Principal Scientist, Extractable, Leachables and Mass Spectrometry

Job Description

Pfizer is excited to present an opening for a Principal Scientist, with the unique opportunity to be part of a team that provides Extractable, Leachable and Impurity ID support for developing breakthrough medicines by utilizing innovative workflows and novel analytical techniques.

In a key role, the Principal Scientist, will primarily be responsible for leading Extractables, Leachables and Impurity ID activities for assigned projects, including but not limited to developing timelines and work plans. The incumbent will also:

• Support product development, by leading extractables/leachables and impurity identification activities.
• Lead a group of scientists to high productivity in a regulated environment.
• Routinely design complicated experiments that lead to a fundamental understanding of extractables, leachables (E&L) and drug's stability characteristics as a function of the designated drug delivery system.
• Prepare, review and approve technical documents, including E&L study plans, study protocols and reports, analytical test procedures and other technical reports.
• Effectively function as an E&L representative on project teams and provide regular updates on progress of projects.
• Discuss projects needs and questions with product development teams and lead technical meetings.
• Allocate, schedule, and manage laboratory resources to support extractable/leachable activities and prioritize laboratory work and support from cross-functional teams.
• Work directly with external CDMO's as needed, including some domestic and international travel.
• Manage and lead analytical method development and validation activities to support extractable and leachable studies.
• Independently perform all chemistry technique assignments including chromatography and mass spectrometry, and able to troubleshoot all analytical instrumentation.
• Make routine use of scientific literature, and have a good understanding of the disciplines beyond chemistry and pharmaceutics that also play into drug development including intellectual property (IP) protection, regulatory strategy, process technology, etc.
• When assigned direct reports (technical supervision), responsible for colleague professional growth and for contributing to performance reviews.

Role Responsibilities

• Leads and plans analytical laboratory assignments and activities to meet established project goals and timelines.
• Partners and collaborates with other scientists to help develop innovative approaches and work together for successful project deliveries.
• Allocates, schedules, and manages laboratory resources to coordinate E&L project work and prioritize laboratory activities.
• Directly or through others, performs LC/MS, LC/MS/MS or GC/MS method development and executes method validations and method transfers
• Designs and executes studies to meet requirements in USP and .
• Prepares and reviews technical documents, including validation protocols and reports, analytical test procedures, technical reports, and change controls. Provide the necessary documentation for regulatory submissions as required and writes deficiency responses
• Ensures that the analytical procedures they develop, review or establish conform to current and appropriate scientific, compendial and regulatory standards, and are suitable for use for their intended purpose
• Conducts investigations in the areas of method performance and reliability and evaluates proposed changes to compendia or developed methods
• Writes protocols or propose specifications based on USP, ICH or other compendial or regulatory requirements
• Assists in performing laboratory investigations
• Work directly with parties beyond PharmSci/R&D, including but not limited to 3rd party analytical labs, Contract Manufacturing Organizations (CMO's), and involvement with other divisions of Pfizer
• Provides training, technical expertise and support to the analytical staff
• Prepare and implement SOPs. Identifies opportunities for quality enhancement and operational efficiencies and develops efficient methodologies to track the progress.
• Evaluates new or state-of-the-art technology for potential use for characterization and assessment of key drug product attributes
• Performs duties with a high level of independence, flex in highly dynamic environment.

Basic Qualifications

• Bachelor's degree in the physical or biological sciences with 12+ years of industry experience, MS with 9+ years of industry experience or PhD degree with 4+ years of industry experience
• Must have strong background in leading extractables and leachables activities for pharmaceutical and drug device combination products.
• Experience in management and direction of laboratory activities to support extractable and leachable studies.
• Strong background in chromatography, mass spectrometry and other spectroscopic techniques
• Strong written and oral communication skills and the use of MS Office (Word, Excel) are required.

Preferred Qualifications

• Ability to synthesize data, extract key information, and articulate important data and recommendations.
• Strong communicator, able to establish and build relationships.
• Planning and organizing work with a track record of on time delivery.
• Innovative, continuous improvement mindset.

Other Job Detail

• Last Date to Apply: May 25, 2022
• Eligible for Employee Referral Bonus
• Eligible for Relocation Package

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Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Research and Development

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