Associate II-BTx PS ARD Reg Support

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The qualified candidate will join the Analytical R&D support team under GRS and contribute to the development of biological therapeutic candidates through…

The qualified candidate will join the Analytical R&D support team under GRS and contribute to the development of biological therapeutic candidates through innovation and delivery of cutting-edge analytical science. The qualified candidate will primarily perform activities pertaining to the review and approval of validation related documents as a part of an organization that focuses on method validation and transfer of analytical methods and technologies for biological therapeutics. The group is responsible for the validation and late-stage analytical lifecycle management of quality-controlled methods as they are established in commercial manufacturing sites. Qualified candidates will deliver results in a fast-paced matrix-oriented setting and be a contributor to method validations and transfers. 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. Functions at an individual contributor level to support Pfizer portfolio for the ARD 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 gain a systematic understanding of analytical methods including HPLC, CGE, iCE, PCR, ELISA, and other relevant assays applied to the QC testing of biotherapeutics and vaccines. 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. Documentation of analytical results in regulated systems is required.

QUALIFICATIONS / SKILLS Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.

• Preferred Education:

Bachelors degree in analytical chemistry, biochemistry, biology immunology, molecular biology, or related field is required with laboratory experience (preferably GMP) or Masters degree in analytical chemistry, biochemistry, biology immunology, molecular biology or related field

• Preferred Experience:

Minimum of 1-4 years of experience in an analytical laboratory experience in a variety of laboratory techniques is required. Working knowledge of interpreting analytical outcomes such a reading a chromatogram is highly desirable. Prior exposure (directly or indirectly) to regulatory documentation such as method validation reports, analytical sections of eCTD are highly desirable.

• Preferred Attributes:

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. Work Location Assignment: Flexible
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Regulatory Affairs #LI-PFE Information :

• Company : Pfizer
• Position : Associate II-BTx PS ARD Reg Support
• Location : Chennai, Tamil Nadu
• Country : IN

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