Position Description:

The ProductSupport and Improvement Scientist position at ALPCO has responsibility for designing and supporting analytical programs for raw materials and kit components to ensure they are appropriately characterized.  The position will also involve assisting in the development and implementation of new products and improvements to selected existing products and processes to ensure the methods are well defined, robust, scalable, and economical. The position will also undertake the evaluation of products and assist with the effective transfer of knowledge to manufacturing. The position has extensive interface across the Development and Manufacturing teams, particularly in support of protocol drafting and testing as analytical and QC release techniques and product are transferred.

Responsibilities:

• Understands and develops purification and analytical methods for characterizing proteins and conjugates
• Understands and applies knowledge of a variety of conjugation and plate coating chemistries and develops robust and scalable process methods, applying analytical and problem solving skills, using knowledge and application of established statistical and scientific techniques to design and perform complex experiments and analyze data
• Prepares technical reports and oral presentations detailing procedures, outcomes, and observations
• Applies project management skills and independently manages and organizes work around multiple and evolving priorities
• Applies concepts, practices, and procedures in support of current GMP and ISO regulations, and implements these in support of  product development and transfer processes
• Works collaboratively across departments and teams and trains junior staff
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Skills and Qualifications:

• Education in biology, immunology, biochemistry or chemistry: MS with 5-7, or Ph.D. with  2-5 years experience
• Demonstrated expertise in all aspects of chromatography, protein purification/conjugation, and analytical method development
• Strong analytical and problem solving skills, with demonstrated knowledge and application of established statistical and scientific techniques (Design of Experiments, Statistical Process Control) to design and perform complex experiments and analyze data
• Excellent oral and written communications, facilitation/presentation skills, including preparation of technical reports detailing procedures, observations, and conclusions
• Good project management skills with an ability to manage and organize work around multiple and changing priorities
• Experience in biological sample handling, including blood and other tissues, is required
• Familiar with a variety of the field's concepts, practices, and procedures, including current GMP and ISO regulations, and an understanding of product transfer processes
• Previous product development experience working within a quality system and experience with ELISA products preferred
• Experience in training junior staff is desirable