Senior Scientist - Regulatory Filing - Project Management - Biologics

Submission for the position: Senior Scientist - Regulatory Filing - Project Management - Biologics - (Job Number: 178675)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 aSenior Scientist, you will collaborate across the analytical development, global quality product leads, technical project teams, and regulatory leads to support the pre- and commercial filings for drug substance and drug product regulatory filings life cycle. You will operate in a matrix team responsible for preparation of licensure applications, rest of world filings, follow-up measures, post-approval commitments and prior approval submissions.

Through strong leadership, you will ensure the support of analytical related sections of filings as well as the associated analytical change controls. You will also be responsible for data gathering, interpretation and presentation of results to support decision-making and product analytical strategies.

Additional responsibilities for the role on site at a major biopharmaceutical company:Create and maintain effective partnerships with stakeholders from analytical development, manufacturing sciences and technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to support delivery of analytical strategies with a high probability of technical and regulatory success.Manage and coordinate analytical activities for late-stage and commercial programs.Effectively support matrix teams for analytical work related filing sections for BLAs, ROW & PAS and work with analytical development in support of responses to FUMs and PMCs

Participates on the implementation of effective control strategies and analytical method and specification change controls, as needed throughout the client network, third party manufacturing and outside testing labs.*** This position is a non-lab based position

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!

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.

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 aSenior Scientist, you will collaborate across the analytical development, global quality product leads, technical project teams, and regulatory leads to support the pre- and commercial filings for drug substance and drug product regulatory filings life cycle. You will operate in a matrix team responsible for preparation of licensure applications, rest of world filings, follow-up measures, post-approval commitments and prior approval submissions.

Through strong leadership, you will ensure the support of analytical related sections of filings as well as the associated analytical change controls. You will also be responsible for data gathering, interpretation and presentation of results to support decision-making and product analytical strategies.

Additional responsibilities for the role on site at a major biopharmaceutical company:Create and maintain effective partnerships with stakeholders from analytical development, manufacturing sciences and technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to support delivery of analytical strategies with a high probability of technical and regulatory success.Manage and coordinate analytical activities for late-stage and commercial programs.Effectively support matrix teams for analytical work related filing sections for BLAs, ROW & PAS and work with analytical development in support of responses to FUMs and PMCs

Participates on the implementation of effective control strategies and analytical method and specification change controls, as needed throughout the client network, third party manufacturing and outside testing labs.*** This position is a non-lab based position

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!

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.

Education and Experience:Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, or similar scientific field or equivalent and relevant formal academic / vocational qualification with experience as described below.

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 in Biopharma industry

Experience working with LIMS, Excel, and Word

Experience in supporting regulatory filingsKnowledge, Skills and Abilities:Comprehensive knowledge/understanding of analytical methods and procedures routinely used for in process, release and stability testing of Protein Therapeutics as well as for protein characterization.

Knowledge of biologics CMC regulations and cGMP requirements, as well as, supporting filings preferred

Proficient in Microsoft Excel and Word, JMP, Empower, and LIMSProven ability to interpret scientific data by performing trend analysisProven ability in technical writing skillsProven problem solving and troubleshooting abilitiesGood written and oral communication skillsTime management and project management skillsAbility to work in a collaborative work environment with a teamWorking 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 mannerAble to work upright and stationary and/or standing for typical working hours as well as sitting, standing, walking, and repetitive motions.

Able to lift and move objects up to 25 poundsAble to work in an open office environment, working alone, working with/around others, working with computers and participation in group meetings, and non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyMay have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environmentsAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesRegular and consistent attendance

Keywords: "analytical chemistry" , "Project lead" , "project manager" , "project management" , "GMP" , "CMC" , "protein" , "biopharmaceutical" , "biopharma" , "regulatory"

PPDFSP

*LI-NW1

Education and Experience:Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, or similar scientific field or equivalent and relevant formal academic / vocational qualification with experience as described below.

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 in Biopharma industry

Experience working with LIMS, Excel, and Word

Experience in supporting regulatory filingsKnowledge, Skills and Abilities:Comprehensive knowledge/understanding of analytical methods and procedures routinely used for in process, release and stability testing of Protein Therapeutics as well as for protein characterization.

Knowledge of biologics CMC regulations and cGMP requirements, as well as, supporting filings preferred

Proficient in Microsoft Excel and Word, JMP, Empower, and LIMSProven ability to interpret scientific data by performing trend analysisProven ability in technical writing skillsProven problem solving and troubleshooting abilitiesGood written and oral communication skillsTime management and project management skillsAbility to work in a collaborative work environment with a teamWorking 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 mannerAble to work upright and stationary and/or standing for typical working hours as well as sitting, standing, walking, and repetitive motions.

Able to lift and move objects up to 25 poundsAble to work in an open office environment, working alone, working with/around others, working with computers and participation in group meetings, and non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyMay have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environmentsAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesRegular and consistent attendance

Keywords: "analytical chemistry" , "Project lead" , "project manager" , "project management" , "GMP" , "CMC" , "protein" , "biopharmaceutical" , "biopharma" , "regulatory"

PPDFSP

*LI-NW1

Submission for the position: Senior Scientist - Regulatory Filing - Project Management - Biologics - (Job Number: 178675)