Senior Scientist, Extractables and Leachables

Employer
Pfizer
Location
Remote, Missouri, Missouri
Salary
Competitive
Closing date
Jul 2, 2022

View more

Sector
Science, Pharmaceutical
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. As a member of the Pfizer team, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

ROLE SUMMARY

Pfizer is excited to present an opening for a Senior Scientist, with the unique opportunity to provide Extractable and Leachable (E&L) oversight and support for developing breakthrough medicines by strategizing and working with Contract Research Organizations (CROs).

In a key role with the potential to be a remote position, the Senior Scientist will primarily be responsible for leading and coordinating E&L activities for assigned biotherapeutic projects, including but not limited to developing timelines and work plans. The incumbent will also:
  • Support product development by leading E&L and impurity identification activities by working with a CRO
  • Routinely design intricate experiments that lead to a fundamental understanding of extractables, leachables, and a 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, process contact risk assessments and other technical reports
  • Effectively function as an E&L representative on project teams and provide regular updates on progress of projects
  • Discuss project needs and questions with product development teams
  • Work directly with external CROs as needed
  • Manage and coordinate method development and validation activities to support E&L studies
  • 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


ROLE RESPONSIBILITIES:
  • Partners and collaborates with other scientists to help develop innovative approaches and work together for successful project deliverables
  • Designs and coordinates studies to meet requirements in USP and
  • Prepare, review, and/or approve technical documents, including E&L study plans, validation protocols and reports, analytical test methods and other technical reports
  • Ensures that developed analytical procedures conform to current and appropriate scientific, compendial and regulatory standards, and are suitable for their intended purpose
  • Work directly with the drug safety group as well as external CROs to support and ensure completion of extractable and leachable activities
  • Provide training, technical expertise and support to other E&L specialists
  • Author E&L sections of regulatory documents
  • Author responses to regulatory queries pertaining to E&L
  • Populate and maintain systems (e.g. dashboards, job aids, etc.) that enable consistency and efficiency across all Analytical R&D E&L specialists
  • Perform duties with a high level of independence and flexibility in a highly dynamic environment


BASIC QUALIFICATIONS:
  • Ph.D. (0-3 years), MS (>7 years) or BS (>10 years) in analytical or biophysical chemistry, biochemistry, or related field
  • Experience with performing and/or leading extractables and leachables activities for pharmaceutical or biotherapeutic products
  • Proven record of delivering results in a fast-paced environment and effective communication to project teams and external partners (e.g. regulatory authorities)
  • Demonstrated technical writing skills
  • Outstanding leader behaviors and the ability to collaborate with and mentor others.
  • Background in chromatography, mass spectrometry and other spectroscopic techniques
  • Strong background with methods development and GMP validation procedures


PREFERRED QUALIFICATIONS:
  • Direct experience authoring and reviewing regulatory documents and working with FDA or European regulatory authorities
  • Ability to synthesize data, extract key information, and articulate important data and recommendations
  • Strong communicator, able to establish and build relationships
  • Ability to plan and organize work with a track record of on-time delivery
  • Experience working with CROs a plus


PHYSICAL/MENTAL REQUIREMENTS

Ability to perform mathematical calculations;

Ability to perform complex data analysis

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Periodic travel required (up to 20% of time) to meet business partners face to face

Other Job Details

Eligible for Employee Referral Bonus

Last Day to Apply: July 8, 2022

#LI-PFE

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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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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