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Title

R & D Scientist 

Description

POSITION SUMMARY:

A. Successful candidate will be responsible for carrying out analytical method development/validation activities and testing for oral dosage formulations.

B.  MAJOR DUTIES/RESPONSIBILITIES:

Develop and validate analytical methods and perform testing using a variety of technologies including HPLC, UPLC, GC, Dissolution, UV, etc.

Perform wet chemistry and chromatographic analytical activities to support in-house formulation screening and development. Carryout associated stability studies.

Author analytical protocols, development/validation/testing reports, methods, SOPs and submission documents.

Maintain proper instrument calibration status.

Plan and execute projects in support of departmental needs.

Actively participate in the preparation of regulatory submission dossier with focus on CMC module and analytical package.

Independently solve analytical problems and develop solutions.

Comply with company policies and standards

Provide training to individuals in junior positions.

Perform other duties as assigned.

C.  EXPERIENCE/QUALIFICATIONS:

Strong hands-on experience in analytical instruments, such as HPLC, UPLC, dissolution, GC, UV, Empower, etc.

Working experience with analytical method development and validation on API and finish product, prior hands-on experience in analysis of softgel capsules is preferred

Excellent written and verbal communication, a team player

Good knowledge of cGMP, ICH and other FDA or international guidance and regulations. Prior working experience in ANDA/NDA submission package preparation is a big plus

Demonstrate compliance with procedures and policies.

Strong attention to detail

D.  MINIMUM/PREFERRED REQUIREMENTS:

Education:

Minimum B.S. degree in Analytical Chemistry, Biophysical/biochemical sciences, pharmaceutical sciences or related scientific fields required; advance degree is a big plus.

Experience:

Minimum two years of pharmaceutical R&D experience is required.

 
Position Requirements  
Full-Time/Part-Time Full-Time  
Aspire Website www.aspire-pharma.com  
Position R & D Associate  
Number of Openings 1  
Number Filled 0  
Exempt/Non-Exempt Non-Exempt  
Location Aspire Pharmaceuticals Inc.  
About the Organization Aspire Pharmaceuticals is a global leader in soft gelatin manufacturing. Our stringent procurement operations backed with rigorous analytics and testing infrastructure provides custom solutions for our clients from concept to delivery. We are here to guide our clients to innovate better all while optimizing their product journey. As industry trailblazers we are constantly looking to think beyond the status quo.



As a leader in the development and manufacturing of soft gelatin nutritional supplements, we take that role with pride. Our singular vision starts with a question. How can we do it better? This sense of wonder is our driving force to create the highest quality products in the industry. No matter how the process starts, we always go through extensive testing studies, and refinement resulting in a superior encapsulated product.



Innovate. Formulate. Encapsulate. As our mantra suggests we are focused on innovation. We strive to revolutionize soft gel manufacturing and are determined to always be improving our own capabilities- from enhancing our cGMP lab to employing the use of robotics and vision camera inspection on the production floor. As a center of excellence for encapsulation we know how to consistently optimize the process all while providing our clients with the best possible products.

 

This position is currently not accepting applications.

To search for an open position, please go to http://AspirePharmaceuticalsInc.appone.com



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