Minaris Advanced Therapies
Be part of something bigger at Minaris Advanced Therapies-where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market.
At Minaris, you'll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you're in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine-one patient at a time.
Position Summary
The QC Analytical Supervisor
(2nd Shift, 2:30-11:00PM)
will organize and direct staff to meet and exceed cGMP requirements, and establish KPI's, while adhering to quality control and technical standards. This role will also provide oversight of day-to-day activities including adjustment of workflow, test performance, and quality compliance.
Essential Functions and Responsibilities
Below is the summary of the role responsibilities. This is not an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.
Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
Schedules and monitors daily operation of the department based on projected client demands.
Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.
Approval of investigations and documentation of non-confirming events and OOS.
Recommends process improvements to achieve greater efficiency within the department and between sites.
Participate in department and cross functional meetings.
Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.
Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs.
Builds and manages a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensure staff are recruited and selected using merit principles. Ensure tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues.
Promotes efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identifies and implements improvements and innovations that increase efficiency and enhance work quality. Promotes ongoing development of staff and takes the initiative to assess and develop supervisory competencies.
Other duties as assigned.
Leadership Responsibility
Determines staffing needs and leads recruitment, interviewing, hiring, and onboarding of QC Analytical team members.
Provides day-to-day oversight in alignment with organizational policies, GMP regulations, and QC procedures.
Coaches, mentors, and develops staff; supports onboarding and drives career development planning and training opportunities.
Empowers team members by delegating responsibilities, setting clear expectations, and providing consistent feedback and accountability.
Fosters a culture of teamwork, collaboration, and problem-solving, addresses conflicts promptly and constructively.
Promotes a workplace culture aligned with the organization's mission, vision, and core values.
Leads performance management activities, including goal setting, performance reviews, and individual development planning.
Effectively communicates key information via team meetings, one-on-one discussions, and written communication.
Reviews QC data packages and records to ensure accuracy and compliance; prepares Certificates of Analysis for product release.
Represents the QC function in cross-functional meetings and external/internal audits as needed.
Leads and facilitates Tier 1a huddles and contributes to other Tier meetings to ensure team alignment and issue resolution.
Knowledge, Skills & Ability
Strong knowledge of FDA and EU regulatory standards. cGMP experience required.
Strong knowledge of analytical test methods and philosophies.
Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
Proficient with computer software with MS Office, iStability and LIMS.
Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze, and resolve problems effectively.
Build and maintain relationships
Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders.
Communicate effectively.
Uses appropriate modes and media, targeting the amount, level of detail, and content of the information to the needs of the audience. Prepare clear, concise, and well-organized written documents and oral presentations. Convey information clearly, confidently, and with the proper tone. Facilitates open communication. Uses discretion and demonstrates sensitivity to confidentiality concerns. Listens effectively and provides appropriate feedback.
Fosters continuous improvement and innovation.
Displays and fosters integrity and honesty through the promotion of mutual trust and respect, demonstrates and fosters high ethical standards, and treats others fairly and ethically.
Supervises and manages performance.
Manages projects and functions.
Education & Experience
Bachelor's degree in science or relevant field Minimum of 7+ years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent. Strong knowledge of FDA and EU regulatory standards. cGMP experience required. Strong knowledge of analytical test methods and philosophies. Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review. Proficient with computer software with MS Office, iStability and LIMS.
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
Shift:
2nd Shift, 2:30-11:00PM
The estimated base salary range for each open position based in the United States of America is included for all our current openings. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual's qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) as part of the compensation package. Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.
At Minaris, you'll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you're in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine-one patient at a time.
Position Summary
The QC Analytical Supervisor
(2nd Shift, 2:30-11:00PM)
will organize and direct staff to meet and exceed cGMP requirements, and establish KPI's, while adhering to quality control and technical standards. This role will also provide oversight of day-to-day activities including adjustment of workflow, test performance, and quality compliance.
Essential Functions and Responsibilities
Below is the summary of the role responsibilities. This is not an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.
Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
Schedules and monitors daily operation of the department based on projected client demands.
Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.
Approval of investigations and documentation of non-confirming events and OOS.
Recommends process improvements to achieve greater efficiency within the department and between sites.
Participate in department and cross functional meetings.
Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.
Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs.
Builds and manages a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensure staff are recruited and selected using merit principles. Ensure tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues.
Promotes efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identifies and implements improvements and innovations that increase efficiency and enhance work quality. Promotes ongoing development of staff and takes the initiative to assess and develop supervisory competencies.
Other duties as assigned.
Leadership Responsibility
Determines staffing needs and leads recruitment, interviewing, hiring, and onboarding of QC Analytical team members.
Provides day-to-day oversight in alignment with organizational policies, GMP regulations, and QC procedures.
Coaches, mentors, and develops staff; supports onboarding and drives career development planning and training opportunities.
Empowers team members by delegating responsibilities, setting clear expectations, and providing consistent feedback and accountability.
Fosters a culture of teamwork, collaboration, and problem-solving, addresses conflicts promptly and constructively.
Promotes a workplace culture aligned with the organization's mission, vision, and core values.
Leads performance management activities, including goal setting, performance reviews, and individual development planning.
Effectively communicates key information via team meetings, one-on-one discussions, and written communication.
Reviews QC data packages and records to ensure accuracy and compliance; prepares Certificates of Analysis for product release.
Represents the QC function in cross-functional meetings and external/internal audits as needed.
Leads and facilitates Tier 1a huddles and contributes to other Tier meetings to ensure team alignment and issue resolution.
Knowledge, Skills & Ability
Strong knowledge of FDA and EU regulatory standards. cGMP experience required.
Strong knowledge of analytical test methods and philosophies.
Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
Proficient with computer software with MS Office, iStability and LIMS.
Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze, and resolve problems effectively.
Build and maintain relationships
Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders.
Communicate effectively.
Uses appropriate modes and media, targeting the amount, level of detail, and content of the information to the needs of the audience. Prepare clear, concise, and well-organized written documents and oral presentations. Convey information clearly, confidently, and with the proper tone. Facilitates open communication. Uses discretion and demonstrates sensitivity to confidentiality concerns. Listens effectively and provides appropriate feedback.
Fosters continuous improvement and innovation.
Displays and fosters integrity and honesty through the promotion of mutual trust and respect, demonstrates and fosters high ethical standards, and treats others fairly and ethically.
Supervises and manages performance.
Manages projects and functions.
Education & Experience
Bachelor's degree in science or relevant field Minimum of 7+ years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent. Strong knowledge of FDA and EU regulatory standards. cGMP experience required. Strong knowledge of analytical test methods and philosophies. Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review. Proficient with computer software with MS Office, iStability and LIMS.
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
Shift:
2nd Shift, 2:30-11:00PM
The estimated base salary range for each open position based in the United States of America is included for all our current openings. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual's qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) as part of the compensation package. Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.