U.S. Pharmacopeial Convention (USP) Hiring For the Post of Scientist III, Microbiology (Biologics)

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

Job Title : Scientist III, Microbiology (Biologics)

Tracking Code : 733-679

Job Description :

This is a hands-on, non-supervisory position in the Microbiology laboratory of USP-India’s Biologics Department. Conducts lab test procedures for Verification Program and actively participates in the routine daily activities and audits. Responsible for independent execution of project tasks and submission of reports.

Roles and Responsibilities:

• Demonstrates strong skills and expertise in laboratory methods in the area of microbiology. The tests include but not limited to Identification, Enumeration, pathogenic tests, Sterility test, Bacterial endotoxin test, Antibiotic assays.
• Reviews, and evaluates test protocols and scientific literature and actively engages in the overall project and ensures own work is aligned with overarching goals
• Independently executes all testing / analysis , and records experimental data, ensuring clear and accurate transcription of results and calculations
• Records experimental data, ensuring clear and accurate transcription of results and calculations and prepares reports.
• Independently plans and executes experiments for project tasks assigned. Derives interpretation and conclusion of results.
• Plans daily work, records and review results and documents to ensure correctness and to fulfill targets on time.
• Completes assigned work with quality and in a timely manner. Assists the group leader in implementing laboratory procedures and systems. Coordinates with other team members as per requirement
• Prepares protocols and reports including calculations and conclusions. Prepares presentations and documents related to projects and various scientific discussions as delegated.
• Follows QMS practices. Recommends improvements to systems and all other supporting activities.
• Assists supervisor in planning, evaluating and implementing lab procedures and systems. Takes part in audits as per delegation.
• Follows and ensures aspects related to safety, ethics and legal compliance.
• Performs in-charge duties for the allocated lab/equipment/inventory/supporting activities and takes responsibility for the timely completion of the tasks assigned.
• Demonstrates a strong desire to continue learning, grow personal capability and willingness to learn and contribute in the relevant and other areas of Biologics.
• Pursues, recommends and implements new approaches or processes to improve laboratory operations
• Performs peer review of data as needed.
• Performs other duties as assigned.

Required Skills

• Experience in an ISO/QC environment is must.
• Good understanding of microbiology testing requirements as per different regulatory requirements such as USP, EP, ISO, FDA, AOAC is desired.
• The candidate must take personal responsibility to ensure work is delivered on time and is of the highest possible quality.
• Ability to anticipate, trouble shoot, and solve technical problems.
• Strong communication and presentation skills, both verbal and written, and experience working in the Pharma or biopharma industry is strongly preferred.

Required Experience

• Master’s degree in any life science field with not less than six years of experience in Microbiology.
• Laboratory experience must include performing the routine tests namely, Identification, Enumeration, Pathogenic test, Sterility test, BET, Antibiotic assays etc. as per the regulatory guidelines.
• Experience handling variety of samples, namely, API, food, dietary supplements, probiotics etc. and rapid or high through put methods is highly desired.

Job Location : Hyderabad, Andhra Pradesh, India

Position Type : Full-Time/Regular

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