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Senior Scientist - Separation Methods - Biologics - HPLC

Pharmaceutical Product Development (PPD)

US-MA-Devens-FSP Devens MA

Submission for the position: Senior Scientist - Separation Methods - Biologics - HPLC - (Job Number: 189142)

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 join the client's Method Lifecycle Group in the Global Quality Analytical Sciences and Technology (GQAS&T)Department to provide hands-on experience of separations and general compendial methods who support the lifecycle management of methods including transfer, validation, method performance monitoring and analytical troubleshooting.

You will execute methods including but not limited to: SDS-PAGE, CE-SDS, icIEF, ion exchange, size exclusion, and RP HPLC.You will plan & execute experiments as well as analyze data generated at other sites for method troubleshooting and improvements.

You will also support the technology validation and transfer process for late stage and marketed biologic products while ensuring compliance with cGMP requirements and global regulations as part of the team.

Additional responsibilities for the role on site at a major biopharmaceutical company: Perform routine and non-routine analytical testing/experiments according to approved procedures/protocols Provide technical input into analytical method revisions and improvements. Support periodic review of method performance and work with team leader to execute remediation experiments and help implement changes to existing commercial methods Support method transfers to QC/GMP labs within and outside of customer including preparation/review of documentation (e.g. protocols, reports, master plans, and technical reports) to support method validation and/or transfer Perform data review and verifications activities Assist in maintaining/qualification of critical reagent supply for assigned methods Assist in authoring and review sections of regulatory filings as well as in responding to Health Authority queries regarding analytical methods. Participate in GQAS&Tteam goals to achieve safe and collective work environment.

At 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 a Senior Scientist ,you will join the client's Method Lifecycle Group in the Global Quality Analytical Sciences and Technology (GQAS&T)Department to provide hands-on experience of separations and general compendial methods who support the lifecycle management of methods including transfer, validation, method performance monitoring and analytical troubleshooting.

You will execute methods including but not limited to: SDS-PAGE, CE-SDS, icIEF, ion exchange, size exclusion, and RP HPLC.You will plan & execute experiments as well as analyze data generated at other sites for method troubleshooting and improvements.

You will also support the technology validation and transfer process for late stage and marketed biologic products while ensuring compliance with cGMP requirements and global regulations as part of the team.

Additional responsibilities for the role on site at a major biopharmaceutical company: Perform routine and non-routine analytical testing/experiments according to approved procedures/protocols Provide technical input into analytical method revisions and improvements. Support periodic review of method performance and work with team leader to execute remediation experiments and help implement changes to existing commercial methods Support method transfers to QC/GMP labs within and outside of customer including preparation/review of documentation (e.g. protocols, reports, master plans, and technical reports) to support method validation and/or transfer Perform data review and verifications activities Assist in maintaining/qualification of critical reagent supply for assigned methods Assist in authoring and review sections of regulatory filings as well as in responding to Health Authority queries regarding analytical methods. Participate in GQAS&Tteam goals to achieve safe and collective work environment.

At 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, or 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 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)

OR PhD Preferred Experience: Experience working with Empower, SAS, and/or JMP preferred Hands-on experience with HPLC, UPLC, capillary electrophoresis

Knowledge, Skills and Abilities: Familiarity of general compendial methods such as pH, appearance, osmolality, and characterization methods such as chormatography, peptide map is desired Demonstrated troubleshooting abilities and hands-on experience with one or more protein separation methods, including Electrophoresis, Chromatography, and UVIS spectroscopy based technologies (for example SDS-PAGE, CE-SDS, icIEF, different modes of LC) Familiarity with Pharmacopeia requirements/ICH guidelines and GxP applicable to analytical laboratories Understanding of ICH and pharmacopeia for validations Ability to perform work in accordance with GMP requirements Ability to critically evaluate and analyze technical information presented in documents for adherence to written procedures Demonstrated knowledge of the biological drug development process and basic concepts of cGMP Practical knowledge of Empower, SAS, and/or JMP. Proven ability to interpret data by performing trend analysis Proven ability in technical writing skills Proven problem solving, decision-making skills,and troubleshooting abilities Good written and oral communication skills Ability to work in a collaborative to meet shared objectives in a dynamic and matrix team environment Proven ability to multi-task, be detail oriented, conscientious, motivated, flexible and ability to handle multiple projects

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 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: biologics, "separation chemistry" , "separation methods", "HPLC" , "UPLC" , Empower , "analytical chemistry" , protein

*LI-NW1

Education and Experience: Bachelor's degree in Chemistry, Analytical Chemistry, or 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 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)

OR PhD Preferred Experience: Experience working with Empower, SAS, and/or JMP preferred Hands-on experience with HPLC, UPLC, capillary electrophoresis

Knowledge, Skills and Abilities: Familiarity of general compendial methods such as pH, appearance, osmolality, and characterization methods such as chormatography, peptide map is desired Demonstrated troubleshooting abilities and hands-on experience with one or more protein separation methods, including Electrophoresis, Chromatography, and UVIS spectroscopy based technologies (for example SDS-PAGE, CE-SDS, icIEF, different modes of LC) Familiarity with Pharmacopeia requirements/ICH guidelines and GxP applicable to analytical laboratories Understanding of ICH and pharmacopeia for validations Ability to perform work in accordance with GMP requirements Ability to critically evaluate and analyze technical information presented in documents for adherence to written procedures Demonstrated knowledge of the biological drug development process and basic concepts of cGMP Practical knowledge of Empower, SAS, and/or JMP. Proven ability to interpret data by performing trend analysis Proven ability in technical writing skills Proven problem solving, decision-making skills,and troubleshooting abilities Good written and oral communication skills Ability to work in a collaborative to meet shared objectives in a dynamic and matrix team environment Proven ability to multi-task, be detail oriented, conscientious, motivated, flexible and ability to handle multiple projects

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 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: biologics, "separation chemistry" , "separation methods", "HPLC" , "UPLC" , Empower , "analytical chemistry" , protein

*LI-NW1 Submission for the position: Senior Scientist - Separation Methods - Biologics - HPLC - (Job Number: 189142)

Job posted: 2021-04-19

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