Job Description - Position Summary:
The Associate Director, Manufacturing and Process Safety has responsibility for providing integrated Manufacturing and Process Safety services to support and enable ongoing BioProcess Engineering and Manufacturing operations. The Associate Director has responsibility for protecting the health and safety of key stakeholders including employees, contractors, visitors and others affected by Frederick Site Operations and/or tech-transfer operations. This includes assembling 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. The Associate Director has responsibility for participating in developing, recommending and implementing 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. The Associate Director has responsibility for maintaining awareness of advancing process technology, innovations in safe workplace practices and operational practices which impact employee safety and health, the environment, and external perceptions of the company. The Associate Director has responsibility for maintaining awareness of changes to applicable regulations and ensures site changes are made to meet regulations including FDA, OSHA and other governing bodies. The Associate Director has responsibility for integrating SHE Services into Site Operations business processes, planning and decision making.
Manages experienced professionals (e.g. engineers, scientists, industrial hygienists) who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.
Policy and Strategy:
Interprets and administers policies, processes and procedures that may affect sections and subordinate work units.
Freedom To Act:
Assignments are defined in terms of activities and objectives. Work is reviewed upon completion for adequacy in meeting objectives.
Decisions have an impact on work processes and outcomes. Erroneous decisions or recommendations or failure to complete assignments normally result in serious delays and considerable expenditure of additional time, human resources and funds.
Interacts frequently with internal personnel and outside representatives at various levels. Participates and presents at meetings with internal and external representatives. Interaction typically concerns resolution of operational and scheduling issues.
Essential Job Functions - Overview:
Provide integrated Manufacturing and Process Safety services to support and enable ongoing BioProcess Engineering and Manufacturing operations. Protect the health and safety of key stakeholders including employees, contractors, visitors and others affected by Frederick Site Operations. 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. Participate in developing, recommending and implementing SHE Strategic Plans and Programs which identify and communicate workplace hazards, remove hazards, and establish engineering and administrative controls (including training support) uniquely matched to the hazards. Maintain awareness of advancing process technology, innovations in safe workplace practices 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 FDA, OSHA and other governing bodies. Integrate SHE Services with other Frederick Site Operations strategic efforts, as well as, AstraZeneca. Work closely with Site Leadership Team to implement key initiatives. Support the long term plans for Frederick through participation in Site Master Plan development process and Capital Planning activities. Provide SHE consulting support on capital projects during planning, design and construction phases of the project.
Manufacturing & Process Safety:
Identify, develop and implement Manufacturing and Process Safety Programs designed to address site-specific requirements in cGMP areas within BioProcess Engineering and Manufacturing. Lead development and hand-off of Tech Transfer Pre-Mobilization Safety Assessment to support new products introduced to the Frederick Manufacturing Center (FMC). Develop, implement and lead Industrial Hygiene program to manage risks of exposure to physical, chemical, and biological hazards. 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. Lead hazard and operability studies (HAZOPS) for new and existing equipment and processes to identify and evaluate risks to personnel, equipment, environment and the business. Develop the SHE Product Stewardship process to proactively assess SHE risks and requirements throughout product lifecycle. Ensure the following safety compliance activities are conducted according to site procedures and regulatory requirements: accident and incident investigations with follow up Corrective Action Preventive Action (CAPA) Plans; risk assessments; safety self assessments; indoor air quality (IAQ) assessments; Job Hazard Assessments (JHAs); and compliance training. Develop site-specific Behavioral Safety Program (BeSHE) in alignment with AZ's program aimed at improving safety performance in the Global Operations function. 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. Develop emergency plans and response capabilities and conduct annual exercises to identify improvement opportunities. Chair monthly Safety Committee meeting to identify and address SHE concerns and opportunities with customer groups. Direct site participation in SHE industry benchmarking surveys and present results to senior leadership team.
Contract SHE Services:
Establish 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. Provide input into the development of the 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. Provide input into the development of a contract service provider risk management and mitigation plan, policy and process designed 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. Periodically evaluate the need to change service providers and, where appropriate, 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:
Participate in establishing overall strategic vision and direction for SHE Site Operations. Provide primary interface and guidance to the BioProcess Engineering and Manufacturing Leadership Team on scheduled shutdowns and equipment changeovers, as well as Project Managers on Capital Projects. Periodically seek one-on-one feedback from Site Leadership on performance against expectations. Utilize knowledge and communication skills to change the thinking of or gain acceptance of others in sensitive situations. Provide communications support for SHE cascade meetings. Provide other duties as assigned by the Director.
5+ years experience in Safety, Health and Environmental operations. Minimum 5 - 7+ years' experience in a regulated industry (biotechnology, pharmaceuticals, other). Experience working in cGMP environment strongly desired.
Certificates, Licenses, Registrations:
CSP (Certified Safety Professional), CIH (Certified Industrial Hygienist) and / or PE (Professional Engineer) desirable
Bachelors degree in Engineering, Biology, Chemistry, Physics, Environmental Science, Industrial Hygiene, Occupational Health, 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.