U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Senior Identification & Evaluation Manager in Serilingampally Mandal, Ranga Reddy District, India

Description

Summary of the Position

The Identification & Evaluation Lead’s main responsibilities will be supporting the USP Pharmaceutical Analytical Impurities (PAI) or Materials Program product pipeline through identification and evaluation of relevant materials. In addition, the individual will be responsible for building knowledge and expertise in adjacent areas including Active Pharmaceutical Ingredients (APIs), dissolution media, physiochemistry reagents, nano materials, extractables and leachables, and more to support the introduction of new products. The individual will work collaboratively within scientific and commercial teams.

The individual will be responsible for developing and refining prioritization criteria, working closely with product management lead and others in the organization, to generate and evaluate target product lists utilizing process chemistry knowledge, collection, and review of pharmacopeial information, market information, peer reviewed publications, and patents, to determine and segment potential impurities by main manufacturing pathways. Responsibilities will also include intellectual property assessment to determine the freedom to operate.

The individual, working closely with the Director, Product Management in Rockville, will manage the list of target products, prioritization, and initiation of product development. The individual will work in a highly matrixed environment engaging with individuals across the organization including internal and external subject matter experts, marketing insights, strategic customer development, business development, and strategy to gain insight in market segments, and target customers, and develop commercial expertise in the life science space.

Roles and Responsibilities

• The primary objective is to develop and implement a process to collect data to identify impurities and associated critical materials in medicines manufacturing routes and analytical R&D related to API manufacturing routes, identify the associated impurities, and identify the most critical ones. This will include utilizing process chemistry knowledge, collection, and review of pharmacopeial information, market information, peer reviewed publications, and patents, to determine and segment potential impurities by main manufacturing pathways.

• Additional objectives are to develop broad expertise in other areas to support new product introductions that will include API reference materials, dissolution media and reagents, physiochemistry reagents, nano materials, extractables and leachables and more for potential inclusion into the materials portfolio.

• Manage chemical information in GSRS (Global Substance Registration System) and other systems.

• Develop commercial experience working closely with Product Management and commercial team in prioritizing items for inclusion in the portfolio and maximize product launches.

• Review of patents to determine the freedom to operate.

• Support comprehensive project management plans for various material segments.

• Participate in executing the change management plan.

Basic Qualifications

• Bachelor’s degree in Chemistry, or a related field, or equivalent relevant experience.

• Eight (8) years of hands-on experience as a process chemist with exposure to many APIs and diverse types of APIs and knowledge of chemical supply/value chains.

• Must be available to spend 2 weeks every quarter in Rockville, MD, USA and flexible work hours to connect with Rockville partners

Skills Sought

• Experience with handling large amounts of data and information and using scientific databases

• Experience reviewing pharmaceutical patents and patent claims.

• Experience managing projects/products in life science industry, CRO/CDMO or equivalent relevant experience.

• Excellent organizational skills and use of excel and Microsoft Office suite.

Preferred Qualifications

• Masters or PHD in life sciences

• Knowledge of business practices and the pharmaceutical industry who is adaptive, industrious, analytical, and solution-oriented

• Process and project management skills; able to manage a diverse and rapidly changing workload, delivering across several teams within a matrixed structure

• Strong presentation and communication skills

• Experience collaborating effectively with other functional groups to achieve business objectives

• Results oriented with proven ability to work with a diverse range of collaborators

• Successful relationship management skills involving multidisciplinary teams.

Supervisory Responsibilities

None at this time

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 are protected.

About 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 brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. 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.

Job Category Sales & Marketing

Job Type Full-Time

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