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Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.About ProBioProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. Job Summary: We are seeking a detail-oriented and proactive Analytical Associate Scientist or Scientist to join our US Protein Department. This role involves performing analytical testing and characterization of protein products to support research, development, and production activities. The ideal candidate will have a strong background in analytical chemistry, biochemistry, or biotechnology, with practical laboratory experience and familiarity with regulatory standards. Key Responsibilities: • Perform routine and non-routine analytical testing on protein samples using techniques such as HPLC, SDS-PAGE, ELISA, UV-Vis spectroscopy, and others as required., • Prepare reagents, standards, and samples according to established protocols., • Record, analyze, and interpret data with accuracy and integrity; prepare detailed reports and documentation., • Maintain and calibrate laboratory instruments and ensure compliance with quality standards and safety regulations., • Assist in method development, validation, and troubleshooting of analytical procedures., • Collaborate with cross-functional teams to support project timelines and deliverables., • Participate in the review and update of SOPs, batch records, and other quality documentation., • BS/MS in analytical chemistry, biochemistry, biotechnology, or related with 2+ years of relevant experience in protein purification/characterization., • Hands-on experience with analytical instruments such as HPLC, SDS-PAGE, ELISA, UV-Vis, or similar is preferred., • Strong attention to detail, organizational skills, and commitment to data integrity., • Ability to work independently and collaboratively in a fast-paced team environment., • Good communication skills and the ability to clearly document and present data., • Experience working in a CRO or CDMO setting is an advantage. #GS GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionObjectivePerspective Therapeutics is seeking a highly motivated hands-on scientist with expertise in sterile injectable drug products to join our dynamic CMC drug product team. This role is critical in supporting the development of sterile injectable formulations and drug product process development from early development through scale-up and commercial manufacturing. The successful candidate will play a pivotal role in developing and optimizing injectable radiopharmaceutical formulations and associated manufacturing processes in a cGMP-compliant environment. Working in a fast-paced, integrated, and multidisciplinary environment, the successful candidate is expected to collaborate cross-functionally while also delivering strong independent contributions that support product advancement to late-stage clinical development and commercialization.Objective • Serve as the technical subject matter expert (SME) for formulation and drug product process development., • Conduct formulation/process development studies, including comparability, stability, and compatibility assessments., • Lead scale-up and technology transfer activities to support manufacturing., • Draft detailed study plans to ensure that work is performed efficiently and in a scientifically sound manner, • Monitor experiments (e.g. process development, formulation optimization) and ensure complex data are interpreted in a scientifically correct way, • Support filter and container closure integrity validation studies and other special studies as necessary., • Collaborate with cross-functional teams including Analytical, Quality, Regulatory, and Manufacturing., • Author formulation and process development reports, study protocols, and regulatory CMC module 3 documentation to support late-stage IND and NDA submissions., • Ensure all work is performed in accordance with company policies, procedures and safety standards., • Ensure documents follow relevant regulatory standards (e.g., FDA, USP, ICH) and CMC guidelines., • Troubleshoot and propose scientifically sound solutions in collaboration with internal teams., • Provide technical support during regulatory inspections and audits, as needed.QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.Education/Experience, • Ph.D. or M.S. or B.S. in Pharmaceutics, Chemistry, or related field, • 5-7 years of hands-on experience in formulation development and sterile drug product process development using quality by design (QbD) principles., • Strong understanding of aseptic processing, formulation characterization, excipient compatibility, and container-closure systems, • Experience with QbD principles and risk-based development approaches., • Pharmaceutical product life cycle management, • Deep expertise in regulatory frameworks (FDA, EMA), and clinical/commercial manufacturing., • Familiarity with GMP quality systems and electronic document management systems., • Experience in radiopharmaceuticals or isotope-based therapeutics is strongly preferred.Knowledge / Skill / Ability, • Ability to prepare detailed study protocols and interpret complex data sets across multiple techniques., • Excellent communication skills, including the ability to explain technical concepts to cross-functional teams., • Prior radiochemistry experience and knowledge of radioactive material handling are a plus., • Strong organizational skills, with the ability to manage multiple priorities and meet tight deadlines., • Work independently and proactively in a highly matrixed environment.Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions., • Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels., • May be required to sit or stand for long periods of 8+ hours a day while performing duties., • Willingness to complete safety training within allotted time limits, and work in a team-based environment., • May require travel to Iowa up to 10%. Powered by JazzHR WawpTpaAzu