The Development Associate II participates in activities to support research and new product development. The position performs experiments as directed by Scientist or Manager.
ESSENTIAL FUNCTIONS: • Conducts and executes experiments and validation protocols • Collects and summarizes experimental data, draws conclusions, and makes recommendations • Resolves product performance issues • Conducts research, process development, validations, creation and implementation of documentation • Maintains project documentation and detailed and organized laboratory notebook records in accordance with internal company and external regulatory requirements as part of the design control process • Assists in developing raw material, in process and product specifications • Assists in developing QC standards and test methods • Supports simple experiments and validation protocols and supports problem solving or trouble-shooting activities under the guidance of a scientist or manager • Performs data analysis and interpretation and makes recommendations through experimental reports • Participates in team environments and interacts with team members professionally • Maintains good communication with supervisors and peers • Works on problems of a diverse scope and solves technical problems encountered in routine procedures • Maintains a safe working environment • Carries out duties in compliance with established business policies
INTERACTIONS:
Interacts with Manufacturing, Inventory Control, QC, Purchasing, Engineering, Document Control and other resources as needed under the direction of supervisor/scientist.
WORK ENVIRONMENT:
Combination of laboratory and office environment
PHYSICAL DEMANDS:
The work environment characteristics are representative of both an office and laboratory environment and include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Position requires ability to lift up to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.
Education and Experience • BS/BA or equivalent in life sciences or chemistry and skills associated with 2-5 years of experience required or MA/MS in life sciences or chemistry with 0-2 years of experience
Knowledge/Skills • Background in chemistry, biochemistry, molecular biology, virology, immunology, or related field required • Specific technical skills and/or educational background as defined by management based on anticipated and approved projects in agreement with strategic company goals and objectives required • Knowledge of assay development, process development, problem solving, and statistical experimental design required • Ability to train others and participate in new technology transfers required • Ability to complete activities per communicated timelines • Good organizational skills and an ability to perform multiple tasks simultaneously required • Good verbal and written communication skills required • Professionalism and maturity and display of a desire to succeed, be motivated and proactive required • Working knowledge of analytical tools used in Chemistry, Biochemistry, or Immunoassay Development required • Understanding of GMP and ISO 13485 quality system regulations preferred • Demonstrate willingness and ability to work cross-functionally in other areas preferred • Desire to actively seek out new, job-related responsibilities and learning opportunities required