Associate Manager II- BTxPS BRD Reg Support

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)

• Bachelors or Masters 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