Job Description:
Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies.
Review master batch records (MBR), Master Packaging Work Orders (MPWO), and clinical related supplies-related documents.
Assist and support the review of packaging, labeling, storage, logistics, and distribution documentation of the investigational product.
Assist and support the management of clinical supply inventories using Interactive Response Technology.
Expected to prepare data tables when needed for data interpretation.
Assist with documentation and process internal and external change controls.
Assist and support clinical supply activities for investigational products, such as import and export, customs clearance, DEA Controlled Drug experiences, etc.
Manage and processing of CMC Team project invoices and internal project budget requests (ARIBA), and monitoring of project financial tracking.
Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global).
Assist and support the Quality Assurance Unit (QAU) regarding the review of investigations and conduct vendors and internal audits.
Assist and support Clinical Operations on document reviews related to the study specifics, such as pharmacy manual, study protocols, investigational brochures, etc.
Preferred Experience:
Bachelor’s in chemistry (preferred analytical) degree up to 5-8 years of experience working in an analytical laboratory background
Ability to read, analyze, and interpret basic scientific protocols, reports, and technical journals. Also, should be able to interpret financial reports.
Expert technical skills, good organization skills, ability to follow directions, and good communication skills. Computer aptitude is a plus, especially proficiency with Microsoft Office, and in particular use of Excel and the ability to plot data.
Understand protocols, write SOPs, and have technical knowledge of packaging and labeling activities.
Knowledge of pharmaceutical stability protocols, assessment of expiration dating for investigational drug products
Knowledge of GMP batch record development, review, and approval process
Demonstrated understanding of the entire supply chain and associated cost drivers
Ability to execute the Clinical Supply portion of User Acceptance Testing (UAT) for the IRT system.
Knowledge of GCP and global cGMP regulations, (knowledge of EU GMP QP regulations is preferred), a plus.
Knowledge of warehousing, distribution (including cold chain distribution), and logistics, a plus.
Ability to review, analyze, and interpret the IVR/IRT reports and specification requirements, a plus.
Ability to understand, maintain, and demonstrate troubleshooting on vendor’s IRT/IVRS system, a plus.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.