Scientist III

Pfizer • Andover, MA

9d • $82,700 - $137,900 • Onsite

About The Position

The qualified candidate will provide support for new and existing analytical method development and validation in a cGMP quality control analytical (QCA) laboratory. Supported activities include initial analytical method development, validations, qualifications and compendial verifications in support of clinical and commercial drug substance production. Analytical method validations for PAT methods within production suites will also be supported. A host of analytical techniques will be utilized, spanning a wide range of materials, including small molecules, gases, nucleotides, custom media, resins, polymers, salts, sugars, enzymes and others. This is a fast-paced group managing activities that are tied directly to the Andover production record. This role will also have a direct impact on Network Lab Strategy efforts aimed at harmonizing global analytical method strategy across 40 Pfizer sites.

Requirements

• Bachelor's degree with 6+ years of experience; OR a master's degree with at least 4 years of experience.
• Knowledge and practical application of relevant basic spectroscopic and chromatographic techniques
• Ability to efficiently manage personal project timelines well is a must
• Working understanding of cGMPs and regulatory guidance
• Experience with GC and HPLC
• 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.)
• Excellent oral and written communication skills
• Permanent work authorization in the United States.

Nice To Haves

• Experience with Raman spectroscopy preferred
• Experience in method troubleshooting and laboratory investigations preferred
• Working understanding of IMEx principles preferred
• Knowledge of Empower Software

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 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 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 various technical documents in support of new material validations/verifications, investigations and technical memos.
• Meet all timelines and deliverables in support of Andover plan of record and instrument qualifications (IQ/OQ/PQ).
• Execute method validations for PAT test methods within manufacturing operations.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level