Address
Form of work
SalaryWhy Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
The qualified candidate will provide support for new and existing raw material analytical method development and validation work within a technical support group at Pfizer Andover. Materials range from small organic and inorganic molecules to resins, custom media, larger macromolecules, enzymes and nucleic acid precursors and fatty acids. Methods are of compendial and non compendial nature. 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 in-process manufacturing test methods involving key components will also be supported. Support for particle and impurity identification within drug substance manufacturing will also be provided by the qualified candidate.
How You Will Achieve It
- 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 Tech Support group 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 to execute impact assessments and document required qualification actions).
- This role could require up to 50% non-lab support work.
Qualifications
Must-Have
- Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ 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
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.).
ORGANIZATIONAL RELATIONSHIPS
Collaborate with QC management, Global Procurement, Manufacturing Operations, Quality Assurance, Site Technical Services and Pharmaceutical Sciences as required. Participate in network teams (BPOG, RM CIG) as appropriate.
This description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required.
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.
Work Location Assignment: Flexible
OTHER JOB DETAILS
- Last Date to Apply for Job: December 14, 2023
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: NO
Relocation assistance may be available based on business needs and/or eligibility.
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.
