Made Scientific
HR Assistant at Made Scientific | Skilled in Talent Acquisition & Employee Engagement | HR Graduate
About Made Scientific
Made Scientific is a leading U.S.-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
The Manufacturing Supervisor provides leadership to the Sterile Production Team, ensuring high-quality operations, regulatory compliance, and adherence to cGMP standards. This role oversees daily production activities, supervises cleanroom environments, and drives continuous improvement through collaboration, problem-solving, and monitoring of key performance metrics.
The position also involves developing and mentoring team members, promoting a positive and safe work culture, and ensuring consistent alignment with Made Scientific’s mission to deliver life-changing therapies.
Key Responsibilities
Provide strategic direction to the Sterile Production Team, ensuring alignment with the organization’s core values and commitment to high-quality outcomes.
Oversee sterile production operations, ensuring compliance with cGMP, regulatory requirements, and production schedules while maintaining accurate documentation, SOPs, and equipment standards.
Supervise daily operations, spending approximately 50% of time in cleanroom environments, reviewing batch records, and addressing production issues to ensure product quality and safety.
Support continuous improvement through root cause analysis, feedback, and monitoring of KPIs to improve metrics such as scrap, non-conformance, and plant efficiency.
Lead hiring, training, and performance management initiatives to build a skilled, engaged, and safety-focused team.
Foster a collaborative and compliant work culture with strong adherence to environmental, health, and safety standards.
Partner cross-functionally with Quality, Engineering, and Process Development teams to support operational alignment and improvement projects.
Perform other duties as assigned.
Required Qualifications
Bachelor’s degree in Science, Engineering, or a related field, or equivalent experience.
Minimum 4 years of operations experience within a cGMP environment in the biotech or biopharma industry.
Minimum 1 year of leadership, supervisory, or management experience (preferred).
Prior experience in manufacturing, quality, or engineering is required.
Excellent communication, leadership, and organizational skills.
Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).
Strict adherence to SOPs, GMP regulations, FDA guidance, and documentation best practices.
Preferred Qualifications
Experience with cell therapy automation technologies, closed‑system culture vessels, cell washers, and cell separation technologies for autologous/allogeneic product manipulation.
Hands‑on experience in handling, propagation, isolation, activation, and cryopreservation of human primary cells, including T cells.
Physical Requirements
Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and other applicable standards, including meeting productivity expectations.
Regular, punctual attendance is required.
Must be willing to be gown‑qualified and work in CNC/ISO8/ISO7 cleanroom environments.
Must be able to lift up to 25 lbs.
Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.
Must be able to sit or stand for extended periods.
Must be willing to work with cell‑based products, chemicals, and hazardous materials.
Work Schedule
Must be available to work weekends, holidays, and extended hours as required to meet production needs. Flexibility to accommodate changing production schedules is expected.
#J-18808-Ljbffr
Made Scientific is a leading U.S.-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
The Manufacturing Supervisor provides leadership to the Sterile Production Team, ensuring high-quality operations, regulatory compliance, and adherence to cGMP standards. This role oversees daily production activities, supervises cleanroom environments, and drives continuous improvement through collaboration, problem-solving, and monitoring of key performance metrics.
The position also involves developing and mentoring team members, promoting a positive and safe work culture, and ensuring consistent alignment with Made Scientific’s mission to deliver life-changing therapies.
Key Responsibilities
Provide strategic direction to the Sterile Production Team, ensuring alignment with the organization’s core values and commitment to high-quality outcomes.
Oversee sterile production operations, ensuring compliance with cGMP, regulatory requirements, and production schedules while maintaining accurate documentation, SOPs, and equipment standards.
Supervise daily operations, spending approximately 50% of time in cleanroom environments, reviewing batch records, and addressing production issues to ensure product quality and safety.
Support continuous improvement through root cause analysis, feedback, and monitoring of KPIs to improve metrics such as scrap, non-conformance, and plant efficiency.
Lead hiring, training, and performance management initiatives to build a skilled, engaged, and safety-focused team.
Foster a collaborative and compliant work culture with strong adherence to environmental, health, and safety standards.
Partner cross-functionally with Quality, Engineering, and Process Development teams to support operational alignment and improvement projects.
Perform other duties as assigned.
Required Qualifications
Bachelor’s degree in Science, Engineering, or a related field, or equivalent experience.
Minimum 4 years of operations experience within a cGMP environment in the biotech or biopharma industry.
Minimum 1 year of leadership, supervisory, or management experience (preferred).
Prior experience in manufacturing, quality, or engineering is required.
Excellent communication, leadership, and organizational skills.
Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).
Strict adherence to SOPs, GMP regulations, FDA guidance, and documentation best practices.
Preferred Qualifications
Experience with cell therapy automation technologies, closed‑system culture vessels, cell washers, and cell separation technologies for autologous/allogeneic product manipulation.
Hands‑on experience in handling, propagation, isolation, activation, and cryopreservation of human primary cells, including T cells.
Physical Requirements
Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and other applicable standards, including meeting productivity expectations.
Regular, punctual attendance is required.
Must be willing to be gown‑qualified and work in CNC/ISO8/ISO7 cleanroom environments.
Must be able to lift up to 25 lbs.
Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.
Must be able to sit or stand for extended periods.
Must be willing to work with cell‑based products, chemicals, and hazardous materials.
Work Schedule
Must be available to work weekends, holidays, and extended hours as required to meet production needs. Flexibility to accommodate changing production schedules is expected.
#J-18808-Ljbffr