Scientist IV/Senior Scientist I, Formulation
- Employer
- United States Pharmacopeia
- Location
- North Bethesda, MD
- Closing date
- Nov 23, 2023
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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
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
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