Job Details
Level
Entry
Job Location
Company Headquarters - Lexington, KY
Position Type
Full Time
Education Level
High School
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.
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:
Responsible for cleaning, sanitizing, operating and maintaining process equipment used during the manufacture of sterile nasal spray drug products and for completing the associated documentation. Duties also include cleaning, organizing and monitoring manufacturing cleanrooms.
Essential Duties:

• Follow Production Batch Records (PBRs) to operate, monitor and control equipment and process parameters during manufacture.
• Follow SOPs to clean, sanitize and prepare process equipment for manufacturing. Follow SOPs to clean and sanitize rooms as required.
• Complete PBRs, Log Books, Forms and other documentation. Assist in compilation and review of lot records prior to submitting to QA.
• Write and revise SOPs and Forms to accurately reflect the current procedures.
• Maintain assigned manufacturing area neat, clean and well stocked with supplies
• Assist with the training of other manufacturing team members.
• Coordinate manufacturing, calibration and maintenance activities with other departments.
• Assist with the writing, execution, and review of validation protocols for manufacturing/support equipment.
• Independently champion manufacturing or facility related improvement projects.
• Participate in the performance routine preventive maintenance on facilities and equipment.
• Help identify continuous improvement and cost savings opportunities.
• Adhere to cGMPs, SOPs, and Safety policies.
• Other duties as assigned.

Candidate Attributes:

• Excellent organizational skills and attention to detail.
• Strong interpersonal and communication skills.
• Motivated to perform work while maintaining a focus on the long-term learning and self improvement.
• Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners.
• Ability to work in a lean, action oriented organization and demonstrate a strong work ethic
• Good written communication skills to read and write SOPs and complete documents.
• Pharmaceutical experience is preferred.
• Experienced with Microsoft Word and Excel.

Qualifications

• High School diploma or GED.
• 0 - 5 years of applicable experience working in a pharmaceutical manufacturing environment.
• Experience with sterilization processes or aseptic technique preferred.
• Good written communication skills to write SOPs and other cGMP documents.
• Qualified to work with controlled substances.

• Strong interpersonal skills and the ability to work well in a team environment.
• Qualified to work with controlled substances.