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Senior Scientist, Large Molecule Bioanalytics

Pfizer

This is a Contract position in Andover, MA posted October 8, 2020.

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