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Manager Biological Safety


St. Louis, MO
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Job Details

This role is primarily responsible for providing technical biosafety support and implementing & overseeing biological safety programs as the Bio-Safety Officer (BSO) for all Chesterfield facility operations to ensure a safe workplace and compliance with regulatory and Pfizer EHS requirements. The BSO will also be responsible for implementing important aspects of the EHS management system such as operational control, risk assessment, inspections, program and compliance improvements, and investigations. This position requires a 'hands-on approach' to partner with multiple business lines and colleagues to ensure compliance with applicable guidelines, regulatory and Pfizer EHS standards, and continuous improvement of EHS performance. This position is accountable for compliance to regulatory and Pfizer requirements as part of an integrated EHS compliance program and will be accountable to the site Global Operations Risk Management (RMS) Lead, Global Operations Site Lead and the site Business Unit/Research Unit leadership team.

+ Implements and oversees biological safety programs as the Bio-Safety Officer for the site covering infectious or potentially infectious materials, including bloodborne pathogens, work with human and non-human primate materials, and recombinant and synthetic nucleic acids

+ Provides advice and support to the scientific lines on the implementation of Pfizer Health & Safety standards, site safety policies, standards and procedures, and regulations governing biological safety

+ Maintains and develops safety management systems (including policies & procedures and training) that enhance the biological safety programs

+ Review and approve studies involving biological agents through Pfizer's electronic Biological Agent Registration (eBAR) system

+ Develops metrics to measure performance and goals to achieve continuous improvement in safety performance

+ Actively support and lead the site BioSafety Committee

+ Review and approve the purchase of biological agents

+ Perform and document risk assessments of chemical and biological agent use, and associated equipment in consultation with customers and other EHS colleagues

+ Perform and support lab safety inspections, investigations, and continuous improvement programs

+ Liaises with internal customers/stakeholders

+ Develops and communicates specific biosafety handling practices to meet hazard mitigation and risk reduction.

+ Investigates workplace incidents, determines root cause, and develops corrective actions.

+ Participate in global networks including the Biosafety Safety Network and Lab Safety Network

+ Other related assignments as identified by RMS/EHS and GO management as deemed appropriate

**Education and Experience** :

+ Bachelor's degree in the biological or physical sciences

+ Minimum of seven years' experience implementing biosafety-related programs or related experience working with biological materials in a laboratory setting in combination with safety committee participation

+ Subject material expertise in NIH and BMBL guideline application

+ Preferred:

+ Master's degree

+ Registered Biosafety Professional and an active member of the American Biological Safety Association.

+ Prior experience in the biopharmaceutical industry

+ Prior experience in gene therapy or viral vector research

+ Prior experience on an institutional biosafety committee

**Technical/Job-Related Skills** :

+ Possesses a strong understanding of biosafety principles, laboratory and large scale biosafety programs, and key processes such as risk assessment, inspections, audits and root cause investigations.

+ Ability to independently assess biosafety risks and programs and sensitively communicate/collaborate with line management on appropriate risk control measures

+ Demonstrated working knowledge of local, state and federal regulatory requirements and guidelines associated with biosafety

+ Ability to identify, drive change, and implement improvement programs across a multi-discipline organization without having direct management or control over colleague performance

+ Exceptional interpersonal and negotiation skills

+ Strong verbal and written communication skills

+ Self-motivated/self-starter with ability to multi-task and work effectively with minimal supervision

+ Proficiency with the Microsoft Office Suite of computer programs

**Organizational Relationships**

+ Reports to site RMS Lead

+ Interacts with Occupational Health & Wellness personnel and other members of the site Global Operations (Compliance, Maintenance, Operations, Business Planning and Facility Solutions) team

+ Occasionally interacts with site senior leadership

+ Interacts regularly with scientific lines and vendors supporting those lines

+ Interacts with Pfizer Global EHS and the Biosafety Network

+ Interacts with Pfizer Legal Groups including Global EHS Legal

+ Liaises with regulatory compliance organizations

+ Interacts with Biological Safety Officers from other sites


Due to the nature of work assignment, the Senior Advisor - Biosafety must be able to perform detailed work on multiple, concurrent tasks, with frequent interruptions and under time constraints. On a daily basis, the position responsibilities may require the ability to stoop; to reach; to stand, to walk the site for extended periods of time; to push and/or pull objects weighing up to 30 pounds; to lift and carry objects weighing up to 15 pounds; to sit/stand at a computer workstation for extended periods of time. On a frequent basis, essential duties of the position may require the ability to climb stairs, to kneel and/or crouch to retrieve items.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative

**Additional Offer Details:**

- Last Date to Apply for Job: 11/24/2017

- Grade: 10

- Additional Location Information: MO-Chesterfield

- Eligible for Employee Referral Bonus: Yes

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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