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LEAD INVESTIGATOR

Pfizer – Andover, MA

Role Summary:

The Andover Site Operations Management group is looking for an individual to fill a Lead Investigator position within the Investigations group. The Andover Site Investigation group is responsible for overseeing investigations for all GMP manufacturing suites and laboratories in Andover, including both mammalian and bacterial based processes in support of commercial and clinical Drug Substance manufacture. The candidate will be responsible for performing thorough, detailed and timely investigations and for the generation of high quality investigation reports. This position will report to the Manager of Investigations within the Site Operations Management Department.

Role Responsibilities:

The candidate will be responsible for performing thorough, detailed and timely investigations and for the generation of high quality investigation reports.

The individual will be expected to develop collaborative relationships with the operations, laboratory, quality, and other supporting groups in order to facilitate investigations using continuous improvement techniques. The incumbent will be expected to have experience in the area of quality and compliance and a working knowledge of GMPs. Experience with and in depth understanding of cell culture and chromatography is highly desirable. The candidate will be expected to assist in continually defining and improving the philosophy tools for investigations to meet changing business needs.

Additional responsibilities and expectations include:

  • Have a fundamental understanding of the investigation process as it applies to manufacturing and laboratory issues
  • Have detailed understanding of the processes and systems involved in the manufacture of bio pharmaceuticals. Be able to use that knowledge to investigate process deviations and atypical results.
  • Ensure investigations are conducted with a strict adherence to appropriate quality and compliance standards
  • Ability to coordinate and facilitate meetings, lead conversations, and influence teams
  • Work under limited supervision, with the ability to problem solve, manage priorities, and make decisions independently.
  • Drive/contribute to the completion of complex projects and take responsibility for a portion of the teams milestones/deliverables.
  • Exercise positive communication techniques to maintain relationships and gain consensus in group scenarios with multiple stakeholders.
  • Promote adherence to root cause analysis and human error reduction tools

    Preferred skills:
    • Proficiency in deviation management system
    • Experience with six sigma methodologies

    QUALIFICATIONS

    A BS or MS in a scientific or engineering discipline. Minimum qualifications of BS + 4-6 yrs experience or MS + 2-4 yrs experience in a pharmaceutical and/or biological manufacturing operation with a strong technical background in a cGMP and Quality environment is required.

    PREFERRED QUALIFICATIONS

    Prior experience with investigations including conducting and writing investigations and use of continuous improve methodology preferred. The incumbent must be a collaborative team player with strong coordination, facilitation and writing skills.

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 providers 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.

  • Last Date to Apply for Job: 08.05.2019
  • Eligible for Employee Referral Bonus

1 (First Shift) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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