Pfizer Senior Associate Scientist, Compliance in Andover, Massachusetts
Work under supervision of a Scientist or higher with some degree of independence
Assist with quality control (QC) review of operational procedures performed within a large molecule bioanalytical group supporting regulated non-clinical and clinical studies to measure compound concentration, detection presence of anti-drug antibody and neutralizing anti-product antibody activity in biological matrices.
Work with colleagues within the group to review QC findings including corrective/preventative actions.
Basic understanding of the above technical capabilities is desired
Primary responsibility is to perform compliance-related (GLP, GCP) project reviews.
Gathers input from colleagues and additional resources to assist in driving the project forward
Secondary responsibility is to assist with compliance related activities required to maintain the regulated status of the bioanalytical laboratory including, but not limited to: laboratory equipment, sample management, submission-ready document preparation/formatting, and supporting clinical data processes.
Bachelor's Degree with at least 2-4 years of experience or Master's Degree with 0-2 years of experience
Successful candidate will preferably have a good understanding of or experience in the QC review of work conducted in a regulated laboratory
Knowledge and hands on experience working under GLP/GCP regulations is a plus
Industry experience with a focus in biotherapeutics is a plus
Excellent documentation and communication skills
Ability to work with tight timelines on multiple projects
Adaptability to changing work assignments and priorities
Ability to work across a matrix team
Additional Offer Details
Last Date to Apply for Job: July 26, 2018
Location: Andover, MA
Eligible for Employee Referral Bonus: Yes
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.
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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.