Associate Scientist

Responsibilities-

• Develops, and directs, and performs, lab activities related to experiments, studies, and projects in support of production, laboratory, or other groups 

• Researches sufficient information from all sources to fully understand study and needs.

• Uses proper study design to effectively utilize resources to accomplish objectives

• Plans studies, including timeline to follow and strategy in alignment with project objective o Compiles, analyzes, and interprets data leading to reports with conclusions and recommendations to appropriate personnel

• Understands and follows GMP/GLP regulations.

• May supervise non-exempt and contract personnel to achieve above goals.

• Will work with senior scientific or management staff on major studies assuming scientific and GMP responsibility for a portion or portions of the study. Includes cross functional and cross site teams

• Keeps abreast of technological advances specific to the laboratory and adopts and develops new techniques or scientific methods based on findings.

• Provides instrumentation support for maintenance and trouble shooting. Develops and Manages the PM program for laboratory instrumentation.

• Provides support and coaching for technology and method transfers

• Maintains Standard Operating Procedures and recommends/validates/qualifies new methods and procedures for the laboratory.

• Provides recommendations, conclusions and direction based on the data obtained from studies.

• Completes Validation/Qualification methodology process reviews/verifications with support of compliance and/or re-validation requirements.

• Provides support on all IOQ/PQs for laboratory instrumentation including document generation and IOQ/PQ completion.

• Serve as Systems Administrator for Laboratory Computer systems, i.e. Empower 3, Omnic, LIMS.

• Maintains a safe and clean working area.

• Ability to communicate with-in department, with vendors, contractor sites and/or external customers for administrative and technical information.

• Ability to prepare reports of experiments or studies that are grammatically and technically ready for regulatory audit.

• Ability to construct and format reports for the intended audience (i.e. FDA, Production, Laboratory, Customers, or Sales).

• May support FDA filings, assisting in compiling FDA responses, annual compliance reports, provide review for regulatory submissions.

• May support release of API and finished goods including technical review of laboratory records, and COA generation and/or approval.