* Provide integrated Safety, Occupational Health and Environmental Affairs (SHE) services to support and enable ongoing business operations at the Frederick site which includes offices, laboratories, Large Scale Manufacturing and parking.
* Support/ align with the Frederick Site SHE vision and policy; oversee implementation of the SHE Management System; set Site SHE objectives and targets; establish roles and responsibilities for supporting programs; review, evaluate, and report on Site SHE performance; and periodically audit and review the SHE Management System effectiveness.
* Protect the health and safety of key stakeholders including employees, contractors, visitors and others affected by Frederick Site Operations.
* Assist in/ assemble the appropriate set of multidisciplinary professionals through a combination of internal staff and external contractors which integrate people, process and technology to ensure a safe and healthy workplace and minimize environmental impact in a sustainable manner.
* Support, recommend and implement SHE Strategic Plans and Programs which identify and communicate workplace hazards, remove hazards, and establish engineering and administrative controls (including training) uniquely matched to the hazards.
* Maintain awareness of advancing technology, innovations in safe workplace practices, environmental design and operational practices which impact employee safety and health, the environment, and external perceptions of the company.
* Maintain awareness of changes to applicable regulations and ensure site changes are made to meet regulations including EPA, FDA, DOT, OSHA, AAALAC, CDC, MDE, DEA, NRC, DOL-WC and other governing bodies.
* Assist/ direct the responsible investment of SHE Site Expense Budget to provide and maintain appropriate services and which enable site functions to continue ongoing operations.
* Integrate SHE Services with other Frederick Site Operations strategic efforts, as well as, AstraZeneca. Work closely with Site Leadership Team to implement key initiatives.
* Assist/ support the long term plans for Frederick through participation in Site Master Plan development process and Capital Planning activities.
* Assist/ provide SHE consulting support on capital projects during planning, risk & hazard evaluation, design and construction phases of the project.
* Integrate Business Continuity Planning and Loss Prevention into Site Operations business processes, planning, and decision making.
* Oversee selection, development and implementation of Laboratory Safety Programs designed to address site-specific requirements.
* Identify risks and hazards associated with site activities and implement programs and procedures to eliminate, control or minimize hazards. Key programs include: Core OSHA Safety, Laboratory Safety (Biological, Chemical & Radiation), Hazardous Chemicals & Waste Management, Process Safety, Contractor Safety and Lab Animal Safety.
* Assist/ support SHE staff members to fulfill regulated roles and represent site as Subject Matter Expert (SME) on technical matters. The roles include: Institutional Biosafety Officer, Chemical Hygiene officer, T&R Officer (NRC), Responsible Officer (CDC) and Radiation Safety Officer.
* Establish and maintain Hazardous Chemicals and Waste Program to administer: HAZCOM, Chemical Hygiene Plan, Chemotherapy Drug Management and Hazardous Material & Waste Management Plan.
* Establish and maintain the Radiation Safety Program to manage: Use Protocol Review & Approval; Increased Control Permit Compliance; and Monitoring & Survey Contract Management.
* Establish and maintain Laboratory Safety Program to manage: semi-annual inspections; Controlled Substance Use Program; and Sharps Prevention Program.
* Provide SME consulting support to Shipping and Receiving on characterization of potential hazardous materials from laboratories and manufacturing.
* Evaluate, revise and establish KPIs (Key Performance Indicators) and other metrics which assess site performance and are consistent with AstraZeneca and industry best-in-class performance.
* Assist/ support site participation in SHE industry benchmarking surveys and present results to senior leadership team.
Site Safety Operations:
* Oversee selection, development and implementation of Site Safety Programs designed to address site-specific requirements.
* Establish Core OSHA Safety Compliance Programs to address: fire and life safety, fire alarm impairment, emergency response, Lockout Tagout (LOTO), hot work, powered industrial vehicles, and confined space access.
* Establish Contractor Safety Program to oversee compliance with work performed on-site by external service providers involved in construction projects, Site Operations, Lab Operations, and Manufacturing.
