Senior Scientist I

Why Patients Need You 

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.   

 

What You Will Achieve 

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification, and sterility testing will help Pfizer provide safe drugs to patients. Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of technology/methodology from R&D. 
As a Senior Scientist, you will be at the center of our operations and you’ll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be recognized as a technical expert and a scientific contributor. With your deep knowledge of the discipline, you will be an active team member whose decisions impact the project. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience. You will be forecasting and planning resource requirements for your project team.  Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide team members.  

It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe. 

 

How You Will Achieve It  

• Apply technical and functional knowledge to design experiments, and independently complete work within own work group/ project team, working on multiple sub-projects in parallel.  

• Act as a technical and scientific resource within own project team/ discipline. 

• Perform tasks associated with maintaining and improving cGMP (current Good Manufacturing Practices) compliant Quality Control and/or Stability laboratories. 

• Apply discipline’s principles, appropriate procedures, and leadership skills to develop action plans and contributes to executing toward individual, team, and project goals. 

• Perform testing including, but not limited to clinical and/or commercial product, raw materials, validation, stability. 

• Train junior colleagues and develop training plans and/or oversee training activities for groups.  

• Support audits and review/approve technical content ensuring both scientific merit and compliance to regulatory agency regulations and Pfizer policy and standards. 

• Design and create protocols related to compliant test method transfer and validation. 

• Organize reports and records related to equipment qualification/computer validation. 

• Assist with protocol non-conformance evaluations. ​

• Identify and seek out external resources (e.g. Parenteral Drug Association, International Society for Pharmaceutical Engineering) to build or enhance understanding of scientific discipline. 

• Collaborate/independently engage with a wide range of co-workers, customers, and management within the network to gather the input and background knowledge needed to complete assignments. 

• Assess existing situations and suggest continuous improvements to increase compliance and innovation. 

 

The qualified candidate will provide support for new and existing raw material analytical method development in a cGMP quality control analytical (QCA) laboratory.  Supported activities include initial raw material analytical method development, validations, qualifications and compendial verifications in support of clinical and commercial drug substance production. Analytical method validations for key components within in-process drug substance and cell culture mixtures within production suites will also be supported.

Responsibilities

• Own and drive the QCA end of the new material qualification process. Independently develop and validate analytical test methods, author test method documents, support specification 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 material qualification
• Provide technical support for new analytical methods, method troubleshooting, investigations and method improvements
• Collaborate with site functional areas such as Global Procurement, Quality Assurance, Site Technical Services and Manufacturing Operations to support the site plan of record. 
• 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 new material validations/qualifications/verifications and investigations and change controls.
• Represent the Quality Control Analytical department in cross functional and site product meetings. 
• Meet all timelines and deliverables in support of Andover plan of record and instrument qualifications (IQ/OQ/PQ).
• Work within the Quality management system (QTS Trackwise) to execute impact assessments and document required qualification actions).
• This role could require up to 50% non-lab support work.

Qualifications  

• B.S. in Chemistry, Biology or related scientific discipline with a minimum of 8 years of applicable laboratory experience, M.S with a minimum of 6 years of experience or PhD with a minimum of 2 years of experience.
• Extensive knowledge and practical application of relevant analytical techniques and associated validation and verification activities
• Ability to efficiently and independently develop analytical methodology and manage personal project timelines well is a must
• Ability to make strategy-based recommendations directed to method validation approach
• Experience in method troubleshooting and laboratory investigations
• Experience with cGMPs and regulatory guidance
• Expertise with GC and HPLC
• Experience with raw material method qualification desirable
• Experience with Raman spectroscopy desirable
• Strong independent problem solving and technical writing skills
• Demonstrated leadership skills in decision making, planning and prioritization with a focus on team success in meeting defined timelines. A proactive team player
• Ability to train and supervise junior scientists
• Proficiency with computer systems (Microsoft Office applications, LIMS, etc.)
• Knowledge of Empower Software preferred
• Excellent oral and written communication skills and technical writing ability  
• Working understanding of IMEx principles preferred
• Experience working within QTS (Trackwise) quality modules desirable

Other Job Details:

• Last Date to Apply: 9/21/2021

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

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