Sr Scientist - Gene and Cell Therapy

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health!

The Gene and Cell Therapy team at PPD’s GMP Laboratories in Middleton, WI performs stability and QC testing of gene and cell therapy products. These methods consist of both molecular and cellular biology instruments and applications designed to quantify and establish the identity, integrity, fidelity and potency that support demonstration of consistency and stability of a drug substance/product against the quality parameters established for these complex products. The data generated support: product development; regulatory submissions; and product lot release to meet international regulatory guidance and GMP quality system compliance requirements.

As a Senior Scientist, you are committed to excellence and high-quality results in your complex laboratory analysis of key pharmaceutical products. Beyond the bench, you work as a project leader with a strong sense of urgency aligned to our customers, and you are committed to delivering results.

Responsibilities: Support both molecular and cell-based assays for Gene and Cell Therapy products 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 Prepares study protocols, project status reports, final study reports and other project-related technical documents 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 Assists in designing method validation or method transfer protocols and establish project timelines Reviews, interprets, and analyzes data for technical, quality, and compliance to protocols, methods, SOPs, client criteria, and GMP or 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

PPD offers continued career advancement as a Scientist, as well as management and specialized opportunities in other departments within PPD.

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.

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.

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health!

The Gene and Cell Therapy team at PPD’s GMP Laboratories in Middleton, WI performs stability and QC testing of gene and cell therapy products. These methods consist of both molecular and cellular biology instruments and applications designed to quantify and establish the identity, integrity, fidelity and potency that support demonstration of consistency and stability of a drug substance/product against the quality parameters established for these complex products. The data generated support: product development; regulatory submissions; and product lot release to meet international regulatory guidance and GMP quality system compliance requirements.

As a Senior Scientist, you are committed to excellence and high-quality results in your complex laboratory analysis of key pharmaceutical products. Beyond the bench, you work as a project leader with a strong sense of urgency aligned to our customers, and you are committed to delivering results.

Responsibilities: Support both molecular and cell-based assays for Gene and Cell Therapy products 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 Prepares study protocols, project status reports, final study reports and other project-related technical documents 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 Assists in designing method validation or method transfer protocols and establish project timelines Reviews, interprets, and analyzes data for technical, quality, and compliance to protocols, methods, SOPs, client criteria, and GMP or 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

PPD offers continued career advancement as a Scientist, as well as management and specialized opportunities in other departments within PPD.

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.

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.

Qualifications

Education and Experience: Bachelor's degree or equivalent and relevant formal academic/ vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years)

Knowledge, Skills and Abilities: Proficient in use of analytical instrumentation such as HPLC, GC, MS, Dissolution Testing, Inhalation Testing (Cascade Impaction, Dose delivery, Particle Size analysis), BioPharmaceutical Testing (ELISA, Gel Electrophoresis), Karl Fischer, UV-Vis, FT-IR, TOCSolid understanding and knowledge of general chemistry and seperation scienceFull understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidanceAbility to utilize Microsoft Excel and Work to perform tasksMaintain a laboratory notebook and complete all documentation with clear and accurate language and according to the SOPProficiency on technical operating systemsProven problem solving and troubleshooting abilitiesEffective oral and written communication skillsProven ability in technical writing skillsTime management and project management skillsAbility to work in a collaborative work environment with a teamProven problem solving and troubleshooting abilitiesAbility to train junior staff

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 or laboratory environmentsAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesRegular and consistent attendance

Qualifications

Education and Experience: Bachelor's degree or equivalent and relevant formal academic/ vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years)

Knowledge, Skills and Abilities: Proficient in use of analytical instrumentation such as HPLC, GC, MS, Dissolution Testing, Inhalation Testing (Cascade Impaction, Dose delivery, Particle Size analysis), BioPharmaceutical Testing (ELISA, Gel Electrophoresis), Karl Fischer, UV-Vis, FT-IR, TOCSolid understanding and knowledge of general chemistry and seperation scienceFull understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidanceAbility to utilize Microsoft Excel and Work to perform tasksMaintain a laboratory notebook and complete all documentation with clear and accurate language and according to the SOPProficiency on technical operating systemsProven problem solving and troubleshooting abilitiesEffective oral and written communication skillsProven ability in technical writing skillsTime management and project management skillsAbility to work in a collaborative work environment with a teamProven problem solving and troubleshooting abilitiesAbility to train junior staff

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 or laboratory environmentsAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesRegular and consistent attendance