Senior Scientist, Mass Spectrometry, Analytical R&D (4844639_Lake_Forest)
Pfizer is excited to present an opening for a Sr. 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 Sr. Scientist, will primarily be responsible for supporting Extractables, Leachables and Impurity ID activities for assigned medium to large projects, including but not limited to developing timelines and work plans. Reporting to a Group Leader, the incumbent will also:
- Lead LC-MS activities contributing to extractables, leachables and impurity identification studies.
- Act as a primary LC-MS contact for the E&L team, discuss findings with the team to generate conclusions and lead technical meetings.
- Lead method development and validation activities to support new drug product development.
- Investigate method performance, reliability and improvement issues, and evaluate proposed changes to compendial or in-house methods.
- Independently perform all chemistry technique assignments including chromatography and mass spectrometry, and able to troubleshoot all analytical instrumentation.
- Prepare and review technical documents, including validation protocols and reports, analytical test procedures and technical reports.
- 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.
- Work directly with external CDMO’s as needed, including some domestic and international travel.
- 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.
- Effectively function as a PharmSci representative on project teams.
- Coach junior chemists in various analytical techniques including HPLC and Mass Spectrometry.
- 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.
- Performs qualitative and quantitative LC-MS analysis of pharmaceutical and drug device combination products to support extractable and leachable studies. Process and report data per Pfizer SOPs and industry guidance.
- Utilizes high resolution LC-MS instruments to identify and quantify unknown extractable and leachable impurities.
- Directly or through others, performs method development and executes method validations and method transfers.
- Designs and executes studies to meet requirements in USP <1663> and <1664>.
- 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 LC-MS training, technical expertise and support to the analytical staff.
- 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.
- Bachelor’s degree in the physical or biological sciences with 9+ years of industry experience, MS with 7+ years of industry experience or PhD degree with 0-3 years of industry experience
- Strong background in separation science and analytical detection techniques including mass spectrometry.
- Must have hands-on experience in mass spectrometry with a focus on LC-MS, LC-MS/MS, High Resolution LC-MS and other spectroscopic techniques.
- Proficient in the use and understanding of LC-MS data acquisition and data processing software.
- Small molecule structure elucidation experience using high resolution accurate mass
- Demonstrated ability in method development and validations in a GXP environment.
- Strong written and oral communication skills and the use of MS Office (Word, Excel) are required.
- 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: April 29, 2022
- Eligible for Employee Referral Bonus
- Eligible for Relocation Package
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#LI-PFE