Supervisor, Microbiology at Cosette Pharmaceuticals in North Carolina

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.

Innovating every day.™

Basic Purpose: To manage and supervise a group of Microbiologists and technicians in a Quality Control laboratory setting for supporting non-sterile production of Rx and OTC topical creams, ointments, suppositories, and any new pharmaceutical products. Will function in reviewing all Microbial testing on raw materials, components, and finished products for release. To assure all testing complies with USP and cGMP guidelines. To develop new methods for testing, improve existing methods and look for expedited testing with automated instrumentation. To review or write all protocols and SOPs related to QC Microbiology Unit. Function as a liaison among Production, QA, QC, ARMD and Microbiology Unit to assure integrity and quality of Process Validation and Cleaning Validation in compliance with cGMP. To manage and control an effective Environmental Monitoring Program, Compressed Air system and USP Purified Water system for the manufacturing facility in compliance with cGMP. To assist in routine Microbiology audit. To manage, plan, organize the Microbiology Unit with effective administrative and cost effectiveness.

Essential Functions and Responsibilities:

• Establishing, maintaining, and continuous improvement of the Laboratory microbiology programs, policies, SOP’s and metrics.
• Executing day to day activities in support of the microbiology testing including finished product, raw materials, in process tests, environmental monitoring, USP water, R&D validations, etc.
• Act as part of the QC Laboratory Leadership to drive and sustain a culture of quality and work environment.
• Manage the performance to written goals of direct staff. Ensure staff are adequately trained.
• Lead related project work including writing protocols, reports, investigations, CAPA, etc.
• Plan and forecast microbiology activities to a schedule with accurate communication to stakeholders. ****

Knowledge, Skills, Qualifications and Physical Requirements:

The following describes the general knowledge, skills, qualifications, and physical requirements normally associated with performing the essential functions of this job. In compliance with law Cosette Laboratories will consider varying or modifying these standards to provide individuals with disabilities an equal employment opportunity.

Education/Training/Work Experience:

• A BS degree or higher in Microbiology, chemistry or other related science or technological field.
• A MS degree or higher in Microbiology, Engineering, chemistry or other related science or technological field.
• Minimum of 10 years experience executing microbiology testing including cleaning validations, USP water, environmental monitoring, Finished Product Testing, and Method Validations.
• Minimum of 5 year supervising related activities and staff. ****

Specialized Knowledge and Skills:

• Familiar with various microbiology methods and equipment.
• Ability to trouble shoot methods and equipment
• Technical Writing of Protocols, SOPs, Reports, CAPA, etc

Work Environment and Physical Demands (List required PPE’s):

• Wear appropriate PPE safety glasses, gloves, and a lab coat.
• Ability to wear respirator when required.
• Ability to occasionally lift 50 pounds.