Senior/Principal Engineer (Drug Product Technology)

Location
Rensselaer, NY, US
Posted
Mar 05, 2018
Ref
12444BR
Required Education
Bachelors Degree
Position Type
Full time
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: Support formulation, development, industrialization, troubleshooting and validation at in-house manufacturing and external CMO and partner filling sites.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Performs and reviews product impact assessment for change control and internal/external investigations.
• Reviews and approves process transmittals and manufacturing records.
• Develops and reviews formulation process for manufacturing.
• Monitor changing regulatory requirements, industry standards, and best practices for formulation and filling. Ensure developments are communicated within the company and appropriately implemented.
• Performs and reviews scientific investigations (EOE & DNF), OOS and OOT IPCs as an SME.
• Write product industrialization reports to support technology transfer process.
• Help develop analytical methods for analysis of new molecules.
• Performs hand-on experiments/tests and in-process testing to support process development and product industrialization.
• Develops/writes/plans and reviews protocols and activities for manufacturing support and process validation.
• Presents findings at group and possibly at interdepartmental meetings.
• Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.
• Applies statistical process control tools in monitoring the manufacturing process.
• Create in-process control document for early and late stage programs prior to and post PPQ.
• Supports off-site transfer activities as needed.
• Develops validation procedures reflecting best practices in the industry and provide on the floor support and oversight during process validation campaigns.
• Propose standardization and business process improvements in order to increase efficiency and timeliness.

Knowledge, Skills & 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.
• 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:
• BS in engineering with 5 years industry experience, MS with 4-6 years industry experience, PhD in Engineering with 0-2 years of industry 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.