Senior Scientist - Small Molecule HPLC , Quality Control , GMP

Submission for the position: Senior Scientist - Small Molecule HPLC , Quality Control , GMP - (Job Number: 176960)

In labs and health care facilities worldwide-- HERE WE ARE

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.

As aSenior Scientist,you will perform all aspects of chemistry-based laboratory testing in support of the in-process, release and stability testing for a commercial small molecule API parenteral liposome formulation. You will also be a key member and lead in the areas of continuous improvement projects, laboratory investigations, deviations and troubleshooting of aberrant data and equipment malfunctions..

Additional responsibilities for the role on site at a major pharmaceutical company:

Independently perform in-process and routine testing for small molecule API parental drug product and lipid raw materials using a variety of HPLC based and chemistry methods in a GMP lab; HPLC with UV, RI and ELS detections, particle size distribution and zeta potential analysis, in-vitro release assays, pH, osmolality, UV-VisPerform daily calibrations and equipment checks to support daily lab testingExecute all laboratory functions per defined procedures in full compliance GMP standards with close attention to detail and minimal analyst-generated errorsPerform peer technical review of analytical data packages and equipment qualification packagesIdentify and troubleshoot aberrant data and laboratory equipment malfunctionsLead complex investigations, root cause determinations, and instrument failure investigationsMaintain and troubleshoot various pieces of validated lab equipment including HPLCsIdentify laboratory continuous improvement projects and lead implementation initiativesIndependently support various additional quality systems including unplanned events, CAPA and change controlsSupport preparation and revision of SOPs through identification of boundaries and gapsMay train other analysts on chemistry and analytical techniquesMay cross-train on micro-biological lab techniquesMay perform analytical method validations and method transfers for small molecule API formulationsAt PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

Join PPD in our relentless pursuit of excellence - apply now!

In labs and health care facilities worldwide-- HERE WE ARE

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.

As aSenior Scientist,you will perform all aspects of chemistry-based laboratory testing in support of the in-process, release and stability testing for a commercial small molecule API parenteral liposome formulation. You will also be a key member and lead in the areas of continuous improvement projects, laboratory investigations, deviations and troubleshooting of aberrant data and equipment malfunctions..

Additional responsibilities for the role on site at a major pharmaceutical company:

Independently perform in-process and routine testing for small molecule API parental drug product and lipid raw materials using a variety of HPLC based and chemistry methods in a GMP lab; HPLC with UV, RI and ELS detections, particle size distribution and zeta potential analysis, in-vitro release assays, pH, osmolality, UV-VisPerform daily calibrations and equipment checks to support daily lab testingExecute all laboratory functions per defined procedures in full compliance GMP standards with close attention to detail and minimal analyst-generated errorsPerform peer technical review of analytical data packages and equipment qualification packagesIdentify and troubleshoot aberrant data and laboratory equipment malfunctionsLead complex investigations, root cause determinations, and instrument failure investigationsMaintain and troubleshoot various pieces of validated lab equipment including HPLCsIdentify laboratory continuous improvement projects and lead implementation initiativesIndependently support various additional quality systems including unplanned events, CAPA and change controlsSupport preparation and revision of SOPs through identification of boundaries and gapsMay train other analysts on chemistry and analytical techniquesMay cross-train on micro-biological lab techniquesMay perform analytical method validations and method transfers for small molecule API formulationsAt PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

Join PPD in our relentless pursuit of excellence - apply now!

Education and Experience:  

Bachelor's degree in Chemistry, Analytical Chemistry, Biology 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 industry experience).

Preferred Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 6 years pharmaceutical experience in a QC or related lab testing function

In-depth knowledge and first-hand experience with most or all the following techniques: Reversed-Phase HPLC, HPLC with ELSD detection, HPLC with RI detection, dissolution and in-vitro release assays, particle size, zeta potential, pH, osmolality and other standard wet chemistry methods

Experience in a GMP compliant laboratory strongly preferred

Experience with HPLC ELS detection highly desirable

Working experience with Waters Empower3 chromatography software strongly preferred

Knowledge, Skills and Abilities:

Demonstrated knowledge of multiple applicable techniques such as: Reversed-Phase HPLC, HPLC with ELSD detection, HPLC with RI detection, dissolution and in-vitro release assays, particle size, zeta potential, pH, osmolality and other standard wet chemistry methods

Expertise in GMP documentation and pharmaceutical quality systems 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 independently with minimal supervision as well as 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.  A ble 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.    

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. 

keywords: QC, GMP , HPLC , "quality control" , "small molecule"

*LI-NW1

Education and Experience:  

Bachelor's degree in Chemistry, Analytical Chemistry, Biology 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 industry experience).

Preferred Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 6 years pharmaceutical experience in a QC or related lab testing function

In-depth knowledge and first-hand experience with most or all the following techniques: Reversed-Phase HPLC, HPLC with ELSD detection, HPLC with RI detection, dissolution and in-vitro release assays, particle size, zeta potential, pH, osmolality and other standard wet chemistry methods

Experience in a GMP compliant laboratory strongly preferred

Experience with HPLC ELS detection highly desirable

Working experience with Waters Empower3 chromatography software strongly preferred

Knowledge, Skills and Abilities:

Demonstrated knowledge of multiple applicable techniques such as: Reversed-Phase HPLC, HPLC with ELSD detection, HPLC with RI detection, dissolution and in-vitro release assays, particle size, zeta potential, pH, osmolality and other standard wet chemistry methods

Expertise in GMP documentation and pharmaceutical quality systems 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 independently with minimal supervision as well as 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.  A ble 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.    

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. 

keywords: QC, GMP , HPLC , "quality control" , "small molecule"

*LI-NW1 Submission for the position: Senior Scientist - Small Molecule HPLC , Quality Control , GMP - (Job Number: 176960)