Laboratory Operations Manager

Laboratory Operations Manager

Seize a unique opportunity to lead the lab operations of a cutting-edge biotech company and make a difference in the healthcare industry! In this critical role, you will be the driving force behind seamless day-to-day lab operations and play a key role in advancing cutting-edge biotech solutions. If you're a leader with a passion for science and a track record of success, this is your opportunity to thrive in a fast-paced, dynamic environment.

Summary

The Laboratory Operations Manager is responsible for the day-to-day management of laboratory sections (BSM, PAX, IHC/ISH/IF, DNA/RNA). He/she ensures that the staff is properly trained and competent with all the techniques used and monitors the performance of the staff. He/she also monitors the quality of the laboratory's work and documentation to ensure compliance with applicable requirements. He/she takes responsibility for all aspects of the lab, including equipment, employees, supplies, software, and documentation.

Responsibilities

 Quality & regulatory responsibilities

• Adherence to company policy on patient and client confidentiality.
• Develop and implement policies, procedures and standards for lab operations to ensure the efficiency, effectiveness, and quality control of the laboratory and compliance with the CellCarta’s quality standards.
• Responsible for maintaining compliance with relevant portions of CLIA regulations and CAP guidelines.
• Work with quality assurance personnel to maintain the quality of laboratory services provided
• Develop procedures and processes to support ISO 13485 and FDA approval of the Naperville site

  People management & planning

• Daily Management of laboratory personnel (BSM, PAX, IHC/ISH/IF, DNA/RNA).
• Supervise staff training in the performance of laboratory functions - both administrative and technical operating procedures.
• Monitor staff proficiency, productivity and performance.
• Plan and schedule work for the group to ensure proper distribution of assignments as well as adequate manning, space and facilities.
• Ensure the health and safety of the staff in the lab environment.

   Lab/Technical responsibilities

• Identify and troubleshoot problems that may adversely affect timeliness, quality of results and resources. Coordinate with the project manager or client on issues which impact laboratory services.
• Solve specific operating problems and improve technical activities. Advise on technical procedures, techniques and equipment, and maintain conformance with specific global operational standards.
• Coordinate installation and maintenance of laboratory equipment in compliance with the CellCarta’s quality standards.
• Manage lab inventory & stock in an efficient, cost-effective manner and compliant manner. Work with ordering personnel to ensure orders are placed in a timely manner. Order reagents and supplies as needed.

   Admin tasks & communication

• Work in matrix structure with respective department heads to ensure global alignment of equipment, processes and people.
• Perform other related duties as requested by the supervisor.

Qualification and Skills

• Bachelor’s degree or higher in chemical, physical, biological or clinical laboratory science.
• At least 5 years proven work experience as a team leader; experience in matrix organizations is a plus.
• Strong knowledge of histopathology and good knowledge of genomics techniques is required.
• Strong knowledge of working in a quality environment (CAP; CLIA; ISO 13485) is required.
• Experience in a CRO is seen as a plus.
• Experience with NGS or FISH is a plus.
• Excellent written and oral communication (English) skills.
• Organized with excellent time-management skills.
• Collaboration and partnership with other functional areas to drive organizational success.
• Flexible to guide team within and outside business hours.
• Able to prioritize his/her work as well as the work of others.

Benefits

CellCarta is made up of dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world! 

We offer a wide range of benefits including: 

• Competitive wages: $100,000 - 135,000
• Medical, dental, and vision benefits 
• 401k retirement savings plan with a healthy match 
• Vacation and sick time 
• Career development opportunities 
• Continuing education 

About Us  

CellCarta is a rapidly growing, stable company. We are a leading provider of pre-clinical and clinical trial services to pharmaceutical and biotechnology companies. Our laboratory service offerings include immunohistochemistry, FISH, CTC isolation and characterization, chemosensitivity testing, tissue procurement, flow cytometry, ELISA, mutation testing, cell expansion, and colony-forming assays. CellCarta is a CLIA-licensed and CAP-accredited laboratory, and we perform studies in compliance with the relevant portions of Good Laboratory and Good Clinical Practices. 

Join us as we make an impact on the future of patient therapy!