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Senior Scientist - Small Molecule , HPLC , Method Development , GMP

Pharmaceutical Product Development (PPD)

MA-Waltham-FSP Waltham MA

Submission for the position: Senior Scientist - Small Molecule , HPLC , Method Development , GMP - (Job Number: 179337)

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 SeniorScientist, you will provide support to the Analytical Development team. You will execute analysis of small molecule drug substance, drug substance intermediates, and drug products (solid oral dosage forms as well as sterile products). You will also focus on cGMP and non-GMP analysis using various analytical methodologies, including:

High performance liquid chromatography (HPLC)Gas chromatography (GC)DissolutionWater content by Karl Fisher Disintegration (KF)Tablet hardnessFriabilityVibrational spectroscopy (e.g. infrared and Raman)Particle size by laser diffractionDifferential scanning calorimetry (DSC)

Additional Responsibilities while work onsite at a major pharmaceutical customer site:Developing and validating methods as per ICH and GMP guidelinesPerforms complex laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation

Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods and protocols applicable to assigned tasks. Designs and executes experiments with minimal supervision.Communicates data and technical issues to the client and responds to client needs and questions.Mentors, trains and coordinates laboratory activities of other team members and assists in troubleshooting instrument and analytical problems.

Assists with quality systems and new equipment.

Laboratory data and notebook review as well as authorship of protocols, reports, and data trending tables / plots will also be integral parts of the job function.

Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.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 wellbeing of our employees.  

To learn how PPD can advance your career, 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 a SeniorScientist, you will provide support to the Analytical Development team. You will execute analysis of small molecule drug substance, drug substance intermediates, and drug products (solid oral dosage forms as well as sterile products). You will also focus on cGMP and non-GMP analysis using various analytical methodologies, including:

High performance liquid chromatography (HPLC)Gas chromatography (GC)DissolutionWater content by Karl Fisher Disintegration (KF)Tablet hardnessFriabilityVibrational spectroscopy (e.g. infrared and Raman)Particle size by laser diffractionDifferential scanning calorimetry (DSC)

Additional Responsibilities while work onsite at a major pharmaceutical customer site:Developing and validating methods as per ICH and GMP guidelinesPerforms complex laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation

Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods and protocols applicable to assigned tasks. Designs and executes experiments with minimal supervision.Communicates data and technical issues to the client and responds to client needs and questions.Mentors, trains and coordinates laboratory activities of other team members and assists in troubleshooting instrument and analytical problems.

Assists with quality systems and new equipment.

Laboratory data and notebook review as well as authorship of protocols, reports, and data trending tables / plots will also be integral parts of the job function.

Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.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 wellbeing of our employees.  

To learn how PPD can advance your career, apply now!

Education and Experience:  

Bachelor's degree in Chemistry, Analytical Chemistry, or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years).Master's degree in Chemistry, Analytical Chemistry, or equivalent and relevant experience that provides the knowledge, skills, and abilities to perform the job comparable to 2 years of experiencePreferred Experience:Master's degree with 2 years of industry related experiencePrevious experience working in a GMP environmentIn 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:  

Solid understanding and knowledge of general chemistry and separation science such as HPLC, GC, dissolution, KFFull understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use required

Ability to independently optimize analytical methods

Ability to utilize Microsoft Excel and Word to perform tasks Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Effective oral and written communication skills Proven ability in technical writing skills Time management and project management skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to train junior staff 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. 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.

"method development" , "analytical chemistry" , "method validation" , HPLC, dissolution, "small molecule" , GMP

*LI-NW1Education and Experience:  

Bachelor's degree in Chemistry, Analytical Chemistry, or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years).Master's degree in Chemistry, Analytical Chemistry, or equivalent and relevant experience that provides the knowledge, skills, and abilities to perform the job comparable to 2 years of experiencePreferred Experience:Master's degree with 2 years of industry related experiencePrevious experience working in a GMP environmentIn 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:  

Solid understanding and knowledge of general chemistry and separation science such as HPLC, GC, dissolution, KFFull understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use required

Ability to independently optimize analytical methods

Ability to utilize Microsoft Excel and Word to perform tasks Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Effective oral and written communication skills Proven ability in technical writing skills Time management and project management skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to train junior staff 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. 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.

"method development" , "analytical chemistry" , "method validation" , HPLC, dissolution, "small molecule" , GMP

*LI-NW1Submission for the position: Senior Scientist - Small Molecule , HPLC , Method Development , GMP - (Job Number: 179337)

Job posted: 2020-11-24

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