Job Description

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Operating from two U.S.-based manufacturing facilities, Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

This role will support the transfer of client processes and technology in the Development space with the intent to enter our GMP facility, executing upstream and downstream processing, process optimization, and troubleshooting. They will conduct process and analytical testing, transfer processes for phase appropriate manufacturing and collaborate on cross-functional projects. Strong skills in experimental design, data analysis, and communication are essential. The role also involves maintaining customer relationships, supporting MSAT activities with Project Managers, and contributing to the creation of key documentation, including SOPs and Batch Records, to ensure smooth process execution.

This role will be primarily located in Princeton, NJ, fully onsite. However, the project responsibilities will require periodic travel to our other facility located in Newark, NJ (30%).

Key Responsibilities

• Strong Chemistry, Manufacturing, and Controls (CMC) knowledge in alignment with FDA regulations and remaining compliant with evolving regulations

• Knowledge of navigating the drug development process in terms of IND filings, NDA, amendments, and BLAs

• Ability to review, draft, and update CMC sections of IND filings

• Experience with FMEAs, gap assessments, APS and batch record authoring, process monitoring, and process improvements

• Design of manufacturing and test methods that endure drug safety, quality, and efficacy

• Assist with the assessment of client process, analytical, and material readiness for technology transfer activities into our GMP facility.

• Hands-on execution of the various aspects of processing and analytical activities to support small-scale studies and process scale-up.

• Design experiments for process optimization and troubleshooting.

• Implement solutions to technical issues and participate in continuous improvement activities.

• Complete analytical testing for development and technology transfer activities

• Extensive experience with experimental design, data analysis, organization, lifecycle management, and presentation of complex scientific concepts.

• Transfer processes from Development lab to the GMP facility for phase appropriate manufacture (early stage required, late stage preferred).

• Conduct work cross-functionally on a variety of projects.

• Communicate effectively with internal and external stakeholders, with ability to provide ad hoc clarification as needed.

• A high level of competence, integrity and communication

• Cleaning, organization, and residential maintenance of the laboratories as an active member executing experiments in the laboratory (e.g., weekly clean, inventory, etc.)

• Support creation of documents required for new process execution in Operations, SOPs, Batch Records, Specifications, Qualification and Validation requirements, etc.

• Performed other duties as assigned by Head of MSAT.

Required Qualifications

• Knowledge of cell and gene therapy manufacturing concepts.

• A safety-first mindset and diligent adherence to safety requirements.

• An ability to execute tasks independently with oversight of management.

• Ability to work effectively in a team environment

• Strong verbal and written communication skills interdepartmentally and cross-functionally

• Enjoys working in a dynamic, fast-paced environment and possesses transparency in their communication skills.

• The candidate should be a self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment.

• Aseptic processing technique.

• Strong Chemistry, Manufacturing, and Controls (CMC) knowledge in alignment with FDA regulations and remaining compliant with evolving regulations

• Knowledge of navigating the drug development process in terms of IND filings, NDA, amendments, and BLAs

Preferred Qualifications

• Experience working in a GMP environment.

• Experience working within a CDMO environment, and/or maintaining customer relationships.

• Experience with analytical assays (e.g. flow cytometry, ELISA, cell counts, PCR).

Required Degree(s)

• Degree in Molecular Biology, Chemical, Biochemical, or Biological Engineering, Biochemistry, Biotechnology, or an equivalent field with at least 1-4 years (Ph.D.), 2-5 years (M.S.), or 5-8 years (B.S.) of relevant industry experience.

Physical Requirements

• Ability to perform the essential job functions consistent safely and successfully with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.

• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state, and local standards.

• Must be willing to be gown qualified and work in BSL-2 lab/CNC/ISO7/ISO8 facility.

• Must be able to lift and carry up to 30 lbs.

• Must be willing to bend, stoop, carry, reach, climb or stand on an elevated bench or step stool.

• Must be willing to sit or stand for extended periods.

• Must be willing to work with cell-based products, chemicals or hazardous materials.

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