Research Scientist - Bioassay - Method Development GMP

Submission for the position: Research Scientist - Bioassay - Method Development GMP - (Job Number: 179761)

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.

In this position you will be responsible for development and qualification of analytical methods in support of hematopoietic stem cell gene therapies.

You shouldhave a strong passion and curiosity for science and gene therapy with the desire to bring needed cures from bench to bedside. Demonstrated genuine interest and curiosity in research and analytical development is highly valued.

Primary Responsibilities

• Develop and qualify biophysical analytical methods for characterizing impurities in cell therapy product.

• Design and execute experiments and maintain appropriate consumable inventories to support method development.

• Perform routine testing of samples for characterization and release. This includes HPLC/UPLC, LC/MS, DLS, ELISA, etc.

• Support daily operations by maintaining and qualifying controls and critical reagents.

• Be responsible for the execution, data review, analysis and document writing.

• Maintain accurate and detailed laboratory notebooks in a timely fashion and prepare technical reports, summaries, protocols.

• Collaborate with others to handle day to day operation of the laboratory to ensure smooth operation.

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

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.

In this position you will be responsible for development and qualification of analytical methods in support of hematopoietic stem cell gene therapies.

You shouldhave a strong passion and curiosity for science and gene therapy with the desire to bring needed cures from bench to bedside. Demonstrated genuine interest and curiosity in research and analytical development is highly valued.

Primary Responsibilities

• Develop and qualify biophysical analytical methods for characterizing impurities in cell therapy product.

• Design and execute experiments and maintain appropriate consumable inventories to support method development.

• Perform routine testing of samples for characterization and release. This includes HPLC/UPLC, LC/MS, DLS, ELISA, etc.

• Support daily operations by maintaining and qualifying controls and critical reagents.

• Be responsible for the execution, data review, analysis and document writing.

• Maintain accurate and detailed laboratory notebooks in a timely fashion and prepare technical reports, summaries, protocols.

• Collaborate with others to handle day to day operation of the laboratory to ensure smooth operation.

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'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 8 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 method development experience in impurity profiling using biophysical and analytical chemical methods Experience in a GMP regulated Lab is strongly desired. Experienced in development, optimization, and validation of biophysical and biochemical methods in a GLP or GMP environment. Extensive hands-on experience with HPLC/UPLC, LC-MS, DLS and Zetasizer Hands-on experience in ELISAs, Western blotting and other protein-based technique. Experience qualifying, validating and transferring analytical methods to a QC lab setting. Proven track record in method development, including experimental design, execution and evaluation. Strong understanding of GMP and ICH guidelines. Ability to work in a fast-paced environment, meet deadlines, and prioritize work on multiple projects. Strong communication skills in technical writing and oral presentation. Ability to carefully follow existing methods and SOPs. Ability to maintain meticulous records and documentation. Strong sense of responsibility, accountability, and integrity. Strong problem-solving and troubleshooting skills. Strong capabilities in experimental design and execution. Ability to work independently Familiar with USP and other compendia Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance Ability to independently optimize analytical methods Ability to independently perform root cause analysis for method investigations Proven technical writing skills Effective written and oral communication skills as well as presentation skills Time management and project management skills Ability to mentor others on technical operating systems Ability to independently review and understand project proposals/plans Ability to work in a collaborative work environment with a team

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. 

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 8 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 method development experience in impurity profiling using biophysical and analytical chemical methods Experience in a GMP regulated Lab is strongly desired. Experienced in development, optimization, and validation of biophysical and biochemical methods in a GLP or GMP environment. Extensive hands-on experience with HPLC/UPLC, LC-MS, DLS and Zetasizer Hands-on experience in ELISAs, Western blotting and other protein-based technique. Experience qualifying, validating and transferring analytical methods to a QC lab setting. Proven track record in method development, including experimental design, execution and evaluation. Strong understanding of GMP and ICH guidelines. Ability to work in a fast-paced environment, meet deadlines, and prioritize work on multiple projects. Strong communication skills in technical writing and oral presentation. Ability to carefully follow existing methods and SOPs. Ability to maintain meticulous records and documentation. Strong sense of responsibility, accountability, and integrity. Strong problem-solving and troubleshooting skills. Strong capabilities in experimental design and execution. Ability to work independently Familiar with USP and other compendia Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance Ability to independently optimize analytical methods Ability to independently perform root cause analysis for method investigations Proven technical writing skills Effective written and oral communication skills as well as presentation skills Time management and project management skills Ability to mentor others on technical operating systems Ability to independently review and understand project proposals/plans Ability to work in a collaborative work environment with a team

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. 

Submission for the position: Research Scientist - Bioassay - Method Development GMP - (Job Number: 179761)