Job Description
The manufacturing associate will provide hands-on technical support for all aspects of cGMP cell therapy manufacturing, including technology transfer, process validation, and process support. This role involves working in both team-oriented and individual environments, monitoring process performance at the contract manufacturing organization (CMO), and ensuring the successful delivery of products with regard to time, quality, and budget.
ResponsibilitiesReview and monitor cell culture and aseptic processing activities performed at CDMOs.Review and monitor GMP developmental and commercial manufacturing operations.Provide Quality Assurance (QA) with technical support for process discrepancies and deviation investigations.Plan and track domestic and international GMP and non-GMP material shipments.Assist in planning, writing, and managing the execution of cGMP manufacturing protocols, batch records, SOPs/WIs, and plans.Prepare manufacturing/campaign reports.Accountable for the integrity and tracking of cGMP manufacturing department process data.Accurately and timely manage the tracking of all cGMP material and cell bank inventories.Coordinate and track lot release testing samples.Assist with technical support for CDMO GMP manufacturing activities.Maintain cGMP cell bank and product inventories.Liaise with functional groups and sub-contractors.Report progress to supervisors and attend progress meetings regularly.Maintain familiarity with current and emerging technologies through reading scientific and technical literature.Comply with quality systems and all pertinent safety policies, rules, and regulations.Essential SkillsCell cultureAseptic processingGMPTissue cultureFlaskHyperStackCell FactoryGDPCell TherapyGene TherapyScale-UpManufacturingBiotechnology3D Cell CultureAdditional Skills & QualificationsBS or MS degree in Biology or related discipline, or an associate degree in a life science discipline.Understanding of cell and molecular biology techniques for the identification and validation of drug targets.2-5 years of biotechnology or pharmaceutical cGMP manufacturing experience, preferably in cell or gene therapy.Experience with cGMP aseptic processing and tissue culture using Flask, HyperStack, Cell Factory, and 3D cell culture is preferred.Strong interpersonal, attention to detail, communication, and organizational skills.Good documentation (GDP) and organizing skills are recommended.Self-directed and self-motivated with the ability to work both independently and as a team member in a matrix environment.Exceptional oral and written English communication skills.Work Environment
Work is performed at an office, Contract Manufacturing Organization (CMO), and contract vendor’s facility. Minimal non-standard work hours, such as evening or weekend work, will be required. Minimal travel, including international travel to the CMO Site in Singapore, may be required during cGMP manufacturing activities.
Pay and Benefits
The pay range for this position is $70000.00 - $80000.00/yr.
•\t401(k)
•\t401(k) matching
•\tDental insurance
•\tFlexible schedule
•\tHealth insurance
•\tLife insurance
•\tPaid time off
•\tReferral program
•\tVision insurance
free lunch every Monday, monthly out of office team lunch, quarterly happy hour/BBQ/Holiday Party
Workplace Type
This is a fully onsite position in Rockville,MD.
Application Deadline
This position is anticipated to close on Jun 26, 2025.
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.
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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.