Kindeva Drug Delivery
Kindeva Drug Delivery is a leading global contract developer and manufacturing organization (CDMO) with delivery platform experience expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch, and Nasal Spray Technologies. The Lexington location develops, manufactures, and commercializes prescription nasal spray products and is experiencing increasing continuous growth. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture more tomorrows. If you are ready to work for a purpose, join our team!
Compensation and Benefits: This is a full-time, salaried position with a competitive compensation package including benefits such as health insurance, 401(k) plan, paid time off, and opportunities for career growth.
Job Summary: The manufacturing technician is responsible for cleaning, sanitizing, operating, and maintaining process equipment used to manufacture sterile nasal spray drug products and for completing the associated documentation.
Description:
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 clean rooms.

• 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, Logbooks, 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.
• 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:

• BS in a scientific discipline or equivalent experience.
• 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.

California residents should review our Notice for California Employees and Applicants before applying.
Covid-19:
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.