PPD Senior Scientist - Biologics , CMC , Quality , Analytical Chemistry in Devens, Massachusetts
*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 SeniorScientist, 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)
Experience in Biopharma industry
Experience working with LIMS, Excel, and Word
Experience in supporting regulatory filings
Knowledge, 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 LIMS
Proven ability to interpret scientific data by performing trend analysis
Proven ability in technical writing skills
Proven problem solving and troubleshooting abilities
Good written and oral communication skills
Time management and project management skills
Ability 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 manner
Able 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 pounds
Able 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 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
Regular and consistent attendance
Keywords: "analytical chemistry" , "Project lead" , "project manager" , "project management" , "GMP" , "CMC" , "protein" , "biopharmaceutical" , "biopharma" , "regulatory" , "biologics" , "quality control" , "QC" , "large molecule", "QC Analyst"
Organization: *US BU
Title: Senior Scientist - Biologics , CMC , Quality , Analytical Chemistry
Location: MA-Devens-FSP Devens MA
Requisition ID: 182320
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group
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