MSAT Specialist (Technology Transfer - Upstream)

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: The Manufacturing Sciences & Technology Specialist will provide technical support for internal and external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and provide post transfer support.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Assess manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities; generate facility fit assessments and high level gap assessments.

• Generate and review documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, detailed gap assessments, as appropriate).

• Generate options to resolve technical challenges and present them for endorsement.

• As a person in plant, provide technical support and training of manufacturing personnel to improve understanding of both cell culture and purification operations across the sites.

• Gather, trend, and analyze process generated data; summarize findings in memos and reports and presentations.

• Perform review of manufacturing documentation generated by the receiving unit (manufacturing records, batch sheets, changeover protocols, SOPs, etc.).

• Participate in study teams and investigations (internal and external).

• Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.

• Monitor and prioritize processes and troubleshoot technical difficulties as needed.

• Ensures all tasks are performed in a manner consistent with safety standards and within cGMP guidelines.

• Help to build process knowledge base, controls for technology transfer and knowledge management and lessons learned database; identify continuous improvement activities to improve performance.

• Travel may be required in support of tech transfer activities.

• May involve supervision of lower level specialists.

Knowledge Skills and Abilities:

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Continuously drive to improve processes for improved performance

• Demonstrate respectful behavior at all times

• Ability to multi-task

• Ability to analyze and identify trends

• Develops and delivers effective presentations

• Problem-solving skills

• Ability to train others on basic systems and processes

• Strong written communication

• Ability to work in an ever-changing environment

• Critical thinking skills

Education and Experience:

• Manufacturing Sciences and Technology Specialist requires BS/BA in a scientific discipline or engineering with 2 years of related experience in a cGMP environment, or MS with 1 year experience; biopharmaceutical process development, manufacturing or process engineering experience a plus

• Senior Manufacturing Sciences and Technology Specialist requires BS/BA in a scientific discipline or engineering with 5 years of related experience in a cGMP environment, or MS with 4 year experience or a PhD; biopharmaceutical process development, manufacturing or process engineering experience a plus

Title level (Manufacturing Sciences and Technology Specialist or Senior Manufacturing Sciences and Technology Specialist) will be determined based on skills and experience.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

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