Manufacturing Manager in Lexington, KY

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.

MUST HAVE:

5-7 years of experience in a manufacturing role in pharmaceutical manufacturing
process development, process engineering optimization, and validation.

Relocation Assistance Offered
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
professional development.

Job Summary:

If you are ready to work for a purpose, the Manufacturing Manager position is a
crucial role that oversees the manufacturing operations team during the process of manufacturing
products, performing scale-up and validation activities and preparing for commercial launch of nasal
spray drug products ensuring that all products are produced efficiently, safely, and in compliance
with regulatory standards in an FDA regulated cGMP pharmaceutical manufacturing environment.
Position Responsibilities:
Oversee the day-to-day operations of the manufacturing department, including scheduling,
resource allocation, and quality control.
Develop and implement strategies to increase efficiency and reduce costs in production
processes.
Ensure compliance with all regulatory standards, including cGMP, FDA, and OSHA
regulations.
Hire, train, and manage a team of manufacturing personnel, providing guidance and support
as needed.
Continuously monitor and improve key performance indicators, such as yield, cycle time, and
waste reduction.
Manage inventory levels and ensure that materials and supplies are ordered and received on
time.
Implement and maintain standard operating procedures to ensure consistency and quality in
product output.

Requirements:
Bachelor s degree in engineering, Pharmacy, or a related field.
Strong knowledge of cGMP, FDA regulations, and OSHA compliance. HVAC systems and
cleanrooms, & pharmaceutical processing & plant equipment.
Proven experience in managing people and production processes.
Excellent communication, leadership, and decision-making skills.
Ability to work in a fast-paced, deadline-driven environment.
Attention to detail, strong problem-solving skills, excellent technical writing, communication &
organizational

EEOC Statement:
Kindeva Drug Delivery/Summit Biosciences is an equal opportunity employer and considers all
qualified applicants for employment without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, age, disability, or any other legally protected status. We are
committed to creating a diverse and inclusive workplace and encourage individuals of all
backgrounds to apply.