructive technologies to facilitate testing and manufacture of vials, syringes, and devices, and providing data to interdisciplinary development teams in support of product development plans.

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. 

PPDFSP

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!   

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 a Scientist you will p erform a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices.

In this position you will be responsible for working with stakeholders from development, clinical, commercial, and manufacturing organizations to develop phase appropriate Container Closure Integrity Test (CCIT) methods, as well as other microbiological methods (endotoxin, bioburden). This is a laboratory-based position and includes, but is not limited to, performing testing to assist in the development and validation of CCIT or microbiological methods in support of aseptic manufacturing of clinical drug products, executing assays for technology transfer to commercial sites, and new technology evaluation/implementation. Responsibilities include executing CCI or microbiological methods within the laboratory, supporting device development and manufacturing groups to evaluate and implement rapid, non-destructive technologies to facilitate testing and manufacture of vials, syringes, and devices, and providing data to interdisciplinary development teams in support of product development plans.

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. 

PPDFSP

Education and Experience:  

Bachelor's degreein Microbiology, Biological Sciences, Chemistry, or related scientific discipline 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:

Demonstrated experience in analysis of pharmaceuticals, including microbiological, analytical, or CCI methods.

1 year of GMP experience in a regulated lab is required.

Proficient in Microsoft Excel and Word

Proven ability to interpret data by performing trend analysis

Proven ability in technical writing skills

Ability to independently optimize analytical methods

Proven problem solving and troubleshooting abilities

Good written and oral communication skills

Time management and project management skills

Ability to work in a collaborative work environment with a team

Working Environment:  

PPD values the health and well being 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.    

Education and Experience:  

Bachelor's degreein Microbiology, Biological Sciences, Chemistry, or related scientific discipline 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:

Demonstrated experience in analysis of pharmaceuticals, including microbiological, analytical, or CCI methods.

1 year of GMP experience in a regulated lab is required.

Proficient in Microsoft Excel and Word

Proven ability to interpret data by performing trend analysis

Proven ability in technical writing skills

Ability to independently optimize analytical methods

Proven problem solving and troubleshooting abilities

Good written and oral communication skills

Time management and project management skills

Ability to work in a collaborative work environment with a team

Working Environment:  

PPD values the health and well being 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.    

Submission for the position: Scientist - Microbiology , Container Closure Integrity Test - (Job Number: 173086)