Senior Scientist I, Documentary Standards(Biologics)

Who is USP

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds top authorities in health and science to develop quality standards for medicines dietary supplements and food ingredients. USPs fundamental belief that Equity Excellence manifests in our core value of Passion for Quality through our more than 1300 hardworking professionals across twenty global locations to deliver the mission to strengthen the supply of safe quality medicines and supplements worldwide.

At USP we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create the partnerships we build and the conversations we foster we affirm the value of Diversity Equity Inclusion and Belonging in building a world where everyone can be confident of quality in health and healthcare.

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 workan environment where every employee feels fully empowered and valued irrespective of but not limited to 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.

Brief Job Overview

This is a handson nonsupervisory nonlaboratory role in the India Biologics department. The incumbent work collaboratively in the reference standard/ARM development program within the Global Biologics department. The incumbent will participate in the development of replacement and new reference standards /ARM in support of USPs mission and core business. The incumbent will also 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 need to be excellent team player with good collaboration/Liaising skills to complete assigned projects in timely manner.

How will YOU create impact here at USP

In this role at USP you contribute to USPs public health mission of increasing equitable access to highquality safe medicine and improving global health through public standards and related programs. In addition as part of our commitment to our employees Global People and Culture in partnership with the Equity Office regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.

The Sr. Scientist I (RSS) has the following responsibilities:

Roles and Responsibilities

• Maintain smooth collaboration and works closely with key stakeholders across the globe to develop reference standards for biotechnology pharmaceutical products including proteins peptides heparins antibiotics and advanced therapies.
• Works to draft protocols reports and address scientific and technical queries from internal and external stakeholders in timely manner pertaining to reference standards/ARMs
• 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 (CSU) program covering the USP Biologics RS catalog inventory.
• Reviews RS testing history and drafts test protocols for collaborative studies and CSU studies and submits to labs based on designated testing requirements and schedules.
• Liaisons and Assists laboratories to ensure collaborative testing/CSU 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 Stability testing data assessment and prepare stability trend reports.
• Maintains and updates various databases documenting laboratory data and program determinations on suitability and Stability interval updates.
• Filing and closure of QMS elements as per QMS system when required and 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.
• Prepare present and discuss regular work updates with Team Lead and other team members
• Reviews protocols and/or reports of other Scientists as assigned by manager.

Who is USP 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:

Preferred Qualifications

• Handson experience with stateoftheart analytical techniques for the characterization of recombinant therapeutic proteins peptides gene therapy vaccines and carbohydrates such as UPLC/HPLC LCMS CD Fluorescence spectroscopy FTIR DSC SECMALS CESDS (Reducing and Nonreducing) icIEF ELISA SPR ddPCR/qPCR etc.
• Strong ability to evaluate and compile analytical testing data ability to write technical reports related to material characterization references standard evaluations and method development.
• Demonstrated experience in analytical method development method qualification/validation and characterization of biological products and impurities using a variety of physicochemical techniques and biological assays.

• Excellent technical writing presentation and oral communication skills are required.

• Must be excellent team player and able to work amicably and communicate effectively with both internal and external stakeholders.

Sr. Scientist I

• Ph.D. degree in Biochemistry Analytical Chemistry or Biological Sciences . Minimum of 7 to 10 years of posteducational work experience in recombinant therapeutic proteins peptides and carbohydrates.
• in Biochemistry or Biological Sciences with minimum of 11 to 13 years of commensurate industrial experience.

Additional Desired Preferences

• Knowledge of USP products and services is highly desirable.
• Operates collaboratively at all levels of the organization in a highly technical environment.
• Must be able to work in a fastpaced environment and respond to shifting priorities.
• Welldeveloped interpersonal negotiation conflictresolution and listening skills.
• Must possess the ability to multitask and to work effectively with a team.
• Takes ownership and 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

No

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From companypaid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial wellbeing is protected.

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 specificwritten agreement with USP.

Required Experience:

Senior IC