Curium Pharma
Manager Microbiology
Curium Pharma, Noblesville, Indiana, United States, 46060
Manager Microbiology
Date:
Oct 2, 2024
Location:
Noblesville, IN, United States
About CuriumCurium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.Summary of PositionThe Manager Quality Control Microbiology is responsible for ensuring accountability, transparency, and effective communication cross-functionally and within his/her team while ensuring information is timely, clear and accurate. Coaching and developing will foster team ownership that ensures compliance with all policies, procedures and regulations. Must ensure maintain operational compliance with U.S. and international regulatory agencies (i.e. FDA, EU, ISO, USP, NRC, etc.) In addition, must supply the highest level of both internal and external customer service and measure and communicate the team's progress against individual, team and site goals and Key Performance Indicators (KPI's).The Manager Quality Control Microbiology manages the activities of a dosage pharmaceutical quality control unit in the performance and analysis under GMP conditions for the entire site. Scope of responsibility includes raw material, in-process and finished goods testing and release as well as stability requirements for finished packaged goods. It also includes Environmental Monitoring of controlled environments to assure controlled environments are maintained.Essential FunctionsManage Quality Control laboratories: Microbiology/Environmental Monitoring.Ensure all necessary testing is carried out.Approve specifications, sampling instructions, test methods, procedures and other QC procedures.Approve and monitor any contract testing laboratory for compliance and test results.Ensure appropriate validations/qualifications are completed and approved.Ensure laboratory records are evaluated and signed by an authorized person before they are sent to the QA department.Ensure accountability, transparency, and effective communication cross-functionally and within the team while guaranteeing information is timely, clear and accurate.Coach and develop the team to team ownership.Ensure team compliance with all policies, procedures and site/company regulations.Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member's performance management.Exhibit accountability and responsibility for an area or process in order to affect change and lead efforts and ideas to completion.Provide leadership for employee relations through effective communications, coaching, training and development and eliminate roadblocks in order for the team to move forward.Supply the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems.Understand and provide education and feedback to team regarding business and financial impact of decisions/actions.Ensure all direct reports maintain ALARA and manage their daily activities accordingly to ensure they meet their quarterly ALARA goals.Ensure strong adherence to safety procedures.Ensure team meetings are held to update team and track progress.Lead team in continuous improvement activities.Ensure proper maintenance and cleanliness of the department, premises and equipment.Measure and communicate team's progress against individual, team and site goals and Key Performance Indicators (KPI's).Maintain an acceptable level of 5S in the area. Assure the laboratories are maintained to promote an organized workspace.Recognize and reward performance.Lead and/or support all investigations. Review and approve area quality and safety exceptions and investigation reports. Ensure on-time completion of investigations and corrective action items assigned to area.Verify, review and make appropriate changes if needed, to any controlled document pertinent to area of responsibility.Identify opportunities to reduce risk, reduce cost of poor quality and improve service.
Requirements
Bachelor Degree in scientific discipline required or equivalent work experience.12or more years Quality Control relevant leadership experience, with two or more years of experience in a management role; (preferably managing a team of ten or more multi-shift employees).Strong knowledge of cGMP requirements.Strong knowledge of laboratory equipment/product validationComplete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories through hands-on experience working in a Pharmaceutical manufacturing facility laboratory.Expertise in the manufacture and control of finished products, analytical analysis techniques and statistical quality control.Working knowledge of regulatory (FDA, EU, ISO, USP, etc) requirements and applicable testing Guidelines. Background must include analytical method validation work.Thorough understanding of Quality systems.Ability to use relevant software packages to process and analyze data.
