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Principal Specialist, Drug Product Process Sciences

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, NY, United States
Start date
May 1, 2019

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Discipline
Clinical, Clinical Medicine, Engineering
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

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: Guides laboratory activities for the design and development of robust drug product processes that enable the delivery of life transforming medications to patients globally. The individual will guide and/or perform laboratory studies to optimize drug product unit operations from freeze/thaw through filling and inspection and will be part of a team responsible for industrialization, troubleshooting, and validation of drug product processes at manufacturing sites, both international and domestic.

Essential Duties and Responsibilities:

• Lead efforts to perform drug product process unit operations in a laboratory setting and provide recommendations to cross-functional teams. Collaborate with cross-functional teams to define and execute drug product process development and technology transfer activities.

• Provide practical guidance in the development of laboratory plans for drug process product development. Guide the execution of such plans and participate directly as needed. Ensure data quality, provide expert troubleshooting, and train and develop skills of junior staff.

• Build and maintain relationships with relevant equipment and technology vendors. Establish relationships with vendor technical staff to enable rapid execution and/or troubleshooting of laboratory operations.

• Author technical memos. Co-author or contribute to documents and reports authored by cross-functional teams. Act as a reviewer for documents containing laboratory data.

• Support primary component selection and design by guiding laboratory investigations of container and closure performance under a variety of conditions.

• Support product life-cycle initiatives.

• Support process investigations and assist with product impact assessment for change controls and internal/external investigations, primarily through laboratory investigations and data analysis.

• Continuously drive to improve processes for improved performance

• Other duties assigned by manager

• Up to 20% Travel may be required

Knowledge, Skills, and Abilities:

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Ability to maintain integrity and honesty at all times

• Continuously drive to improve processes for improved performance

• Demonstrate respectful behavior at all times

• Accountable for technical performance and results of team

• Manage internal and external relationships

• Develop strategy and create metrics to measure effectiveness of strategy

• Translate ambiguity into actionable steps

• May manage others through influence rather than direct authority

• Ability to resolve conflicts and coach others on problem solving

• Handle issues appropriately and with a sense of urgency

• Prioritize based on business needs

• Identify and effectively communicate risks

• Ability to problem solve and identify root cause

• Ability to communicate at all levels and across various functions

.

Education and Experience:

• Principal Specialist: BS in chemistry, physics, biology, biochemistry, mathematics, or other natural or technical science with 8+ years industry experience; MS with 7+ years industry experience.

• Staff Specialist: BS in chemistry, physics, biology, biochemistry, mathematics, or other natural or technical science with 10+ years industry experience; MS with 9+ years industry experience.

• Experience in a diverse array of laboratory activities preferred.

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.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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