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Safety Manager II
Ref No.: 19-07770
Location: Allston, Massachusetts
Safety Manager II 
Biopharmaceutical Industry
Allston, MA 02134

Pay: $45.05 / hour
Schedule: 8 hours/day, 5 days/week, 40 hours/week

Join a global biopharmaceutical company committed to healthcare solutions from prevention to treatment.  They turn scientific discoveries into medicine to improve human health.  Every day they dedicate their most important resource, the people, to support patients and families through their health journey.

We are searching for a Safety Manager II who will have the following Key Role and Responsibilities:
  • Responsible for interfacing with all levels of the organization to ensure necessary and sustainable HSE systems, programs, procedures, training, work practices, and controls are developed and implemented to maintain compliance with applicable HSE regulations and address identified risks  
Key Functions:
  • Develop, modify, implement, and maintain health, safety, and environmental (HSE) policies and procedures to maintain compliance and improve HSE performance
  • Conduct Risk and Impact Assessments to drive identification and mitigation of risk
  • Act as an agent of positive change to build an effective HSE culture.
  • Provide subject matter expertise for HSE technical activities.
  • Serves as an in‐house pharmaceutical process expert to support Industrial Development plans for new products, product line extensions and manufacturing site technical transfers of commercial products
  • Oversee technical services activities and engineering at third party manufacturing sites (CMOs) and ensure compliance with Good Manufacturing Practices
  • Interact with North American Industrial Development, External Manufacturing, Regulatory and Quality teams in addition to third party manufacturing sites, and sites outside the US which manufacture all dosage forms including oral dosage, semi‐solids, liquids, injectables and lyophilized for numerous global markets
  • Work with and manage third party technical activities and ensure tech transfer activities are performed according to cGMP
  • Act as the technical expert on all product formulation / process related technical issues and ensure sites adhere to GMP and regulatory guidelines
  • Provide technical support for all products manufactured externally at third party contract manufacturers, North American locations.  Frequent visits to third party sites for batch monitoring are required.
  • Transfer new and existing products from manufacturing sites to others with no interruptions
  • Troubleshoot manufacturing issues and provide solutions leading to product releases
  • Review, execute and support validation activities at third party contractors
  • Work with Regulatory teams to support product submissions to the FDA
  • Ensure the technical support for the Change Control system implemented between organization and the sub‐contractors assuring a relevant management for proposed changes on formulation, processes and equipment
  • Risk Assessment, Health and Safety Programs experience
  • Environmental Regulatory Compliance, Bio/Pharmaceutical experience
  • cGMP

  • Bachelor's Degree