Manufacturing Sciences & Technology Specialist

Regeneron Pharmaceuticals • Valley, AL

1d • Onsite

About The Position

We are looking for a Manufacturing Sciences & Technology Specialist. This role will provide key technical support for internal and external technology transfer of drug substance manufacturing processes for small molecules, oligonucleotides, peptides, and antibody conjugates. A typical day might include: Leads assessments of manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities; generates facility fit assessments and high-level gap assessments. Coordinate the creation, management, and maintenance during the lifecycle of a transfer. Accountable for generating and reviewing documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, detailed gap assessments, as appropriate). Leads projects and initiatives associated with improving technical support tools for technology transfers. Collaborates with managers to continuously assess and adjust technical support activities and functions. Performs sophisticated, in-depth reviews of technical document content, including FMEAs, PAR reports, regulatory submissions, etc. Leads study teams and investigations during transfers, as applicable. Generates options to resolve technical challenges and present them for endorsement. As a person in plant, provides technical support and training of manufacturing personnel to improve understanding of synthesis, purification, and other related operations across the sites. Captures, trends, and analyzes process generated data; summarizes findings in memos, reports, and presentations. Performs review of manufacturing documentation generated by the receiving unit (manufacturing records, batch sheets, changeover protocols, SOPs, etc.). Helps to build process knowledge base, controls for technology transfer and knowledge management and lessons learned database; identifies continuous improvement activities to improve performance. This role might be for you if you: Work optimally and efficiently in a team-oriented environment to ensure maximum and high-quality output. Have experience interacting with Contract Manufacturing Organizations. You continuously seek to improve processes for improved performance. Can work independently or as part of a team. Are okay with travel up to 10-15% of the time. Can serve as a mentor for lower-level specialists.

Requirements

• BS/BA in engineering or scientific discipline
• Specialist: 2+ years experience
• Sr. Specialist: 5+ years experience
• Work optimally and efficiently in a team-oriented environment to ensure maximum and high-quality output
• Can work independently or as part of a team
• Are okay with travel up to 10-15% of the time
• Can serve as a mentor for lower-level specialists

Nice To Haves

• Higher level degree preferred
• Have experience interacting with Contract Manufacturing Organizations
• You continuously seek to improve processes for improved performance

Responsibilities

• Leads assessments of manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities
• Generates facility fit assessments and high-level gap assessments
• Coordinate the creation, management, and maintenance during the lifecycle of a transfer
• Accountable for generating and reviewing documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, detailed gap assessments, as appropriate)
• Leads projects and initiatives associated with improving technical support tools for technology transfers
• Collaborates with managers to continuously assess and adjust technical support activities and functions
• Performs sophisticated, in-depth reviews of technical document content, including FMEAs, PAR reports, regulatory submissions, etc.
• Leads study teams and investigations during transfers, as applicable
• Generates options to resolve technical challenges and present them for endorsement
• Provides technical support and training of manufacturing personnel to improve understanding of synthesis, purification, and other related operations across the sites
• Captures, trends, and analyzes process generated data; summarizes findings in memos, reports, and presentations
• Performs review of manufacturing documentation generated by the receiving unit (manufacturing records, batch sheets, changeover protocols, SOPs, etc.)
• Helps to build process knowledge base, controls for technology transfer and knowledge management and lessons learned database; identifies continuous improvement activities to improve performance

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level