Associate Scientist

POSITION SUMMARY:

- 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, or other group:
- 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 and be met
- 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 (ie 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.

EDUCATION AND EXPERIENCE:

- BS or higher in related scientific field, preferably in an FDA regulated environment.
- Approximately 5-10 years laboratory experience.

TECHNICAL SKILLS AND REQUIREMENTS:

- 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, or other groups.
- Experience with instrumental software, ie Shimadzu Class VP, LC Solutions, Empower Chromatography Data System
- FDA Regulations, Good Laboratory Practices (GLP)