Associate Scientist

• Analyze and/or direct the analysis of routine and non-routine samples without supervision including but not limited to raw materials, in process testing, finished good release and stability testing.

• Coordinates activities associated with production and quality activities.

• Be responsible for approval of analytics associated with quality control testing in the laboratory.

• Trains or mentors others in routine analyses.

• Assists in the development of studies and procedures

• Creates and leads experiments with minimal supervision from management

• Supports the site quality, safety and production needs and goals compliantly

• Assume responsibility for the primary scientist lead at the site

• Familiar with laboratory environment as well as responsible for knowledge of (Veterinarian Master File) VMFs, NADAs, Regulatory Submissions, CFR 211/226 regulations and filing specifications. 

Position Responsibilities-

• Develops, runs/directs, routine lab activities as well as experiments, studies, and projects in support of production, laboratory 

• Gathers sufficient information from all sources to fully understand study, site and/or customer needs, Uses proper study design to effectively utilize resources, Plans studies, including timeline to follow 

• 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

• May 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.

• Maintains Standard Operating Procedures dealing with their work area and recommends new methods and procedures for their area and the laboratory.

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

• Maintains a safe and clean working area, and directs others in same.

• 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 finished goods including technical review of batch records, labelling and COA generation and/or approval. 

• BS or higher in related scientific field, preferably in an FDA regulated environment.

• Approximately 5-10 years laboratory experience.

• 7+ years of experience with GLP

• 1-3 years of experience with FDA regulations

• Excellent attention to detail, excellent written and verbal skills

• Proficient in chemistry and analytical instrumentation including but not limited to HPLC, IC, GC, FTIR and UV-VIS spectroscopy.

• Experience with Wet Chemistry bench methods

• Ability to troubleshoot issues as it relates to methods and equipment/instruments.

• Experience with analytical method development and validation.

• Ability to develop, run/direct, and report experiments, studies, and projects in support of laboratory, customer, validation & production

• Experience with instrumental software, i.e. Shimadzu Class VP, LC Solutions, Empower Chromatography Data System

Regards

Ricky Bansal

732-429-1925