Senior Scientist - Biologics Protein Separation, GxP

Submission for the position: Senior Scientist - Biologics Protein Separation, GxP - (Job Number: 173696)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.

Versatile, biologics development GxP laboratory seeks a hard-working, results-focused Research & Development (R&D) scientist with experience in protein analysis to bring a world-class R&D Biologics portfolio to market. The senior scientist position will be located at a Client site in New Brunswick, NJ within the Biologics GxP - Bioseparations Laboratory.

DUTIES & RESPONSIBILITIES:

Essential Duties and Responsibilities include, but are not limited to, the following:

Independently perform biologics separation assays on monoclonal antibodies, fusion proteins, antibody-drug conjugates (ADCs) and fixed drug ratio combination (FDRC) products to support clinical development of therapies, particularly against immuno-oncology (IO) and oncology diseases.Execute electrophoretic-based and chromatography-based testing of biologics, including but not limited to CE-SDS, iCIEF, SE-HPLC, RP-HPLC, CEX, and peptide mapping analyses, as necessary, to support Research & Development (e.g. clinical release and stability, reference material qualification, and product development).Demonstrate practical knowledge of analytical techniques to contribute to development of phase-appropriate, robust and reproducible analytical methods for use in the GMP clinical laboratory.Independently execute analytical method qualification/validation (as applicable) and transfer to external QC laboratories. Carefully adhere to approved protocols, as applicable.Perform duties in full compliance of relevant Good Laboratory Practice (GLP) or Good manufacturing Practice (GMP) regulations, corporate policies and site procedures.Author clear, complete analytical methods and technical reports. Review technical documents, reports and protocols to assure technical merit, accuracy and completeness.Proactively provide clear, timely communication of potential issues to management.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.

Versatile, biologics development GxP laboratory seeks a hard-working, results-focused Research & Development (R&D) scientist with experience in protein analysis to bring a world-class R&D Biologics portfolio to market. The senior scientist position will be located at a Client site in New Brunswick, NJ within the Biologics GxP - Bioseparations Laboratory.

DUTIES & RESPONSIBILITIES:

Essential Duties and Responsibilities include, but are not limited to, the following:

Independently perform biologics separation assays on monoclonal antibodies, fusion proteins, antibody-drug conjugates (ADCs) and fixed drug ratio combination (FDRC) products to support clinical development of therapies, particularly against immuno-oncology (IO) and oncology diseases.Execute electrophoretic-based and chromatography-based testing of biologics, including but not limited to CE-SDS, iCIEF, SE-HPLC, RP-HPLC, CEX, and peptide mapping analyses, as necessary, to support Research & Development (e.g. clinical release and stability, reference material qualification, and product development).Demonstrate practical knowledge of analytical techniques to contribute to development of phase-appropriate, robust and reproducible analytical methods for use in the GMP clinical laboratory.Independently execute analytical method qualification/validation (as applicable) and transfer to external QC laboratories. Carefully adhere to approved protocols, as applicable.Perform duties in full compliance of relevant Good Laboratory Practice (GLP) or Good manufacturing Practice (GMP) regulations, corporate policies and site procedures.Author clear, complete analytical methods and technical reports. Review technical documents, reports and protocols to assure technical merit, accuracy and completeness.Proactively provide clear, timely communication of potential issues to management.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 4 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:  

At least one year of cGMP experience in a regulated lab is required.

GMP laboratory experience is preferred.

Experience with analysis of proteins in Research & Development environment is essential.

The candidate must have good written communication skills. Must be able to independently author and review analytical methods, qualification/validation protocols and technical reports.

Ability to identify, communicate and remediate technical issues pertaining to protein separation analytics is crucial. Skill in communicating/escalating critical issues to appropriate management is necessary.

Understanding of cGMP/GLP and GDPs practices and EHS requirements is essential. Ability to comply with all applicable SOPs, internal requirements and external regulations is a must. Must have at least 1 year of experience in GMP environment.

Expertise using Empower, Electronic Laboratory Notebook (e.g. Velquest, Symyx), Laboratory Information Systems (LIMS) and MS Office applications, in particular MS Word and Excel, is preferred. Familiarity with electronic documentation systems (e.g. Syncade-DCA) for routing protocols/reports for review and approval is a plus.

Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidanceAbility to utilize Microsoft Excel and Word to perform tasksProficiency on technical operating systemsProven problem solving and troubleshooting abilitiesEffective oral and written communication skillsProven ability in technical writing skillsTime management and project management skillsAbility to work in a collaborative work environment with a teamProven problem solving and troubleshooting abilitiesAbility to train junior staffWorking 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 4 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:  

At least one year of cGMP experience in a regulated lab is required.

GMP laboratory experience is preferred.

Experience with analysis of proteins in Research & Development environment is essential.

The candidate must have good written communication skills. Must be able to independently author and review analytical methods, qualification/validation protocols and technical reports.

Ability to identify, communicate and remediate technical issues pertaining to protein separation analytics is crucial. Skill in communicating/escalating critical issues to appropriate management is necessary.

Understanding of cGMP/GLP and GDPs practices and EHS requirements is essential. Ability to comply with all applicable SOPs, internal requirements and external regulations is a must. Must have at least 1 year of experience in GMP environment.

Expertise using Empower, Electronic Laboratory Notebook (e.g. Velquest, Symyx), Laboratory Information Systems (LIMS) and MS Office applications, in particular MS Word and Excel, is preferred. Familiarity with electronic documentation systems (e.g. Syncade-DCA) for routing protocols/reports for review and approval is a plus.

Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidanceAbility to utilize Microsoft Excel and Word to perform tasksProficiency on technical operating systemsProven problem solving and troubleshooting abilitiesEffective oral and written communication skillsProven ability in technical writing skillsTime management and project management skillsAbility to work in a collaborative work environment with a teamProven problem solving and troubleshooting abilitiesAbility to train junior staffWorking 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: Senior Scientist - Biologics Protein Separation, GxP - (Job Number: 173696)