The qualified candidate will join the Bioprocess R&D support team under GRS and contribute to the development of biological therapeutic candidates through innovation and delivery of cutting-edge bioprocess sciences. The qualified candidate will primarily perform activities pertaining to the review and approval of bioprocess development related documents as a part of an organization that focuses on purification process development for biotherapeutics. Qualified candidates will deliver results in a fast-paced matrix-oriented setting and be a contributor to documentation around bioprocess development. The role is in support of products and process development for biotherapeutics and vaccines, including antibodies, antibody-drug conjugates, and therapeutic proteins, in late-stage clinical development.
What You Will Achieve
In this role, you will:
Functions at an individual contributor level to support Pfizer portfolio for the BRD business of Pfizer Biotherapeutics PharmSci.
Candidate should have a good foundation of laboratory operations and scientific principles. They will be involved in the content review of and verification of data for validation reports, and related documents.
The candidate is expected to possess a theoretical understanding of purification techniques such as Pro A, viral filtration, and tangential flow filtration. A practical experience of these techniques is highly desirable. The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team. The candidate must thrive in a fast-paced matrixed environment.
Attention to detail, strong organizational skills, the ability to multitask and effective interpersonal and communication skills are required.
Here Is What You Need (Minimum Requirements)
Bachelor's or Master's degree in bioprocess technology, analytical chemistry, biochemistry, biology immunology, molecular biology, or related field or
Bonus Points If You Have (Preferred Requirements)
Minimum of 8-10 years of experience in a bioprocess laboratory in a variety of laboratory techniques is required.
Working knowledge of interpreting analytical outcomes such a reading a chromatogram, basics of purification techniques are highly desirable
Prior exposure (directly or indirectly) to regulatory documentation such as process development reports, lab performance qualification reports, validation reports, and relevant sections of eCTD are highly desirable.
Good oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills.
Positive “can do” attitude, and a sense of urgency to get things done. Can makes decisions to resolve moderately complex problems in standard situations.
Makes smaller level decisions within guidelines, policies & procedures.
Can work independently in ambiguous situations as part of a work team.
Prior working experience in a cross-cultural set-up as well as a GLP/GMP set up
Strong understanding of large molecules (fusion proteins, mAbs, ADCs)
Work experience with LIMS is highly desirable
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.