Working ConditionsWillingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.May be required to sit or stand for long periods of 8+ hours a day while performing duties.Must possess good hand-eye coordination; close attention to detail is required.Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.Willingness to complete safety training within allotted timeframes, and work in a team-based environment.Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
CompetenciesDisclaimerThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.Equal Opportunity EmployerCurium is anequal opportunity employerand believes everyone deserves respect, dignity and equality.All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Job Segment:QC, Testing, Compliance, Microbiology, Medical Technologist, Quality, Technology, Legal, Science, Healthcare
Date:
Oct 2, 2024
Location:
Noblesville, IN, United States
About CuriumCurium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.Summary of PositionThe Manager Quality Control Microbiology is responsible for ensuring accountability, transparency, and effective communication cross-functionally and within his/her team while ensuring information is timely, clear and accurate. Coaching and developing will foster team ownership that ensures compliance with all policies, procedures and regulations. Must ensure maintain operational compliance with U.S. and international regulatory agencies (i.e. FDA, EU, ISO, USP, NRC, etc.) In addition, must supply the highest level of both internal and external customer service and measure and communicate the team's progress against individual, team and site goals and Key Performance Indicators (KPI's).The Manager Quality Control Microbiology manages the activities of a dosage pharmaceutical quality control unit in the performance and analysis under GMP conditions for the entire site. Scope of responsibility includes raw material, in-process and finished goods testing and release as well as stability requirements for finished packaged goods. It also includes Environmental Monitoring of controlled environments to assure controlled environments are maintained.Essential FunctionsManage Quality Control laboratories: Microbiology/Environmental Monitoring.Ensure all necessary testing is carried out.Approve specifications, sampling instructions, test methods, procedures and other QC procedures.Approve and monitor any contract testing laboratory for compliance and test results.Ensure appropriate validations/qualifications are completed and approved.Ensure laboratory records are evaluated and signed by an authorized person before they are sent to the QA department.Ensure accountability, transparency, and effective communication cross-functionally and within the team while guaranteeing information is timely, clear and accurate.Coach and develop the team to team ownership.Ensure team compliance with all policies, procedures and site/company regulations.Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member's performance management.Exhibit accountability and responsibility for an area or process in order to affect change and lead efforts and ideas to completion.Provide leadership for employee relations through effective communications, coaching, training and development and eliminate roadblocks in order for the team to move forward.Supply the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems.Understand and provide education and feedback to team regarding business and financial impact of decisions/actions.Ensure all direct reports maintain ALARA and manage their daily activities accordingly to ensure they meet their quarterly ALARA goals.Ensure strong adherence to safety procedures.Ensure team meetings are held to update team and track progress.Lead team in continuous improvement activities.Ensure proper maintenance and cleanliness of the department, premises and equipment.Measure and communicate team's progress against individual, team and site goals and Key Performance Indicators (KPI's).Maintain an acceptable level of 5S in the area. Assure the laboratories are maintained to promote an organized workspace.Recognize and reward performance.Lead and/or support all investigations. Review and approve area quality and safety exceptions and investigation reports. Ensure on-time completion of investigations and corrective action items assigned to area.Verify, review and make appropriate changes if needed, to any controlled document pertinent to area of responsibility.Identify opportunities to reduce risk, reduce cost of poor quality and improve service.
Requirements
Bachelor Degree in scientific discipline required or equivalent work experience.12or more years Quality Control relevant leadership experience, with two or more years of experience in a management role; (preferably managing a team of ten or more multi-shift employees).Strong knowledge of cGMP requirements.Strong knowledge of laboratory equipment/product validationComplete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories through hands-on experience working in a Pharmaceutical manufacturing facility laboratory.Expertise in the manufacture and control of finished products, analytical analysis techniques and statistical quality control.Working knowledge of regulatory (FDA, EU, ISO, USP, etc) requirements and applicable testing Guidelines. Background must include analytical method validation work.Thorough understanding of Quality systems.Ability to use relevant software packages to process and analyze data.
Working ConditionsWillingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.May be required to sit or stand for long periods of 8+ hours a day while performing duties.Must possess good hand-eye coordination; close attention to detail is required.Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.Willingness to complete safety training within allotted timeframes, and work in a team-based environment.Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
CompetenciesDisclaimerThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.Equal Opportunity EmployerCurium is anequal opportunity employerand believes everyone deserves respect, dignity and equality.All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Job Segment:QC, Testing, Compliance, Microbiology, Medical Technologist, Quality, Technology, Legal, Science, Healthcare