Pfizer

Scientist Analytical Method Validation

Employer
Pfizer
Location
Chesterfield, Missouri
Salary
Competitive
Posted
November 20 2020
Ref
4796614
Position Type
Full Time
Organization Type
Pharma
ROLE SUMARRY

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. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, 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 RESPONSIBLITIES
  • As aqualified candidate you will be a scientist in an analytical organization (Analytical R&D). You will be expected tolead and participate in validation and transfer of industry-leading analytical technologies applied to advance biotherapeutic products into commercialization.
  • You will be directlyresponsible for the validation and lifecycle management of late-stage analytical, quality-controlled methods as they are established in commercial manufacturing sites.
  • As a successful candidate you will be expected todeliver results in a fast-paced matrix-oriented setting.
  • You will be a directcontributor to the design and execution of analytical method validations in accordance with ICH guidelines and internal quality standards.
  • The portfolio of products supported by the validation groupof which you will be a part includes antibodies, antibody-drug conjugates, therapeutic proteins, vaccines, and gene therapies.


QUALIFICATIONS
  • You must have in-depth scientific knowledge and experience in the development, validation and evaluation of robustness of analytical methods covering a wide array of techniques.
  • An in-depth knowledge of ELISA, qPCR, ddPCR is highly desirable as well as functional knowledge of separation analytical techniques such as AGE, HPLC, CE, and iCE is also a plus.
  • You will be expected to lead and be involved in cross-functional, analytical technology transfer teams across multiple sites in the United States, Europe and Japan.
  • These teams are responsible for the planning, coordination, execution, and communication of analytical responsibilities.
  • You will beresponsible for the timely execution of all aspects of the validation activities. As such, clear communication, organization and team influencing skills are required.
  • You willserve as an analytical and biochemistry resource for the department and project teams by proactively keeping colleagues at commercial launch sites aware of historical product knowledge and experience which includes product specifications, stability profiles, reference materials, critical reagents, and method development and robustness documentation.
  • You will beexpected to be a primary author, reviewer (both content and data verification), and approver of regulated documents such as method validation reports, protocols, and method transfer exercise protocols and reports.
  • Lastly the candidate is also expected to be aware of current scientific trends, strategies, and technical aspects from conferences, local meetings, and current scientific literature.


BASIC QUALIFICATIONS
  • Bachelor's Degree with 6+ years of experience
  • Experience with laboratory data systems
  • Provides attention to detail and good at documentation method validation experience.
  • Ability to extract relevant information from scientific literature, accurately record observations, facts, data and conclusions during experimental work or Good Manufacturing Practices {also cGMP} investigations.
  • Good knowledge of fundamental biochemistry, protein chemistry, macromolecular functions and interactions.
  • Interact effectively with peers and leaders as part of a multi-disciplinary team
  • Effective verbal and written communication skills


PREFERRED QUALIFICATIONS

  • Master's Degree with 4+ years of experience
  • Experience in a {Current} Good Manufacturing Practices {part of GxP} laboratory.
  • Understanding of various scientific software or software used in pharmaceutical or production environment.
  • Good Laboratory Practices (part of GxP)/Good Manufacturing Practices (also cGMP) knowledge.
  • Desire to develop their own technical skill set is essential.
  • Coursework in Statistics.
  • Direct experience working with late-stage clinical development or approved products.
  • Knowledge and experience in Critical Quality Attributes (CQA) principles and practices and product specifications and specification setting.
  • Demonstrated technical skills and scientific expertise in analytical method development and troubleshooting in one or more of the areas listed above.
  • Able to deliver results in a fast paced environment and effective communication to project teams.
  • Desire to train and develop colleagues, comfortable delegating. Highly skilled in Microsoft Excel and Word.
  • Change agile and functional in a fast-paced team environment where multi-tasking is required.
  • Effective in communicating to a broad range of stakeholders (from novices to experts) and skilled in establishing agreement in complex situations.
  • Curiosity about seeking and applying current relevant scientific literature.


PHYSICAL/MENTAL REQUIREMENTS
  • Position requires occasional light lifting and periods of standing, sitting or walking.
  • Ability to perform mathematical calculations and ability to perform complex data analysis .


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Occasional travel may be required.


Other Job Details:
  • Last Date to Apply for Job: December 18th 2020
  • Eligible for Employee Referral Bonus: YES


#LI-PFE

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

Similar jobs

Similar jobs