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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)

OR

  • PhD

Preferred Experience:

  • 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

Working 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 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"

*LI-NW1

Job: *Labs

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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