Senior Scientist - Quality Control - HPLC - Dissolution - GMP

Submission for the position: Senior Scientist - Quality Control - HPLC - Dissolution - GMP - (Job Number: 173320)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 a Senior Scientist you will partner with cross-functional teams to continue building a Quality Control organization with primary focus on compliance and efficiency, in order to provide first-in-class service to external and internal customers. This candidate with manage critical, commercial laboratory systems and be compliance subject matter expert in a growing organization.

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

Partner with Corporate Compliance, Quality Assurance, Global Information Services, and Operations-Facilities in execution of QC functionsReview of technical and compliant cGMP analytical dataWriting technical methods and reportsAnalysis of cGMP samples utilizing various analytical techniques-HPLC, dissolution, GC, KF, etc., including method validation, method transfer, and stabilityReview of cGMP equipment and software qualifications and repairAt 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!

What To Expect Next

We look forward to receiving your application. A member of our talent acquisition department will review your qualifications and if interested, you will be contacted for an interview.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 a Senior Scientist you will partner with cross-functional teams to continue building a Quality Control organization with primary focus on compliance and efficiency, in order to provide first-in-class service to external and internal customers. This candidate with manage critical, commercial laboratory systems and be compliance subject matter expert in a growing organization.

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

Partner with Corporate Compliance, Quality Assurance, Global Information Services, and Operations-Facilities in execution of QC functionsReview of technical and compliant cGMP analytical dataWriting technical methods and reportsAnalysis of cGMP samples utilizing various analytical techniques-HPLC, dissolution, GC, KF, etc., including method validation, method transfer, and stabilityReview of cGMP equipment and software qualifications and repairAt 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!

What To Expect Next

We look forward to receiving your application. A member of our talent acquisition department will review your qualifications and if interested, you will be contacted for an interview.

Education and Experience:Bachelor's degree/Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years’) or equivalent combination of education, training, & experience. OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2 year)

Knowledge, Skills and Abilities: Demonstrated knowledge of multiple analytical techniques in a QC/commercial setting such as: HPLC, GC, MS, Dissolution Testing, Karl Fischer, UV-Vis, FT-IRDemonstrated knowledge with both drug substance and drug product (oral solid dosage forms) testingProficient with electronic notebooks and computerized Quality Management SystemsKnowledge of Empower Software and Statistical software (JMP, Matlab, Minitab)Proficient in Microsoft Excel and WordProven ability to interpret data by performing trend analysisProven ability in technical writing skillsAbility to independently optimize analytical methodsProven problem solving and troubleshooting abilitiesGood written and oral communication skillsTime management and project management skillsAbility to work in a collaborative work environment with a teamWorking 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.

key words: "scientific writing" , JMP, dissolution, "method development", "method validation", CMC, GMP

*LI-NW1

Education and Experience:Bachelor's degree/Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years’) or equivalent combination of education, training, & experience. OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2 year)

Knowledge, Skills and Abilities: Demonstrated knowledge of multiple analytical techniques in a QC/commercial setting such as: HPLC, GC, MS, Dissolution Testing, Karl Fischer, UV-Vis, FT-IRDemonstrated knowledge with both drug substance and drug product (oral solid dosage forms) testingProficient with electronic notebooks and computerized Quality Management SystemsKnowledge of Empower Software and Statistical software (JMP, Matlab, Minitab)Proficient in Microsoft Excel and WordProven ability to interpret data by performing trend analysisProven ability in technical writing skillsAbility to independently optimize analytical methodsProven problem solving and troubleshooting abilitiesGood written and oral communication skillsTime management and project management skillsAbility to work in a collaborative work environment with a teamWorking 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.

key words: "scientific writing" , JMP, dissolution, "method development", "method validation", CMC, GMP

*LI-NW1

Submission for the position: Senior Scientist - Quality Control - HPLC - Dissolution - GMP - (Job Number: 173320)