Pfizer

Scientist

Employer
Pfizer
Location
Chesterfield, Missouri
Salary
Competitive
Posted
February 18 2021
Ref
4805440
Position Type
Full Time
Organization Type
Pharma
ROLE SUMMARY

The qualified candidate will join the Analytical R&D organization to enable development of biotherapeutics in Chesterfield, MO. Within Analytical R&D the candidate will join the Project Progression & Biochemistry Group focused on monoclonal antibodies, vaccines and other biological modalities. This group develops analytical methodologies and strategies needed to progress biotherapeutic products in the pipeline; this includes method development, process support, formulation and stability support, product characterization, method qualification, method validation and method transfer. The candidate will be working in a breadth of analytical methodologies including HPLC and CE and applying these methods to a broad range of biotherapeutics. The candidate must be able to interact effectively with multi-disciplinary project teams. In addition, the candidate is expected to provide data interpretation for their teams and customers, and revise/review/author test methods, technical reports and regulatory filings. The above skills will be applied to a large platform of projects in all stages of development.

ROLE RESPONSIBILITIES
  • Technical Leader: provide technical leadership in the characterization of biotherapeutics.
  • Responsible for building key analytical strategies and the development, validation and transfer of assays for release and characterization of biotherapeutics.
  • Writing and reviewing technical reports, SOPs, validation reports, and regulatory documents (e.g., INDs, BLAs and queries).


QUALIFICATIONS:
  • BS (6+ yrs) or MS (4+ yrs) in analytical chemistry or related field.


MINIMUM EXPERIENCE:
  • Experience with interdisciplinary drug development teams and industrial experience developing chromatographic and electrophoretic assays to assess the quality and characteristics of biotherapeutic drug candidates.
  • Experience working in a regulated environment (e.g. GLP, cGMP). 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 is a must.


DESIRABLE EXPERIENCE:
  • The ideal candidate will have experience developing and using the following techniques: modes of HPLC or CE for analysis and/or characterization of biologicals including; proteins, antibodies, oligonucleotidesor vaccines.
  • ICH method validation experience is valued.
  • Direct experience authoring and reviewing regulatory documents and working with FDA or European regulatory authorities is valued.
  • Understanding of emerging high-throughput technology platforms and applications to sample preparation and analysis.
  • Other desired attributes are:
  • Experience with mass spectrometry
  • Experience in lipid and/or surfactant analysis
  • Experience with method development and qualification


PHYSICAL/MENTAL REQUIREMENTS
  • Position requires occasional light lifting and periods of standing, sitting or walking.


Other Job Details:
  • Last Date to Apply for Job: February 25, 2021
  • Eligible for Employee Referral Bonus: YES


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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