QC Scientist III (Technical Support- 1st Shift)

ROLE SUMMARY

The qualified candidate will provide analytical support for in-process / drug substance for new and existing Products in a cGMP quality control analytical (QCA) laboratory. Supported activities include resin monitoring/excipient testing, analytical method optimization, qualifications, validations, comparability, and evaluation/implementation of new technologies. Troubleshooting activities in support of QC labs and manufacture is also included.

ROLE RESPONSIBILITIES

• Develop and validate analytical test methods, author test method documents, support specification and list of test method development and ensure effective method transfer from the technical support group to the release laboratory by training analysts.

• Draft and execute analytical method validation protocols in support of new and existing products

• Provide technical support for new analytical methods, method troubleshooting, investigations and method improvements

• Collaborate with site functional areas such as Site Technical Services, Manufacturing Sciences and Technology, Quality assurance and Manufacturing Operations to support the site plan of record.

• Support testing of excipients/impurities for resin/membrane monitoring programs/ Manufacture solution qualification.

• Support installation and/or sustainability of Integrated Manufacturing Excellence (IMEx) elements within the group.

• Identify technical issues, method performance issues, instrument malfunctions and methodology problems and participate in necessary investigations aimed at mitigation.

• Maintain all related data and records in compliance with cGMPs and quality procedures

• Write and review technical documents such as validation protocols and reports in support of product validations/qualifications/comparability and investigations and change controls.

• Meet all timelines and deliverables in support of Andover plan of record and product life cycle.

BASIC QUALIFICATIONS

• B.S. in Chemistry, Biology or related scientific discipline with 4+ years of applicable laboratory experience (Pharmaceutical or Biotechnology industry)

• M.S with a minimum of 2 years of relevant laboratory experience (Pharmaceutical or Biotechnology industry)

• Experience with HPLC, CE, gel, spectroscopy

• Knowledge and practical application of relevant analytical techniques

• Ability to efficiently manage personal project timelines well is a must

• Experience in method troubleshooting and laboratory investigations

• Experience with cGMPs and regulatory guidance

• Experience with protein preferred

• Possess strong problem solving skills

• Demonstrated planning and prioritization skills with a focus on team success in meeting defined timelines. A proactive team player.

• Proficiency with computer systems (Microsoft Office applications, LIMS, etc.)

• Knowledge of Empower Software

• Excellent oral and written communication skills

• Working understanding of IMEx principles preferred

PREFERRED QUALIFICATIONS

• Protein experience

• Separation techniques experience

• Strong troubleshooting skills

PHYSICAL/MENTAL REQUIREMENTS

• Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory, suites, etc.).

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support staff and operations.

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.