Director of Microbiology - Decatur, United States - CyberCoders

Description

Decatur, IL Full-time $175, $210,000.00Posted 04/25/2024

Position Overview:

The Director of Microbiology will be responsible for developing and executing strategies to ensure quality of the products manufactured at our facility.

This position will work closely with the Quality Assurance team to meet cGMP and FDA requirements and will also ensure the company meets standards as outlined in European, American and International Pharmacopoeias.

Key Responsibilities:
Develop plans and strategies for the design, implementation, and maintenance of microbial control systems.
Regulate and evaluate environmental monitoring, bioburden, and sterility testing program.
Inspect and validate any microbial cleaning and/or sanitation program.
Ensure the facility meets cGMP, FDA, ISO, AMMI, and other regulatory standards.
Develop and implement tests and procedures to ensure quality of products.
Carry out microbial investigations and remedy any non-conformances.


Qualifications:
Ph.
D. or Masters degree in Microbiology or related field.
Minimum 7 years of experience in a pharmaceutical or biotech environment.
Knowledge of cGMP and FDA requirements.
Excellent interpersonal, communication, and organizational skills.
Ability to work effectively in a team environment.
Strong problem solving and analytical skills.
BenefitsApplicants must be authorized to work in the U.S.Preferred SkillsMicrobiologycGMPFDAEPPharmaEuropean PharmacopiaPharmacopoeiaPharmaceutical BiotechISOAMMI