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Sr. Scientist

Employer
Pfizer
Location
Pearl River, New York
Start date
Aug 2, 2022

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Discipline
Science/R&D, Biotechnology
Required Education
High School or equivalent
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work
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Job Details

ROLE SUMMARY

Consistently performs routine and more complex analytical chemistry activities with a high degree of independence. Demonstrates technical expertise in one or more analytical areas.

Develops and validates analytical methods relating to the support of marketed products. Compiles validation data into comprehensive reports. Transfers analytical methods in support of new product launches and existing marketed products. Applies creative ability and specialized scientific knowledge to solving marketed product analytical problems or evaluating changes to APIs and critical excipients used in marketed products. Evaluates and implements new measurement technologies to improve sensitivity, selectivity, and/or the ability to characterize API’s, excipients, in-process materials, and finished products.

Applies statistics to data analysis and the design of experiments. Generates analytical data for the purposes of determining the level of correlation to measurements that use Process Analytical Technology techniques.

Conduct Laboratory investigations, create Change Control, revise test methods, write protocol and perform approvals.

The position is accountable for ensuring that analytical measurements are accurate and that methods are in compliance with FDA and/or other applicable regulatory agency guidelines, cGMP, and corporate requirements.

Performs chemical, in-vitro, or in-vivo biological assays of clinical and/or commercial product raw materials, production intermediate and bulk samples, inprocess samples, finished product, sterility testing, environmental monitoring samples, process & cleaning validation samples, package samples and components as well as some specialized techniques. Assays are performed in compliance with USP, FDA and other regulatory body requirements, Pfizer standard operating procedures, and approved license requirements. In addition, the individual writes, reviews and approves protocols, reports, and investigations associated with the laboratory and to support method validation activities.

ROLE RESPONSIBILITIES

Conducts assays

In addition to high technical competence, the colleague understands and can articulate the scientific/regulatory principles that underlie practices and guide future projects/studies/reviews development.

Analyzes results

Analyzes and interprets project/study/investigation/review results independently. May utilize Laboratory Information Management Systems (LIMS). Develops problem solving skills. Makes tactical decisions independently based on the results.

Trains & Mentors

Trains analysts in new and existing procedures, techniques and governmental regulations as directed by management. Mentors analysts by providing technical knowledge and support in resolving technical problems. Takes initiative; seeks out additional assignments, etc.

Lab Support

Responsible for planning and execution of all tasks needed to achieve routine goals. Seeks advice on planning from management when there are priority conflicts. Maintains all related records, prepares and records media, buffers and reagents, etc., and maintains work area in a neat and orderly manner. May assist in coordinating the testing activities of the group.

SOPs and Admin

Able to make independent contributions to the development of new technologies developing and revising methods and procedures to assure compliance with applicable regulations; carries out technical and administrative duties as assigned.

Organizational Relationships

  • Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the role responsibilities. Include any external interactions as appropriate.
  • Manufacturing Work priorities, provide information, discuss problem batches, manufacturing/technical issues, deviations and other events with potential impact on product quality and/or supply.
  • Other Site Quality functions, other site functions; Q&C OpU contacts
  • For any relevant topic, as appropriate Site and Corporate Regulatory Affairs function Change Control process; Address and and resolve any potential issues with regulatory impact.
  • Provide support for queries and BOH filings Vendors, Contractors and other 3rd parties interactions with vendors, contract manufacturers, and other 3rd parties on any relevant Quality & Compliance issue, on joint projects and in routine business contacts Industry Committees, Trade Associations Representation of Pfizer; Information exchange and discussion of emerging regulations and regulatory expectations and their impact on the Industry.

This position is also responsible for providing time sensitive in-process testing in support of Operations as needed.

BASIC QUALIFICATIONS

  • Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
  • Knowledge of ICH and other applicable industry standards.
  • Understanding the principles of Data Integrity.

PREFERRED QUALIFICATIONS

  • Education: Chemistry or Biochemistry (degreed candidates)
  • 10 years experience within Quality Control or other relevant analytical experience in the pharmaceutical industry. General lab equipment. Equipment troubleshooting.
  • Prior experience in most, if not all, of the following: Making sound and effective decisions under pressure. Working with other manufacturing sites to understand a broader perspective. Exposure to Regulatory inspections including direct interactions. Ability to effectively work within Quality Control, and across network channels, to accomplish goals.

PHYSICAL/MENTAL REQUIREMENTS

  • Ability to perform mathematical calculations
  • Ability to perform complex data analysis

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Responsible for ensuring time-sensitive in-process lab testing is performed in support of Operations. This may require adjusting work hours as required or needed.

OTHER INFORMATION

• Last Date to Apply for Job: August 25, 2022
• Eligible for Relocation Package: No
• Eligible for Employee Referral Bonus: Yes

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.

Quality Assurance and Control

#LI-PFE

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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