USP Scientist Job For PhD Biological Sciences, Biochemistry – Apply Online

USP Scientist Job For PhD Biological Sciences, Biochemistry – Apply Online

USP Scientist Job For PhD Biological Sciences, Biochemistry – Apply Online. PhD Biological Sciences, Biochemistry Senior scientist jobs. Interested and eligible applicants can check out all of the details on the same below

Possible Interview Questions for the Senior Scientist I – Doc Standard Role are posted below

Senior Scientist I – Doc Standard

Location: Hyderabad, India

Description

Brief Job Overview

This is a hands-on, non-supervisory, non-laboratory role in the India Biologics department. The incumbent will support the reference standard program within the Global Biologics department. The incumbent in this role will focus on supporting the suitability program, including preparing and reviewing CSU testing protocols, providing technical assistance to testing labs, reviewing analytical data and preparing summary reports to assist in confirming the continued suitability of USP Reference Standards (RS). The incumbent will also participate in the development of replacement and new reference standards in support of USP’s Mission and core business.

How will YOU create an impact here at USP?

• Oversees and facilitates the development of standards and solutions to address analytical challenges associated with biological medicines.
• Supports day to day operations of the Stability program covering the USP Biologics RS catalog inventory.
• Reviews testing history and drafts test protocols for lab submission based off designated testing requirements and schedules.
• Assists laboratories to ensure testing is completed accurately and in timely manner.
• Reviews laboratory reports, evaluates results and compares to previous data and RS attributes to assess and conclude on RS suitability for use.
• Compiles current and historical data and summary assessment into Stability testing and trending reports.
• Maintains and updates various databases documenting laboratory data and program determinations on suitability and Stability interval updates.
• Supports the RS Laboratory, Quality Assurance and Reference Standard Evaluation with investigation of unexpected stability testing results.
• Works collaboratively with various USP departments as needed on test planning, data impact assessments and appropriate determination of next steps.
• Reviews protocols and/or reports of other Scientists as assigned by manager.
• Responds to stakeholder inquiries pertaining reference standards.

Who USP is Looking For?

• The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
• Ph.D. degree in Biochemistry, Analytical Chemistry or Biological Sciences. Minimum of five (5) years of post-educational work experience in recombinant therapeutic proteins, peptides and carbohydrates.
• MSc. in Biochemistry, or Biological Sciences with minimum of 10 years of commensurate industrial experience.
• Hands-on experience with analytical techniques of recombinant therapeutic proteins, peptides, and carbohydrates, such as HPLC, CE, cIEF, SEC MALS, IC and CD
• Ability to write technical reports related to material characterization, references standard evaluations, and method development.

Additional Desired Preferences

• Experience with analytical techniques of recombinant therapeutic proteins, peptides, and carbohydrates, such as LC-MS,ELISA, SPR an advanced PCR technology.
• Experience in method development and characterization of products and impurities using a variety of physicochemical techniques and biological assays.
• Excellent technical writing and oral communication skills required.
• Must be able to communicate effectively with both internal and external customers.
• Knowledge of USP products and services highly desirable.
• Operates collaboratively at all levels of the organization in a highly technical environment.
• Must be able to work in a fast-paced environment and respond to shifting priorities.
• Well-developed interpersonal, negotiation and listening skills.
• Must possess the ability to multi-task and to work effectively with a team.
• Takes personal responsibility to ensure work is delivered on time and is of the highest possible quality.
• Experience working in the compendial, pharmaceutical and/or biotechnology industry strongly preferred.

Supervisory Responsibilities: None

• USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected..
• COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired:
• As a condition of employment with the United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
• USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
• Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under a specific written agreement with USP.

Job Category: Chemistry & Scientific Standards

Job Type: Full-Time

APPLY ONLINE

Possible Interview Questions for the Senior Scientist I – Doc Standard Role:

1. Can you describe your experience with analytical techniques for recombinant therapeutic proteins, peptides, and carbohydrates? Which specific techniques have you worked with, and what were your responsibilities in using these techniques?

Answer: During my tenure, I have gained hands-on experience with several analytical techniques, including HPLC, CE, cIEF, SEC MALS, IC, and CD. I have been responsible for utilizing these techniques to analyze and characterize recombinant therapeutic proteins, peptides, and carbohydrates, ensuring their quality and suitability for use.

2. How have you contributed to the development and maintenance of reference standards in your previous role? Can you provide an example of a project where you played a significant role in ensuring the suitability and stability of reference standards?

Answer: In my previous role, I actively participated in the development and maintenance of reference standards. For example, I collaborated with testing labs to draft test protocols based on designated requirements and schedules. I reviewed laboratory reports, evaluated results, compared them to previous data and reference standard attributes, and assessed their suitability for use. I also compiled comprehensive stability testing and trending reports, incorporating current and historical data.

3. Have you been involved in method development and characterization of products and impurities? If so, can you describe your experience and the techniques you utilized?

Answer: Yes, I have been extensively involved in method development and characterization of products and impurities. I have utilized a range of physicochemical techniques and biological assays to ensure thorough characterization. These techniques include LC-MS, ELISA, SPR, and advanced PCR technology, enabling comprehensive analysis and assessment of product quality.

4. How do you ensure effective communication and collaboration with internal and external stakeholders in a highly technical environment? Can you provide an example of a challenging situation you encountered and how you resolved it?

Answer: Effective communication is crucial in a highly technical environment. I prioritize active listening and clear, concise communication to ensure alignment and understanding. In a previous project, I encountered a situation where there were conflicting interpretations of analytical results between internal and external stakeholders. I facilitated open discussions, organized meetings to address concerns, and encouraged collaborative problem-solving. By fostering an environment of open communication and mutual respect, we were able to resolve the conflicts and reach a consensus.

5. Can you discuss your experience with writing technical reports related to material characterization, reference standard evaluations, and method development? What elements do you consider essential in creating high-quality technical reports?

Answer: Throughout my career, I have developed strong skills in writing technical reports. I understand the importance of clear and concise communication while maintaining accuracy and attention to detail. In my reports, I ensure a comprehensive overview of the material characterization process, reference standard evaluations, and method development, providing all relevant data and analysis. Additionally, I emphasize the significance of data interpretation and the implications for product quality and regulatory compliance.

Note: The answers provided are sample responses and can be modified and tailored based on the candidate’s actual experience and expertise.

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