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Senior Scientist - 2nd shift

Pharmaceutical Product Development (PPD)

KY-Highland Heights-Highland Heights KY Tessenee

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

PPD Laboratories offer the most comprehensive set of laboratory services available in the industry. Our services are designed to accelerate pharmaceutical development for small molecules, biologics, and vaccines, allowing our clients to make faster decisions about their compounds.

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.

Grow your career within the scientific ladder, pursue project management, or develop into a leader. These are just a few career pathways available once you choose to Be with PPD.

Join PPD in our relentless pursuit of excellence - apply now!Essential Functions:Performs complex laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation, calculates and analyzes data and records data in adherence with PPD SOP's and the industry. Routinely acts as the project leader on multiple projects, interacts with clients, reviews and evaluates data, writes reports and protocols. Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members.•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 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.PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offer the most comprehensive set of laboratory services available in the industry. Our services are designed to accelerate pharmaceutical development for small molecules, biologics, and vaccines, allowing our clients to make faster decisions about their compounds.

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.

Grow your career within the scientific ladder, pursue project management, or develop into a leader. These are just a few career pathways available once you choose to Be with PPD.

Join PPD in our relentless pursuit of excellence - apply now!Essential Functions:Performs complex laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation, calculates and analyzes data and records data in adherence with PPD SOP's and the industry. Routinely acts as the project leader on multiple projects, interacts with clients, reviews and evaluates data, writes reports and protocols. Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members.•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 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.

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 5 years’) or equivalent combination of education, training, & experience.

•Or PhD

Knowledge, Skills and Abilities:

•Solid understanding and knowledge of general chemistry and separation science

•Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance

•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

PPD Benefits Overview:

PPD offers comprehensive benefits including medical, dental, vision, pharmacy, employee assistance program, wellness program options and more.

Other benefits include:

•401k with matching contributions, life insurance, long term and short-term disability insurance, flexible medical and dependent care spending accounts.

•Work life balance programs including paid time off for vacation/sick time, paid holidays, floating holiday and vacation sell back program.

•Wellness benefits including health and wellness programs, fitness facility access or discount, health coaching and more.

•Education reimbursement and tuition assistance programs, professional development training, skills training, education loan repayment plan, dependent scholarship program and more.

•Employee appreciation events, service recognition awards, annual reviews, merit plans and bonus plans

•Community connections and activities including philanthropic engagement, volunteer service projects and more

•Other great options including pet insurance, legal and financial services plan, auto and home insurance discounts.

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 5 years’) or equivalent combination of education, training, & experience.

•Or PhD

Knowledge, Skills and Abilities:

•Solid understanding and knowledge of general chemistry and separation science

•Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance

•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

PPD Benefits Overview:

PPD offers comprehensive benefits including medical, dental, vision, pharmacy, employee assistance program, wellness program options and more.

Other benefits include:

•401k with matching contributions, life insurance, long term and short-term disability insurance, flexible medical and dependent care spending accounts.

•Work life balance programs including paid time off for vacation/sick time, paid holidays, floating holiday and vacation sell back program.

•Wellness benefits including health and wellness programs, fitness facility access or discount, health coaching and more.

•Education reimbursement and tuition assistance programs, professional development training, skills training, education loan repayment plan, dependent scholarship program and more.

•Employee appreciation events, service recognition awards, annual reviews, merit plans and bonus plans

•Community connections and activities including philanthropic engagement, volunteer service projects and more

•Other great options including pet insurance, legal and financial services plan, auto and home insurance discounts.

Job posted: 2020-08-19

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