Scientist Job at Pfizer
Who We Are
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
What You Will Do
Provide technical leadership, support, and consultation regarding regulatory compliance as it pertains to Biocompatibility and Extractable and Leachable (E&L) of new and modified biomedical material in pharmaceutical medical device and combination products and other container closure systems. Serve as subject matter expert (SME) by providing related technical support of new product development, regulatory submissions, and manufacturing and engineering changes to meet business objectives. Effectively interfaces with R&D, preclinical, regulatory, operations, quality and contract research organization as authority in Biocompatibility safety assessment.
How You Will Achieve It
Independently coordinates biocompatibility testing of new and modified biomedical materials. Determines technical scope of needed testing and establishes and provides project cost and time estimates.
Works collaboratively across functions to effectively make recommendations, compile, review, and interpret test results relative to product biocompatibility requirements, material compatibility, definitions and/or program goals. Recommend further action as needed based on results.
Incorporates physical and chemical data to design risk assessment strategies for pharmaceutical medical device and combination products and other container closure system qualifications that may not be well-defined, have multiple variables, and require advanced technical approaches all within pre-negotiated timelines.
Maintains understanding and current knowledge of relevant global regulatory requirements specific to Biocompatibility testing (e.g., ISO10993 series, USP, and specific geographical requirements) and critically assesses emerging standards as it relates to pharmaceutical product development, design, maintenance, and safety to ensure compliance in all data collection and reporting activities.
Generates Biocompatibility assessment reports in support of regulatory filings (e.g., Premarket Notification 510(K), Drug Master File, PMAs). This includes maintenance and storage of historical reports for easy retrieval.
Provides chemical testing strategies for E&L design and performs risk-assessment based on test results.
Utilizes and maintains a global database for material management.
Maintains current knowledge of hemocompatibility, in vivo toxicology, and genotoxicity test methods.
Qualifications
- Applicant must have High School Diploma (or Equivalent) with eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience.
- 3+ years of direct biocompatibility experience highly preferred
- Technical knowledge of biocompatibility and general understanding of material physical and chemical properties.
- Ability to understand and apply updated global regulatory guidelines, including ISO 10993, ICH, USP, EP and JP necessary for providing guidance towards Biocompatibility and E&L testing. Experience working with regulated authorities would be preferred.
- Good oral and written skills necessary for cross-functional collaboration and execution at a high level.
- Excellent organizational skills and project management that allow multi-tasking on several concurrent projects.
- Excellent attention to analytical detail.
- Utilizes a logical, methodical approach in independently solving problems, developing solutions, and making recommendations.
PHYSICAL/MENTAL REQUIREMENTS
The Incumbent will be expected to function successfully in an office setting. The incumbent will be required to sit for long periods of time while viewing a computer monitor and using a keyboard. Routine visits to the laboratory for product testing evaluation can be required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional travel for job related training and development can be expected but will be dictated by project and business needs.
Work Location Assignment: On Premise
Last Date to Apply to Job: May 23, 2023
Relocation assistance may be available based on business needs and/or eligibility.
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.
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