Manufacturing & Process Safety:
* Oversee selection, development and implementation of Manufacturing and Process Safety Programs designed to address site-specific requirements in GMP and Manufacturing.
* Ensure work processes and systems are in-place to effectively conduct design hazard reviews, process hazard analysis, mechanical integrity design and testing for highly hazardous chemicals storage and handling, human factors (ergonomics) assessments, and selecting inherently safer designs.
* Develop site-specific Behavioral Safety Program (BeSHE) in alignment with AZ's program aimed at improving safety performance in the global Operations function.
* Assist/ support selection, development and implementation of Occupational Health Programs which define the site-specific needs in the areas of Medical Surveillance and Employee Health.
* Establish appropriate employee and contractor medical surveillance for: respiratory protection, vaccinations, hearing conservation, and allergies.
* Establish employee health services for: injury and illness response and management; workplace claims filing and management; return to work programs; OSHA recordkeeping; PPE management and ergonomics.
* Assist/ support the selection, development and implementation of Environmental Affairs and Compliance Programs which define the site-specific approach for compliance with corporate and regulatory requirements.
* Ensure processes and systems are in-place for: preparation and submittal of Regulatory Reports; Permit Applications and Renewal; and Spill Prevention Control and Countermeasures (SPCC) Regulation and Management.
* Ensure site readiness for audits and inspections.
* Assist/ support negotiations with regulatory agencies such as FDA, EPA, and DOT on specific regulatory requirements, permit conditions and responses to noncompliance.
* Establish resource conservation and sustainability initiatives including waste minimization, recycling and reuse in key site-specific areas.
Expense Budget Management:
* Assist/ manage Frederick's SHE Site Expense Budget. Estimate, track, forecast and report budgets and sub-budgets; analyze trends and make budget recommendations.
* Assemble, build, and create cashflow forecast for SHE Site expense budget including headcount forecast.
* Maintain compliance with Sarbanes-Oxley regulations.
* Participate in developing LROP (Long Range Operating Plan) for Site Operations capital and expense budgets.
Contract SHE Services:
* Oversee development of supplemental contract agreements with external service providers for specialty SHE services and additional labor in response to work volume changes and deadlines.
* Develop and maintain long-term business relationships with key service providers.
* Develop contact management process for all services. Include implementing Contract Governance Program to maintain required performance levels and overall health of the business and operational relationships.
* Build KPIs (Key Performance Indicators) into contract performance evaluation systems to ensure focus on measurable outcomes.
* Monitor, audit and ensure service providers operate in accordance with approved management controls.
* Develop a contract service provider risk management and mitigation plan, policy and process to remove, shift or limit risk to the company.
* Continuously manage customer expectations and monitor customer satisfaction levels of all applicable key stakeholder groups for each service area.
* Implement change management control system for each service to ensure all requested service changes are documented and approved. Monitor changing business conditions and define required service changes.
* Determine contract exit strategy for each contractual relationship to ensure seamless delivery of the affected service area. Implement strategy where service provider changes are required.
* Periodically obtain competitive pricing for each service contract. Write, review, edit and respond to Requests for Information (RFI) and Requests for Proposals (RFP) as required for procurement of contract services.
Additional Job Functions:
* Assist/ support overall strategic vision and direction for SHE Site Operations.
* Provide guidance and coach SHE Site Leadership Team to develop high-performing work teams within their functional areas.
* Provide/ assist as interface to BOLT on SHE Site service areas of discussion.
* Utilize knowledge and communication skills to change the thinking of or gain acceptance of others in sensitive situations.
Directs through lower management levels. Has responsibility for managing a function that includes multiple related departments.
15+ years experience in Safety, Health and Environmental operations
Certificates, Licenses, Registrations:
CIH certification preferred.
Bachelors degree in Biology, Chemistry, Environmental Science, Industrial Hygiene, Occupational Health, Engineering or similar field; Masters degree in related field preferred.
MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune's approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune's approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.
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Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities... that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.