Quality Control Senior Scientist

ROLE SUMMARY

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.

ROLE 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.

BASIC QUALIFICATIONS

• Bachelor's Degree in Chemistry, Biology or related scientific discipline with a minimum of 8 years of applicable laboratory experience OR Master's Degree in Chemistry, Biology or related scientific discipline with a minimum of 6 years of of applicable laboratory experience OR PhD in relevant scientific discipline with a minimum of 2 years of applicable laboratory 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.
• 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 mentor junior scientists.
• Proficiency with computer systems (Microsoft Office applications, LIMS, etc.).
• Excellent oral and written communication skills and technical writing ability.

PREFERRED QUALIFICATIONS

• Working understanding of Operational Excellence principles preferred (i.e. Integrated Manufacturing Excellence - IMEx).
• Experience working within QTS (Trackwise) quality modules desirable.
• Knowledge of Empower Software preferred.
• Experience with raw material method qualification desirable.
• Experience with Raman spectroscopy desirable.

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, TAVEL, 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.

Other Job Details:

• Last Date to Apply for Job: 11 DECEMBER 2020
• Eligible for Relocation Package
• Eligible for Employee Referral Bonus
• #LI-PFE

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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