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- Scientist - HPLC , Dissolution , Stability , GMP
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Scientist - HPLC , Dissolution , Stability , GMP
Pharmaceutical Product Development (PPD)
US-MA-Boston-FSP Boston MA
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 aScientist,you will provide support for the commercial stability program within the Technical Operations Analytical department onsite at the client location. You will be responsible for supporting commerical stability team, ensuring processes are executed in a compliant and efficient manner, and foster good relationships with internal and external stakeholders. Key responsibilities include: Support the commercial stability program, which encompasses all commercial products/strengths including starting materials, drug substance intermediates, drug substance, drug product intermediates, and drug products. Execute on all stability program sub-processes to ensure compliance and efficiency Effectively communicate with internal and external stakeholders Ensure studies are initiated within project timelines Proactively monitor stability studies to ensure compliance with study protocols, Quality Agreements and Regulatory commitments Perform technical data review and comment resolution internally and with external partners Review OOS/OOE investigations and laboratory deviations Perform data analysis and trending according to industry guidelines Generate and provide stability reports for submission to regulatory authorities Monitor and react to key process performance indicators. Ensure flexibility to accommodate changing timelines and priorities
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.
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 aScientist,you will provide support for the commercial stability program within the Technical Operations Analytical department onsite at the client location. You will be responsible for supporting commerical stability team, ensuring processes are executed in a compliant and efficient manner, and foster good relationships with internal and external stakeholders. Key responsibilities include: Support the commercial stability program, which encompasses all commercial products/strengths including starting materials, drug substance intermediates, drug substance, drug product intermediates, and drug products. Execute on all stability program sub-processes to ensure compliance and efficiency Effectively communicate with internal and external stakeholders Ensure studies are initiated within project timelines Proactively monitor stability studies to ensure compliance with study protocols, Quality Agreements and Regulatory commitments Perform technical data review and comment resolution internally and with external partners Review OOS/OOE investigations and laboratory deviations Perform data analysis and trending according to industry guidelines Generate and provide stability reports for submission to regulatory authorities Monitor and react to key process performance indicators. Ensure flexibility to accommodate changing timelines and priorities
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.
Join PPD in our relentless pursuit of excellence - apply now!
Education and Experience: Bachelor's degree in a scientific field 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: HPLC, GC, MS, Dissolution Testing,Karl Fischer, UV-Vis, FT-IR and applying/interpretation of GMP requirements
Knowledge of commerical stability programs
Knowledge of statistical software and its application to support commerical stability
Knowledge of US and EU cGMP regulations/guidance
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
Ability to prioritize objectives from multiple projects, adher to scheduled timelines while maintaining flexibility and attention to detail
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. M ay 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.
*LI-NW1
Education and Experience: Bachelor's degree in a scientific field 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: HPLC, GC, MS, Dissolution Testing,Karl Fischer, UV-Vis, FT-IR and applying/interpretation of GMP requirements
Knowledge of commerical stability programs
Knowledge of statistical software and its application to support commerical stability
Knowledge of US and EU cGMP regulations/guidance
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
Ability to prioritize objectives from multiple projects, adher to scheduled timelines while maintaining flexibility and attention to detail
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. M ay 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.
*LI-NW1
Job posted: 2021-03-17