Associate Scientist

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.

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 within 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