Use Your Power for Purpose
Seeking a detail-oriented person to work with members of the Quality Stability Program Management team to support the design, development, implementation and maintenance of stability protocols and studies for a commercial product and a variety of late phase clinical products both internal and at external manufacturing facilities. This position will include the comprehensive review and assessment of stability data (including trending and analysis), providing quality stability reports suitable for regulatory submission, and authoring stability sections of regulatory documents in support of IND's, BLA's, PMA's, MAA's, etc. In addition, the candidate may be required to represent the department at internal meetings or during regulatory regarding product stability information and data.
The Stability Specialist IV has a strong understanding of corporate and regulatory requirements necessary to support stability programs. Independently analyzes stability data to assure product specification and conformance to regulations are met. Recognizes atypical or out-of-specifications test results and notifies management immediately.
The Stability Specialist IV has knowledge of stability procedures and systems, performs a variety of complex tasks in compliance with cGMP's. Analyzes and interprets stability data and test results, as well as prepares data for statistical analysis and writes stability reports and annual reports. Leads investigations and troubleshoots stability issues.
Interacts with others to support stability activities and mentors team members.
What You Will Achieve
Responsible for development, implementation and maintenance of stability protocols and studies for a variety of late phase clinical as well as commercial products
Responsible for enrollment of new and existing products for annual commitment and Process Validation Stability Studies
Responsible to author cGMP stability protocols, reports and request forms
Responsible for managing stability of products produced internally as well as by a contract manufacturing facility
Responsible for change controls, annual reports, APQRs, YBPRs, regulatory filings and technical reports.
Managing stability studies and data in LabWare LIMS
Preparing information for and supporting regulatory audits.
Identifying stability related issues and solve these under the guidance of the Manager.
Analyzing and interpreting stability data and test results and participates in the decision if follow-up actions are required
The successful candidate must be able to work independently on multiple projects and meet established timelines.
Represent the department on inter-departmental project teams that are developing/improving processes and systems to ensure compliance with cGMPs and anticipate the introduction of new requirements
With a strong knowledge of stability procedures and systems, independently perform a variety of routine and non-routine tasks in compliance with cGMP’s
Lead/co-lead stability projects for new product introduction, change controls for shelf life extension and regulatory responses
Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables) within a Work Team
Act as a stability subject matter expert (SME) within the stability team and on cross functional teams
Independently identify new ideas and lead/co-lead the work to evaluate and implement
A decision maker for stability impact assessments on investigations, temperature excursions and change controls.
Partner with members of QC, QA, Pharmaceutical Sciences on stability program design and post market changes.
Identifies areas of improvement within the business and may lead continuous improvement activities
Promote a culture of innovation and continuous improvement.
Serve as a stability SME to review work completed by other colleagues in other areas.
Provide guidance and training to more junior staff members on stability guidance and procedures.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience;
OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience
2-4 years of stability program experience required.
Relevant Quality experience, preferably in the bio/pharmaceutical industry.
General knowledge of stability and cGMPs.
An understanding of biologics stability testing, FDA, ICH, and applicable stability regulations is required.
Experience authoring filings and responses to health authorities.
Knowledge in statistical concepts for appropriate interpretation of stability data (e.g. trending analysis)
Strong technical writing skills.
Proficiency with computer systems (Microsoft Office applications. LIMS, etc.)
Computer skills in MS Word, EXCEL, Access, data analysis software and LIMS desirable.
Experience with LabWare LIMS, QTS Trackwise, PDOCS or similar document management systems.
Strong interpersonal and communication (written and oral) skills and the ability to work well in a team environment are essential).
Bonus Points If You Have (Preferred Requirements):
A knowledge of protein stability and a good understanding of cGMPs is preferred.
An understanding of biologics stability testing and requirements as well as knowledge of FDA, ICH, and applicable stability regulations are a plus.
Experience managing stability of products produced by a contract manufacturing facility.
PHYSICAL/MENTAL REQUIREMENTS
Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office.
Ability to perform mathematical calculations and to perform complex data analysis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Position is first shift Monday through Friday.
OTHER JOB DETAILS
Last Date to Apply for Job: May 14, 2026.
Referral Bonus Eligibility: YES
Eligible for Relocation Package: NO
Work Location Assignment: Onsite
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
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. This position requires permanent work authorization in the United States.
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