This job posting may have expired!
Use our `search` to find similar offers.
Similar jobs

Research Scientist (Sr Scientist) - AUC Method Development and Validation, Biophysicals

Pharmaceutical Product Development (PPD)

WI-Middleton-Middleton WI Research Way

Submission for the position: Research Scientist (Sr Scientist) - AUC Method Development and Validation, Biophysicals - (Job Number: 169372)

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. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

The Research Scientist positionconducts and provides technical guidance on Analytical Ultracentrifugation (AUC) or other biophysical method development and validation projects. Performs troubleshooting for AUC and other instruments, methods, procedures, and in writing protocols and reports. Designs and executes method development/validation independently and interprets and reviews analytical data for self and others. Assists others in performing routine maintenance and troubleshooting on AUC or other biophysical instruments (CD, DSC, DLS etc.), methods and procedures. Routinely acts as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes reports and protocols

Responsibilities: Independently performs AUC development/optimization/validation and conduct routine AUC testing for AAV or other biologics products. Trains junior scientists in AUC or other biophysical technologies. Designs and executes experiments independently for self and others. Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents. Leads analytical (procedural and instrumental) troubleshooting sessions. Assists business development group in technical sales and marketing and presents posters at technical conferences. Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities 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. It's not just talk, our award-winning training programs speak for themselves.

Our teams support career growth whether you are looking for long term opportunities within the scientific ladder, to pursue project management, or develop into a leader -- these are just a few career pathways available once your become a part of the PPD team.

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

What To Expect Next

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

#PPDLABS

#LI-33456501_TG1

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. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

The Research Scientist positionconducts and provides technical guidance on Analytical Ultracentrifugation (AUC) or other biophysical method development and validation projects. Performs troubleshooting for AUC and other instruments, methods, procedures, and in writing protocols and reports. Designs and executes method development/validation independently and interprets and reviews analytical data for self and others. Assists others in performing routine maintenance and troubleshooting on AUC or other biophysical instruments (CD, DSC, DLS etc.), methods and procedures. Routinely acts as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes reports and protocols

Responsibilities: Independently performs AUC development/optimization/validation and conduct routine AUC testing for AAV or other biologics products. Trains junior scientists in AUC or other biophysical technologies. Designs and executes experiments independently for self and others. Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents. Leads analytical (procedural and instrumental) troubleshooting sessions. Assists business development group in technical sales and marketing and presents posters at technical conferences. Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities 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. It's not just talk, our award-winning training programs speak for themselves.

Our teams support career growth whether you are looking for long term opportunities within the scientific ladder, to pursue project management, or develop into a leader -- these are just a few career pathways available once your become a part of the PPD team.

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

What To Expect Next

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

#PPDLABS

#LI-33456501_TG1

Qualifications

Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 8 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.

Master's degree with 7 years of experience

PhD with 4 years of exp

Knowledge, Skills and Abilities:Demonstrated ability to apply AUC to analyze gene therapeutic products and other biologicsExtensive hands-on experience in performing and trouble-shooting AUC technique, preferred using SEDFIT software for data analysisExperience with other biophysical technologies is a plusFull understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidanceFull knowledge of technical operating systemsAbility to independently optimize analytical methodsAbility to independently perform root cause analysis for method investigationsProven technical writing skillsProven problem solving and troubleshooting abilitiesEffective written and oral communication skills as well as presentation skillsTime management and project management skillsAbility to mentor others on technical operating systemsAbility to independently review and understand project proposals/plansAbility to work in a collaborative work environment with a team

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 mannerAble to work upright and stationary and/or standing for typical working hoursAble to lift and move objects up to 25 poundsAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyMay have exposure to potentially hazardous elements typically found in healthcare of laboratory environmentsAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesQualifications

Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 8 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.

Master's degree with 7 years of experience

PhD with 4 years of exp

Knowledge, Skills and Abilities:Demonstrated ability to apply AUC to analyze gene therapeutic products and other biologicsExtensive hands-on experience in performing and trouble-shooting AUC technique, preferred using SEDFIT software for data analysisExperience with other biophysical technologies is a plusFull understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidanceFull knowledge of technical operating systemsAbility to independently optimize analytical methodsAbility to independently perform root cause analysis for method investigationsProven technical writing skillsProven problem solving and troubleshooting abilitiesEffective written and oral communication skills as well as presentation skillsTime management and project management skillsAbility to mentor others on technical operating systemsAbility to independently review and understand project proposals/plansAbility to work in a collaborative work environment with a team

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 mannerAble to work upright and stationary and/or standing for typical working hoursAble to lift and move objects up to 25 poundsAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyMay have exposure to potentially hazardous elements typically found in healthcare of laboratory environmentsAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesSubmission for the position: Research Scientist (Sr Scientist) - AUC Method Development and Validation, Biophysicals - (Job Number: 169372)

Job posted: 2020-07-16

3