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PPD Senior Scientist - Analytical Chemistry - Biologics - Project Management in Devens, Massachusetts

Senior Scientist - Analytical Chemistry - Biologics - Project Management

Devens, Massachusetts, United States at

Labs at

Oct 09, 2019Post Date

253Total Views

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 Senior Scientist, you will collaborate across the client's sites with analytical development, global quality product leads, technical project teams, and regulatory leads to generate and execute the pre- and commercial strategies for drug substance and drug product methods and specifications, network analytical control strategies, and support of life cycle regulatory filings. 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, the scientist will ensure the support of analytical methods and analytical change control across the client network, for third party manufacturing and their partners at outside testing labs. The scientist is responsible for data gathering, interpretation and presentation 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 deliver analytical strategies with a high probability of technical and regulatory success, as necessary.

  • Manage and coordinate analytical activities for late-stage and commercial programs.

  • Effectively supports team matrix for analytical topics during all BLAs, ROW & PAS filing review and works with analytical development in supporting the responses to FUMs and PMCs.

  • Participates on the implementation of effective control strategy, analytical method and specification change control as needed throughout the client network, third party manufacturing and outside testing labs.

  • Serves as subject matter expert for project for activities, including technical evaluations of methods and data.

* 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.

Qualifications :

Education and Experience :

  • Bachelor's degree in Chemistry, Analytical Chemistry, or scientific field or equivalent and relevant formal academic / vocational qualification

  • 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 working with Empower, LIMS, and/or JMP preferred

  • Experience in supporting regulatory filings

Knowledge, Skills and Abilities:

  • Comprehensive knowledge in analytical methodologies used for the development and commercialization of biologics.

  • Demonstrates a broad experience in analytics routinely used for in process, release and stability testing of biologics or Protein Therapeutics drug substance and drug product and product characterization and strategies to establish process and product knowledge

  • Proficient in Microsoft Excel and Word, JMP, Empower, and LIMS

  • Working knowledge of biologics CMC regulations and cGMP requirements, as well as, supporting regulatory filings preferred

  • Proven ability to interpret data by performing trend analysis

  • Proven ability in technical writing skills

  • Ability to independently optimize analytical methods

  • 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

  • Able to lift and move objects up to 25 pounds

  • Able to work in non-traditional work environments

  • Able to use and learn standard office equipment and technology with proficiency

  • May have exposure to potentially hazardous elements 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

Additional Information

  • Requisition ID: 162956

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