Development Associate II

DESCRIPTION

Responsibilities include activities to support research and new product development.

• Perform self-directed experiments or as directed by Scientist or Manager

• Resolve product performance issues

• Summarize experimental data, draw conclusions and make recommendations

• Conduct research, process development, validations, creation and implementation of documentation and training of personnel

• Maintain project documentation and laboratory notebooks in accordance with internal and external regulatory requirements as part of the design control process • Maintain a safe working environment

ESSENTIAL FUNCTIONS

➢ Plan and execute experiments and validation protocols, supports problem-solving and trouble-shooting activities with minimal guidance from manager. Data analysis, interpretation and recommendations through experimental reports

➢ Maintain detailed and organized notebook records

➢ Participate in team environments and interact with team members professionally. Trains others as needed.

➢ Other: Maintain good communication with supervisor and peers, maintain safe working environment, training, carry out duties in compliance with established business policies

INTERACTIONS Interacts with Manufacturing, Inventory Control, QC, Purchasing, Engineering, Document Control and other resources; provides updates to management/project teams; prepares and presents technical data.

EDUCATION/EXPERIENCE

➢ BS/BA or equivalent in life sciences and typically 2-5 years’ experience or MA/MS in life sciences plus 0-2 years’ experience.

SKILLS

➢ Background in chemistry, biochemistry, molecular biology, virology, immunology, or related field

➢ 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

➢ Knowledge of assay development, process development, problem solving and statistical experimental design.

➢ Able to train others and participate/coordinate new technology transfers

➢ Excellent organizational skills and an ability to perform multiple tasks simultaneously

➢ Excellent communication skills (verbal and written)

➢ Must exhibit professionalism and maturity and display desire to succeed, be motivated and proactive

➢ Working knowledge of analytical tools used in Chemistry, Biochemistry, or Immunoassay Development

➢ Working knowledge of GMP and ISO 13485 quality system regulations

➢ Demonstrate willingness and ability to work cross-functionally in other areas

➢ Desire to actively seek out new, job-related responsibilities and learning opportunities

➢ Appropriate computer skills (e-mail, graphing software, word processing) Works on complex issues and must be able to solve technical problems with assistance on non-routine procedures; may determine methods and procedures on new assignments and provide minimal guidance to lower level employees. Individual must be able to complete activities per communicated timelines.