Job Description

ROLE SUMMARY

* Responsible for the development of robust and reliable bioanalytical assays suitable for the quantitation of biotherapeutics in various biological matrices using ligand-binding, cell-based and/or PCR methodologies.
* Responsible for the development robust and reliable ligand binding assay and /or cell-based assays suitable for characterizing the immunogenicity of biotherapeutics in various biological matrices using a range of potential platforms and assay techniques.
* Validation and implementation of assays to be governed per departmental SOPs and GLP / GCP regulations
* Lead and collaborate with other colleagues in a matrixed team environment.
* Advancing bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assay for regulated support.

ROLE RESPONSIBILITIES

* Design, develop and implement ligand-binding and cell-based assays using different platforms (e.g. ELISA, ECL, Gyros) in biological matrix (plasma, serum) to measure compound concentration, detect the presence of anti-drug antibody and neutralizing anti-product antibody activity in a regulated (GLP, GCP) environment against challenging time lines.
* As appropriate, participate in the establishment of PCR methods to support gene therapy programs.
* High degree of independence in the design, trouble shooting, validation and conduct of the assay to support biotherapeutic programs.
* Collaborate with inter-departmental partners to ensure that bioanalytical methods meet scientific requirements for support of clinical and nonclinical studies.
* Timely delivery of concentration and immunogenicity data to inter-departmental partners in compliance with local or global regulatory requirement
* Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making.
* Supervise the activities of junior staff members, guiding them in the design and interpretation of experiments.
* Authors reports and protocols, and presents findings to peers and management as required.

Qualifications

BASIC QUALIFICATIONS

* BS in a relevant discipline, with 9+ years of bioanalytical laboratory experience, or MS degree with 6+ years experience or PhD with 3+ years experience.
* Demonstrated skills in ligand-binding assay development.
* Excellent communication and presentation skills

PREFERRED QUALIFICATIONS

* Experience in cell culture and bioassay techniques
* Knowledge and exposure to PCR and other molecular biological techniques
* Knowledge and experience working in a regulated environment

Other Details:

- Eligible for Employee Referral Bonus: Yes

- Eligible for Relocation Package: No

LI-PFE

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.

Research and Development

LI-PFE