Associate Manager II – BTx PS ARD Regulatory Support

2 weeks ago

chennai, India Pfizer Full time

The successful applicant will become part of the Analytical R&D support team within GRS, playing a key role in advancing biological therapeutic candidates by applying innovative and leading-edge analytical science. The main responsibilities will include reviewing and endorsing validation-related documents within an organization dedicated to the validation and transfer of analytical methods and technologies for biological therapeutics. This team is tasked with validating and managing the analytical lifecycle of quality control methods as they are implemented in commercial production facilities. The successful candidate will thrive in a dynamic, matrix-driven environment, contributing to method validations and transfers. This position supports the development of products and processes for biotherapeutics and vaccines, such as antibodies, antibody-drug conjugates, and therapeutic proteins, during the late stages of clinical trials.

The role functions at the individual contributor level, supporting the Pfizer portfolio within the ARD business of Pfizer Biotherapeutics PharmSci.

Applicants should possess a solid foundation in laboratory operations and scientific principles. They will engage in content review and data verification for validation reports and related documents. Candidates must have a systematic understanding of analytical methods, including HPLC, CGE, iCE, PCR, ELISA, and other assays relevant to QC testing of biotherapeutics and vaccines. The individual should be capable of effective interaction with peers and leaders within a multi-disciplinary team and must excel in a fast-paced, matrixed environment. The colleague is expected to take accountability and lead projects, providing occasional mentorship to junior or entry-level team members. A keen attention to detail, strong organizational abilities, multitasking skills, and proficient interpersonal and communication skills are essential. Documentation of analytical results in regulated systems is also a requirement.

QUALIFICATIONS / SKILLS

List the qualifications and skills essential for fulfilling responsibilities, which include education, pertinent experience, licenses, certifications, and other job-related technical and managerial abilities.

Preferred Education:

A Bachelor's degree in analytical chemistry, biochemistry, biology, immunology, molecular biology, or a related discipline is necessary, as well as laboratory experience, ideally within a GMP-compliant environment.

A Master's degree or PhD in analytical chemistry, biochemistry, biology, immunology, molecular biology, or a related field

Preferred Experience:

A minimum of 5-8 years of experience in an analytical laboratory, with proficiency in various laboratory techniques, is required. 

A working knowledge of interpreting analytical results, such as reading chromatograms, is highly desirable.

Experience in working with or troubleshooting within an analytical GMP environment is highly preferred.

Previous experience, whether direct or indirect, with regulatory documentation, including method validation reports and the analytical sections of eCTD, is required.

Preferred Attributes:

Proficient in both oral and written English communication. Possesses strong conceptual, analytical, problem-solving, and organizational skills. Exhibits a positive "can do" attitude with a sense of urgency to accomplish tasks. Capable of making decisions to resolve moderately complex issues in standard scenarios. Able to make lower-level decisions within established guidelines, policies, and procedures. Works independently in ambiguous situations and effectively collaborates as part of a team. Previous experience in a cross-cultural environment and in GLP/GMP settings. In-depth knowledge of large molecules such as fusion proteins, monoclonal antibodies (mAbs), and Antibody-Drug Conjugates (ADCs). Experience with Laboratory Information Management Systems (LIMS) is essential. Familiarity with ICH guidelines is also necessary.
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.

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