Principle Mfg Sciences & Technology Specialist

Regeneron Pharmaceuticals

253d • $90,800 - $173,400

About The Position

We are looking to fill a Principal Manufacturing Specialist & Technology Specialist with a Mon-Friday 8:00am-4:30pm schedule. 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.

Requirements

• BS/BA in engineering or scientific discipline.
• 8+ years of experience for Principal Specialist or 10+ years for Staff Specialist.
• Experience in small molecule, oligonucleotide, peptide manufacturing process development, or process engineering is a plus.
• Ability to work independently or as part of a team.
• Experience interacting with Contract Manufacturing Organizations.
• Ability to mentor lower-level specialists.

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.
• Coordinates the creation, management, and maintenance during the lifecycle of a transfer.
• Generates and reviews documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, detailed gap assessments).
• 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.
• Leads study teams and investigations during transfers.
• Generates options to resolve technical challenges and present them for endorsement.
• Provides technical support and training of manufacturing personnel.
• Captures, trends, and analyzes process generated data; summarizes findings in memos, reports, and presentations.
• Performs review of manufacturing documentation generated by the receiving unit.
• Helps to build process knowledge base and identifies continuous improvement activities.

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off for eligible employees

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree