MSAT Lead

JOB SUMMARY

Lead technological transfer process for internal and external processes to manufacturing.  Work with Process Development (PD), Supply chain and Manufacturing teams. A successful candidate will work closely with Project Managers, Process Development, Supply Chain, Quality Assurance, and Manufacturing to ensure new processes are transferred from clients to Operations with emphasis on scalability, transferability, and robustness.  

ESSENTIAL JOB FUNCTIONS

• Ensure overall project success, identifying and tracking progress against key project milestones
• Team serves as point of contact with internal and external stakeholders for viral vector project technical transfer
• Manage team of technical writers and tech transfer SME’s
• Actively lead and manage knowledge transfer activities between internal and external stakeholders and process development team
• Collaborate with operations and testing lab to complete process transfers and qualification of analytical programs
• Ensure clear commitment and alignment between cross functional technical teams
• Maintain organized project resources for drafting production procedures, and materials specifications
• Work with PD, QC, supply chain, manufacturing, QA to identify and mitigate risks to manufacturing in early phase of the new product development process
• Be able to source all necessary information to the technical writing team for generation of master batch records and Bill of Materials
• Owner of technical transfer document creation and completion
• Deliver comprehensive technical transfer reports to clients and for internal use
• Author, utilize, and train employees on a wide variety of written procedures, including batch records and operating procedures
• Support regulatory filings and justifications as a member of the technical regulatory response team
• Provide post-launch manufacturing/QC support
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies by your direct reports

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision, and ability to adjust focus. 
• In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.