The U.S. Pharmacopeial Convention (USP) Senior Scientist I - Documentary Standards in Hyderabad, India
Roles and Responsibilities
Develops strategies and processes for the elaboration of a steady pipeline of standards to support the analytical evaluation of different classes of biotherapeutics.
Develops relationships with key stakeholders from academia and industry to engage in collaborations in early pipeline development projects. Leads collaborations with academic collaborators and stakeholder groups.
Develop relationships and partnerships with key stakeholders, within the research, manufacturing, and regulatory communities
Plans and oversees necessary laboratory work for feasibility and proof of concept studies. Evaluates and analyzes scientific reports and identifies next steps and key challenges. Engages and builds relationships with internal and external laboratories to participate in round robin studies in support of feasibility and proof of concept studies.
Partners with the standards production team leads for eventual handoff leading to planning and initiation of standards development projects.
Serves as representative of USP at professional scientific meetings organized by USP and other organizations. Gives public presentations on USP matters (as assigned).
Collaborates with the biologics program unit team to gather insights based on internal and external data and perform analyses to inform on opportunities for further exploration. Communicates and maintains working relationships with other USP departments, as applicable.
Designs and oversees the execution of collaborative testing once a candidate material has been sourced. Prepares data summary and analysis from collaborative studies.
Master’s degree in Biological Sciences and ten (10) years of relevant experience in analytical development for biotherapeutics/vaccines/advanced therapies that includes at least 5 years in a regulated biopharmaceutical environment.
Experience in process development, analytical characterization, and chemistry and manufacturing control (CMC) for biotherapeutics.
An equivalent combination of experience and education may be substituted.
Strong experience in the areas of characterization and analysis of biopharmaceuticals.
Knowledge of reference standards related to biopharmaceutical products/industry. Experience with reference materials manufacturing and development is a plus.
Knowledge of national and international regulatory filings approaches. Familiarity with regulatory guidance documents from WHO, FDA, ICH and other international organizations.
Experience in method development and characterization of biological products, impurities, and raw materials using a variety of physicochemical techniques and biological assays.
Demonstrated research, technical, and analytical skills, as well as the ability to take highly technical scientific information and make recommendations.
Strong writing skills and experience drafting technical reports related to material characterization, method development and reference standard evaluation.
Expertise in analytical methods applicable to biotherapeutics, including bioassay, HPLC, capillary electrophoresis. Experience in mass spectrometry or SPR is a plus.
Experience in method development, qualification and/or validation, method transfer, and development of system suitability criteria.
Demonstrated stakeholder collaboration experience, with the ability to develop and manage internal and external relationships and contacts.
Ability to establish and nurture relationships with individuals of varying backgrounds and learning styles.
Excellent presentation and communication skills (written and oral).
Ability to communicate technical information with non-technical or non-scientific staff, and to interact effectively with representatives from pharmaceutical companies, government, and academic institutions.
Project Management skills. Must have ability to prioritize and manage multiple, concurrent projects with often long-life cycles.
Effective at operating independently where appropriate yet understands when to escalate issues and how to establish effective working relationships.
Able to perform in a fast-paced environment with changing deadlines and priorities. Ability to manage and prioritize multiple, concurrent projects.
Experience and knowledge of the USP-NF is preferred.
Job Category Chemistry & Scientific Standards
Job Type Full-Time