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Scientist IV/Senior Scientist I, Formulation

Employer
United States Pharmacopeia
Location
Rockville, MD
Start date
Nov 20, 2023

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Discipline
Science/R&D, Biotechnology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital, Best Places to Work

Job Details

Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

Brief Job Overview

This position is a non-supervisory position responsible for developing specific materials to be used to assess suitability and performance of various release testing apparatuses. This work requires extensive knowledge as a formulation scientist with expertise in pharmaceutical manufacturing and in dosage form design, performance testing (i.e., physical and biopharmaceutical properties, e.g., dissolution/drug release), as well as a full application of sound scientific principles, theories, concepts, and techniques. The incumbent is expected to design research protocols, collect appropriate product characterization data, and develop solutions for unique research and development projects related to compendial and non-compendial testing of finished dosage forms.

How will YOU create impact here at USP?

Works independently to develop reference standard materials used to the determine the suitability of testing equipment used to characterize the performance of finished pharmaceutical dosage forms.

Develops formulation at a small scale and understands scale up requirements.

Develops processes for manufacturing of solid, modified release, semi-solid or other dosage forms applying sound quality by design principles.

Conducts research into processes and techniques of relevance to pharmaceutical dosage form manufacturing to understand the functional relationships among formulation composition, process parameters, material characteristics and product performance.

Responsible for managing tech transfer projects for contract manufacturing projects.

Has knowledge of and ability to perform experimental activities required to support the formulation development work to characterize the properties of the formulation physical parameters such as assay, content uniformity, dissolution testing, hardness, friability, etc.

Performs other investigations in the lab, as needed.

Interprets generated data with little or no assistance; explains results to others.

Troubleshoots common manufacturing process challenges independently and identifies risks early in the process.

Utilizes routine and non-routine instrumental methods to identify superior formulation and investigate formulation issues.

Coordinates activities among the team members and communicates results of work clearly to team and management.

Prepares and presents oral and written reports to team, department, or other USP stakeholders.

Trains and mentors less experienced staff in various aspects of research and dosage form characterization techniques.

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:

Scientist IV

Ph.D, M.S, or B.S. in Pharmaceutical Science, Material Science/Engineering or other closely related science.

At least 2 years with Ph.D. or 5 years with M.S, or 8 years with B.S. of work experience in pharmaceutical manufacturing. Experience in pharmaceutical production, development or other activities related to pharmaceutical drug product development is required.

Experience in the cGMP and/or ISO requirements for pharmaceutical testing and manufacturing organizations.

Familiarity/hands-on experience in analytical and material characterization techniques such as UV-Vis analysis, HPLC, finished product assay and performance/stability characterization. Working knowledge of MS Office software is required.

Senior Scientist I

Ph.D. or M.S. in Pharmaceutical Science, Material Science/Engineering or other closely related science.

At least 5 years with Ph.D. or 7 years with M.S. of work experience in pharmaceutical manufacturing. Experience in pharmaceutical production, development or other activities related to pharmaceutical drug product development is required.

Experience in the cGMP and/or ISO requirements for pharmaceutical testing and manufacturing organizations.

Familiarity/hands-on experience in analytical and material characterization techniques such as UV-Vis analysis, HPLC, finished product assay and performance/stability characterization. Working knowledge of MS Office software is required.

Additional Desired Preferences

Must have the capability to plan and conduct research independently.

Familiarity with the cGMP and/or ISO requirements for pharmaceutical testing and manufacturing organizations.

Research experience in dosage form characterization and in vitro testing is required.

Project management experience.

Excellent communication and presentation skills, both verbal and written.

Proficient with drug release and product testing involving compendial methods (USP, BP, EP, etc.).

Takes personal responsibility to ensure work is delivered on time and is of the highest quality.

Skilled in anticipating, troubleshooting, and solving technical problems.

Ability to build technical expertise in others by serving as a mentor and positive influence on the team.

Possesses experience and a proven track record of introducing new or innovative technologies into the laboratory.

Proven analytical and multi-tasking abilities.

Familiarity with advanced manufacturing techniques, design of experiments and QbD principles.

Supervisory Responsibilities

None.

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing 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 workfrom 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 specific written agreement with USP.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)

Job Category Chemistry & Scientific Standards

Job Type Full-Time

Company

USP is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected. We do this through establishing public scientific standards and programs that help ensure billons of people around the world have access to safe and quality products.

USP aspires to be a diverse, inclusive, innovative, and engaging organization that empowers and engages staff and volunteers to contribute to its mission to improve global health. We are committed to creating a culture 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, family status, and where they can contribute their full potential to accomplish our mission.

At USP, you’ll join a talented and diverse team of 1,200 scientific, technical and public health professions, working in state-of-the-art facilities and collaborating with the world’s leading experts from industry, academia, healthcare, and government to address public health challenges and advance cutting-edge innovation.

Whether you’re helping to establish new USP standards, creating key resources to address emerging health issues, or providing critical technical assistance in the developing countries, you’ll be inspired by the positive impact your work has on building public trust and a healthier tomorrow.

Company info
Website
Location
12601 Twinbrook Parkway
Rockville
Maryland
20852
United States

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