| Job Description | Position Description:
The Product Improvement Associate position at ALPCO has responsibility for assisting in the development and implementation of improvements to selected existing products and processes to ensure the methods are well defined, robust, scalable, and economical. The position will also involve working in and supporting the manufacturing group to ensure inventory levels are maintained. 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 various departments, particularly in support of protocol drafting and testing as analytical and QC release techniques and products are transferred.
Responsibilities:
Understands and applies knowledge of a variety of conjugation and 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
Understands and can support the establishment of external purification and analytical methods for characterizing proteins and conjugates
Assists in the preparation of technical reports and oral presentations detailing procedures, outcomes, and observations
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 may train junior staff
Skills and Qualifications:
Education in biology, immunology, biochemistry or chemistry: B.S. with 3-7, or M.S. with 2-5 years experience
Recent demonstrated expertise in the development and transfer of robust and reproducible immunoassays for commercial sale
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
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 manufacturing and transfer processes
Previous product development and operations experience working within a quality system and experience with ELISA products preferred
Protein purification, column chromatography and protein conjugation is essential; analytical method development is desirable
Ability to work under tight timelines and perform quick turnarounds is essential
Excellent oral and written communications, facilitation/presentation skills, including preparation of technical reports detailing procedures, observations, and conclusions
Ability to manage and organize work around multiple and changing priorities
Experience in training junior staff is desirable |
| | Company | | Alpco Immunoassays | Job Code | | State or Province | | New Hampshire | | |
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