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.
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 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.
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.
- 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.
- 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.
- 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.
- 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.
• 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.
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