Job Details
Level
Experienced
Job Location
Company Headquarters - Lexington, KY
Position Type
Full Time
Education Level
4 Year Degree
Travel Percentage
None
Job Shift
Day
Job Category
Pharmaceutical
Description
Summit Biosciences is a specialized pharmaceutical company that develops, manufactures, and commercializes prescription nasal spray products. Summit Biosciences is experiencing significant growth and offers competitive compensation annual bonus, 401k plan, paid holidays, PTO, health/dental/vision/life insurance, short/long term-disability, an incredible collaborative and challenging culture in a team-oriented environment. Second shift hours are 3:00 PM - 11:30 PM.
Summit Biosciences is an Equal Opportunity Employer. Summit Biosciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by applicable federal, state and local laws. All employment is decided on the basis of qualifications, merit, and business need.
Summary:
This individual is responsible for independently performing routine tasks in the QC laboratory under direct supervision.
Essential Duties:

• Perform incoming raw material sampling and testing, component inspection, in-process analyses, finished product release testing and stability testing.
• Maintain the laboratory in accordance with SOPs.
• Calibrate, operate and maintain analytical instrumentation for product testing, including routine preventive maintenance and troubleshooting.
• Write, revise and review Standard Operating Procedures, Material Specifications, Forms, Protocols and Reports.

• Familiar with basic analytical techniques and executes tasks below under supervision or under the direction of a test method, standard operating procedure, or a protocol.
  • HPLC
  • UV/Vis
  • FTIR
  • GC
  • Nasal Spray testing
• Develop method validation knowledge.
• Develop instrument qualification knowledge.
• Develop understanding of cGMPs.
• Develop investigative skills for OOS, OOT and aberrant result laboratory investigations.
• Good oral and written communication skills.
• Recommend and implement as required, innovative approaches to problem solving.
• Other duties as assigned.

Knowledge, skills and abilities:

• Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules.
• Team player with well-developed interpersonal, organizational, and communication skills.
• Maintains proper social etiquette and self-control when dealing with stressful situations.

Qualifications
Qualifications:

• Bachelors in Chemistry or related field with at least 3 years of pharmaceutical industry experience
• Masters degree in Chemistry or related field with at least 2 years of pharmaceutical industry experience
• PhD in Chemistry or related field
• Qualified to work with controlled substances