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Sr. Principal Scientist


Pearl River, NY
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Job Details


The candidate must have a good understanding of Vaccine based analytical control strategies, regulatory expectations, and their implementation. In this role the individual will work across lines to develop and implement sound analytical control strategies, which requires that he/she have a solid understanding of what is required for release and stability of Vaccine candidates. The candidate must have excellent communication skills as they will be expected to engage senior management to inform and resolve technical or logistical issues, as well as serve on multi-departmental, cross functional teams for vaccine programs under development. The incumbent will provide direct laboratory supervision and oversee the daily activities, prioritization, design, and interpretation of studies to support the development, qualification, and transfer in support of early GLP vaccine toxicology studies.


+ To develop appropriate Vaccine drug substance and drug product analytical control strategies that are aligned with program and regulatory expectations. They should be able to gain consensus from key stakeholders

+ To provide technical and scientific leadership and represent analytical development on cross functional and cross- departmental program level teams.

+ To develop assay, qualification, and transfer timelines which align with the program timelines. Track all deliverables; ensure all technical issues are resolved and that all timelines are met by effectively prioritizing activities and resources.

+ Collaborate as necessary with appropriate leaders/scientists within Vaccines and across other departments

+ The individual will manage a group of scientists within the GLP Analytical Development group within Vaccine Research and Development which has a focus on qualifying assays using the ICH guidelines and providing routine assay and stability for a range antigens (including viruses, proteins, and conjugates) used in vaccines under development. There will be some method development and assay transfers required. Primary methodologies include separation-based techniques, and other standard analytical assays.

+ The individual is expected to supervise assigned staff including setting objectives, performance management, and career development. Ensure that the staff has received appropriate training and that the training is current. Provide work assignments to direct reports on a regular basis. Manage and assist reporting scientists in the prioritization of of assignments. Identify appropriate scientific meetings/training workshops for direct reports.

+ Write and review technical documents to support assay development, qualification, and transfer.

+ Keep abreast of scientific/ technological developments by participating in scientific meetings/ seminars and through regular scientific review. Present experimental results at group meetings, project meetings and department meetings. Participate in scientific discussion with colleagues through internal journal clubs, as well as informal and formal scientific seminars and meetings.

+ Manage daily, weekly, and monthly laboratory activities, such as monitoring of equipment, completion, and review of equipment logbooks, periodic laboratory cleaning and managing the laboratory waste, checking PMO status of lab equipment and resolving discrepancies. Manage storage of reagents and test solutions in accordance with departmental procedures.


+ A Ph.D. and at least 10 years of academic, pharmaceutical, or biotechnology experience is necessary. A strong background in assay development, the ICH guidelines, and regulatory expectations are essential.

+ Knowledge and skills in analytical and bioanalytical method development and characterization for biomolecules and viral-based entities using a range of analytical and bioassay techniques.

+ Experience working with vaccines and viruses is desired

+ Good verbal and written communication skills are required.

+ Experience with directly managing reporting staff is highly desirable.

**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.

**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.

**Other Job Details:**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus

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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