Associate Scientist or Scientist - DD-PCR Gene Therapy Cell Based Assay

Submission for the position: Associate Scientist or Scientist - DD-PCR Gene Therapy Cell Based Assay - (Job Number: 179899)

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.

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 well being of our employees.   

Summarized Purpose:

Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis with increased independence. Performs 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. Follows validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. Enters data into databases and reports. Performs self-review for own data prior to QC submission.

Specifics for this position:

• Analytical sciences role supporting Process Development manufacturing for an AAV based Gene Therapy company reporting in to the Manager of Analytical Development.

• Evaluate new gene of interest constructs on currently in-place methods

• Author SOPs, forms, protocols and reports

• Data entry and Review

• Serve as technical SMEs for process investigationsJob Description

• Using DD-PCR and/or Q-PCR (Cell Based Assay with Gene Therapy experience could be helpful)

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.

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 well being of our employees.   

Summarized Purpose:

Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis with increased independence. Performs 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. Follows validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. Enters data into databases and reports. Performs self-review for own data prior to QC submission.

Specifics for this position:

• Analytical sciences role supporting Process Development manufacturing for an AAV based Gene Therapy company reporting in to the Manager of Analytical Development.

• Evaluate new gene of interest constructs on currently in-place methods

• Author SOPs, forms, protocols and reports

• Data entry and Review

• Serve as technical SMEs for process investigationsJob Description

• Using DD-PCR and/or Q-PCR (Cell Based Assay with Gene Therapy experience could be helpful)

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 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:

Demonstrated knowledge of multiple applicable techniques such as: DD-PCR and Q-PCR

Proficient in Microsoft Excel and Word

Protein assays such as ELISA, SDS-PAGE, Western, etc

Cell based assay experience

Experience writing SOPs and creating forms

Familiar working in ERP, LIMS and EQMS systems

Experience in reviewing GMP documentation

Experience with Software such as: SoftMax Pro and Image Lab

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 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:

Demonstrated knowledge of multiple applicable techniques such as: DD-PCR and Q-PCR

Proficient in Microsoft Excel and Word

Protein assays such as ELISA, SDS-PAGE, Western, etc

Cell based assay experience

Experience writing SOPs and creating forms

Familiar working in ERP, LIMS and EQMS systems

Experience in reviewing GMP documentation

Experience with Software such as: SoftMax Pro and Image Lab

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: Associate Scientist or Scientist - DD-PCR Gene Therapy Cell Based Assay - (Job Number: 179899)