External Manufacturing Specialist, Advanced Therapies

About the role

Serving as the operational contact for contract manufacturing and/or partner sites concerning day-to-day activities
Coordination of external manufacturing activities at contract and/or business partner sites, including but not limited to scheduling of all batches, supply of materials, providing direction on shipment of material, tracking and monitoring of cycle times, providing and enlisting support from others who will provide any required associated reports and technical expertise
Functioning as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners
Supporting investigations and associated shipping operations
Supporting and advising critical initiatives and contracts that drive long-term relationship stability and success
Ensuring product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers and business partners.
Performing reviews of pre-production master batch records and executed batch records

Responsibilities

• Serving as the operational contact for contract manufacturing and/or partner sites concerning day-to-day activities
• Coordination of external manufacturing activities at contract and/or business partner sites, including but not limited to scheduling of all batches, supply of materials, providing direction on shipment of material, tracking and monitoring of cycle times, providing and enlisting support from others who will provide any required associated reports and technical expertise
• Functioning as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners
• Supporting investigations and associated shipping operations
• Supporting and advising critical initiatives and contracts that drive long-term relationship stability and success
• Ensuring product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers and business partners.
• Performing reviews of pre-production master batch records and executed batch records

Requirements

• BS/BA in scientific field and the following amount of related experience in cGMP manufacturing operations (clinical and/or commercial), or equivalent combination of education and experience, for each level:
• Associate Specialist: 0-2 years
• Specialist: 2+ years

Qualifications

• You have experience in any of the following areas:
• synthetic-based processes, small molecule synthesis, antibody drug conjugates, fermentation
• You have knowledge of bulk manufacturing techniques (recommended): fermentation, chemical synthesis, downstream purification, conjugation and/or formulation
• You have basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines, and EU regulations

Skills

• Strong interpersonal, written, and oral communication skills
• Resilience and flexibility in the face of a dynamic environment

Benefits

See details in the job description above.

Pay

$62,355.00 - $110,000.00 annually

Schedule

Monday-Friday, 8am-4:30pm