Senior Scientist I, Documentary Standards (Reviewer)

Description

Brief Job Overview

This is a hands-on, non-supervisory scientific position the Global Biologics department. The incumbent is responsible for providing support for the development of USP documentary standards and reference standards for biological products such as peptides, Oligonucleotides, protein, carbohydrates, Complex Biologics, Vaccines, Antibiotics, and advanced therapies. The incumbent will provide quality and technical review of scientific documents for accuracy, clarity and compliance, manage and track reference standard stability program and organize efforts for continuous process improvements. The incumbent will also focus on supporting the reference standard suitability program, including preparing and reviewing CSU testing protocols, providing technical assistance to testing labs, reviewing analytical data and preparing summary reports for 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 time-bound manner.

How will YOU create impact here at USP?

In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, 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-Review) has the following responsibilities:

Roles and Responsibilities

• Performs technical and quality reviews of documents to ensure a high level of document quality and compliance before QA review
• Manages and tracks efforts for continuous process improvements.
• Develops and reviews SOP’s, Operation Manuals, and training documents.
• Assists in investigations of quality related issues resulting from customer complaints to include root cause analysis, corrective action identification, action planning, and implementation monitoring.
• Supports the day to day operation of the reference standard stability program.
• Works with internal stakeholders to develop new and innovative standards for analytical analysis of biological products.
• Communicates and maintains working relationships with cross functional USP departments regarding assigned projects
• Supports day to day operations of the RS Stability (CSU) program covering the USP Biologics RS catalog inventory.
• Reviews RS testing history and drafts test protocols for CSU studies and submits to labs based on designated testing requirements and schedules.
• Liaisons and Assists laboratories to ensure CSU testing is completed as per protocol 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, assess current and historical stability testing data and prepare stability trend reports in a time-bound manner.
• Support the maintenance and updation of 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, Supporting Quality Assurance and Reference Standard Evaluation in the 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

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:

• PhD. degree in Biochemistry/Biology/Pharmacy, or a related field Minimum of 7 to 10 years, or Masters degree in Biochemistry/Biology/Pharmacy or a related field with 11 to13 years of years of commensurate industrial experience.
• Demonstrated experience in Techical review of analytical documents in Quality Assurance.
• Hands-on experience with state-of-the-art analytical techniques for the characterization of recombinant therapeutic proteins, peptides, gene therapy, vaccines and carbohydrates, such as UPLC/HPLC, LC-MS, CD, Fluorescence spectroscopy, FTIR, DSC, SEC-MALS, CE-SDS (Reducing and Non-reducing), 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.

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 fast-paced environment and respond to shifting priorities.
• Well-developed interpersonal, negotiation, conflict-resolution and listening skills.
• Must possess the ability to multi-task 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 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.

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 specific written agreement with USP.