At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. As a member of our team, you'll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us, every moment of every day, to develop rapid groundbreaking solutions for the world's most complex health challenges.
Global Biosafety Officer (BSO) is a key position with responsibility in overseeing the safe use of biohazardous material in accordance with all applicable regulations. Cepheid has experienced a rapid growth and diversification in the number and type of product offerings and as such the new projects require the use of a broader range of microorganisms, as well as additional types of specimens.
The BSO ensures adequate biosafety training and practices to avoid potential hazards associated with the handling of biohazardous materials, the spread of pathogens, threats of emerging pathogens, and control of amplifiable nucleic acids. The BSO develops training materials and monitors adherence to laboratory biosafety programs and assists other safety professionals and scientists with risk assessments and risk mitigation plans. The BSO works with key partners to improve communications, emergency management and response practices.Knowledge of clinical and/or public health microbiology and general laboratory practices are required. Effective communication skills and practical experience in laboratory safety, training, and quality management systems are necessary for this position.
ESSENTIAL JOB RESPONSIBILITIES:
- Knowledge of clinical and/or public health microbiology and general laboratory practices are required.
- Is a permanent member of the Biohazard Use Review Committee (BURC), which is Cepheid's biosafety steering committee (the BURC establishes policies to guide investigators in support of the safety of lab personnel)
- Chairing a BURC meeting in the absence of the BURC Chair;
- Physical inspection of the lab of any BUA applicant as part of the application approval process;
- Overseeing biosafety training to the laboratory, as needed, prior to the approval of an application;
- Informing the Chair of the BURC of any unsafe lab condition or laboratory accident/incident;
- Review of BUA applications to ensure they comply with BURC policy;
- Approval of BUA applications after considering input from BURC committee members and invited reviewers; and review and approval of BUA Application Form Amendments.
- Leads the evaluation of projects and activities submitted to the BURC to assess the risks and mitigations necessary for the safe handling of biohazardous materials needed for projects and on-going activities throughout Cepheid.
- Oversees Cepheid's policies and practices used for the control of amplifiable nucleic acid contamination as a member of the BURC.
- Collaborates with Medical and Scientific Affairs personnel, occupational health experts and other partners to maintain an effective biosafety program.
- Ensures associate compliance with Cepheid's Hepatitis B Vaccine policy.
- Conducts or oversees periodic inspections of laboratories. Works with area managers or Facilities to address findings and opportunities for improvement.
- Conducts accident/incident investigations including post-exposure evaluations and follow-up, as necessary.
- Designs work practices and procedures to minimize exposure to hazards and to adhere to regulatory requirements.
- Works with laboratory managers and staff to investigate incidents and complaints; recommends corrective action as needed.
- Provides guidance on decontamination and works with other safety professionals to maintain a laboratory waste management plan that adheres to federal, state, and local regulations.
- Develop training materials and monitor adherence to laboratory biosafety programs and assists with risk assessments and risk mitigation plans.
- Manage and implement all occupational health and management systems associated with biosafety and in accordance with governmental and company requirements.
- Promote and support the biosafety needs of the Cepheid organization.
- Guide the development of policies and procedures to ensure the safety of laboratory staff, and the provision of a safe physical environment to meet biosafety and broader safety requirements.
- Create and adjust methodologies and policies to meet Cepheid's rapidly changing scientific and regulatory environment.
- Interpret and apply relevant laws, regulations, codes, and standards, to make recommendations for work environment changes based on interpretations and principles of professional practices.
- Oversee biosafety training globally, deliver training to a diverse group of associates representing 55 different departments, many with little or no background in life sciences.
- Create, present, and manage training in an electronic and in-person format.
- Work with other groups to ensure that associates granted access to Cepheid laboratories are adequately trained and compliant with existing regulations and policies.
- Assist team leaders in assessing project-specific training and laboratory competency needs.
- Educate, train and provide guidance for performing biosafety risk assessments, manage risks through systematic practices to evaluate, minimize, or eliminate them.
- Review and update the Biosafety and Bloodborne Pathogen Exposure Control Plan annually to reflect changes and additions to the Federal and State regulations.
- Partner with Cepheid site leaders to continuously improve the safety culture, awareness, and accountability in support of EHS programs.
- Evaluate proposed Federal, state, and local EHS compliance laws and regulations to determine impact to compliance programs and business operations
- Work with key partners to improve communications, emergency management and response practices in the area of biosafety management.
- Manage global biosafety compliance metrics.
- Support the Cepheid EHS audit function in the areas of biosafety program management.
- Must demonstrate personal integrity and high ethical standards
- Complete all assigned and required training satisfactorily and on time
Education and Experience (in years):
- Bachelor's degree with 12+ years of related work experience OR
- Master's degree in field with 8+ years of related work experience OR
- Doctoral degree in field with 5+ years of related work experience.
Knowledge and skills:
- Excellent written, verbal, and interpersonal communication skills are essential, must be able to communicate technical concepts clearly to a diverse audience.
- Experience in managing a biological safety program including drafting, presenting, and enforcing biological safety practices.
- Understanding and experience with safe methods for manipulating, studying, propagating, and containing infectious microorganisms.
- Knowledge of BSL-2 and BSL-3 operations and practices
- Knowledge and skill in the application of physical containment requirements for safely working with biohazardous materials.
- Knowledge and skill in applying and interpreting applicable local, state, and federal regulations, standards and guidelines.
- Knowledge of clinical and infectious disease laboratory practice.
- Ability to establish working relationships with groups that have diverse backgrounds and significantly different needs.
- Skilled in the management of on-line systems for delivering and tracking associate training.
- Willingness and openness to professional development.
- Successfully managed a biosafety program in an industrial, academic, or clinical laboratory setting.
- Understands policies and procedures for the control of amplifiable nucleic acid contamination in a research, development and manufacturing setting.
- Must have direct BSO experience
- Ability to solve complex problems by actively seeking information and new ideas from a variety of sources, consistently looking for novel ways to solve problems, and mastering unfamiliar information, tasks, and situations quickly and effectively
- Must be highly proficient in Excel and data analysis
- Strong computer-based skills, specifically with Microsoft Word and Power Point programs.
- Must be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm/wrist motions.
- Will travel both domestically and internationally up to 20%
- Must have or be able to get a current passport
- 15 years of experience in the field of Microbiology, Biology, Clinical Laboratory Science, Medical Technology, or related health sciences field and a Bachelor's degree in Microbiology, Biology, Clinical Laboratory Science, Medical Technology or related health sciences field.
- Certified Biosafety Professional (CBSP) or Registered Biosafety Professional (RBP).
- Strong people skills as the position will be required to influence people
- Safety Culture through Grassroots Safety
- Black or Green Belt Six Sigma
- Lean Tools
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
As part of the Danaher family of companies, our work at Cepheid is supported by a global science and technology innovator. In addition to Danaher's unrivaled leadership training and professional development programs, this relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life's Potential.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here.