Microbiology Manager


Job ID 18-00123

Industry Pharma

Job Type Contract

Location Somerset, NJ

Description

SUMMARY:
Manages, plans, coordinates, directs, and evaluates all activities associated with the Microbiology Laboratory.  Ensures microbiological testing is performed and in compliance with USP, FDA regulations, guides, guidelines, ICH, ISO, and other regulatory requirements.  Manage, direct, and mentor QC Microbiology staff.
ESSENTIAL FUNCTIONS:
Include the following. Other duties may be assigned.
•    Responsible for overseeing all functions as performed by the Microbiology Laboratory.
•    Drafts, reviews, updates and approves laboratory Quality Systems, validations, test methods, specifications, and SOPs.
•    Reviews laboratory logbooks, notebooks, and documentation as it pertains to the Microbiology Laboratory.
•    Oversees and/or purchases laboratory equipment and necessary supplies for the laboratory.
•    Investigates sterility test positives and "Out of Specification” (OOS) occurrences according to company procedures.
•    Responsible for cGMP compliance and continuous quality improvement in the laboratory.
•    Develop and revise as necessary, a Microbiology organization structure that is efficient and supports the business needs under management guidance.
•    Recruit, develop, train, and mentor staff such that they have the education, training, experience, or any combination thereof to perform their job functions.  This includes succession planning.
•    Inspects and releases sterility, biological indicator, bioburden, and environmental tests.
•    Has an understanding and knowledge of the following:
- Sterility Testing by Membrane Filtration, Direct Inoculation, Anti-Microbials, identification of organisms, use of  disinfectants and lethality studies
- Bacteriostasis/Fungistasis Testing and Population Determination and testing of Biological Indicators
- Bioburden determination of Formulated Product, 
- Total Heterotrophic Plate Count of City Water and Process Water
- Preparation, Sterilization, Incubation, and Growth Promotion of culture media
- Bacterial Endotoxin Testing, Verification of Lysate Sensitivity, and Certification of Endotoxin Potency
- Microbial Limit Testing
- Antibiotic Microbial Assays for Potency Determination
- Preservative Effectiveness Testing
- Container Closure Integrity Testing
- Environmental Monitoring Programs including the use of Contact Plates, Settling Plates, and Air Samplers.
- Operation and validation of autoclaves and dry heat ovens
- Temperature mapping of Incubators, refrigerators
ADDITIONAL RESPONSIBILITIES:
Carries out managerial responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, planning, assigning and directing work, performance appraisals, rewarding and disciplining employees; addressing complaints, and resolving problems.  



Qualifications

QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE:
Bachelors degree (B. S.) in Microbiology or Biological Sciences from a four year college or university; minimum of 4 years experience in a microbiology lab of pharmaceutical manufacturing of sterile dosages and at least 2 years of Supervisory/Managerial experience preferably in the biotech/pharmaceutical industry. 
JOB PREREQUISITES:
•    Ability to meet attendance standards.  All full-time employees are required to work a 40-hr week.  At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
•    Must have knowledge of current Good Manufacturing Practices specializing in sterile dosage forms, USP testing requirements for sterile product and Microbiological procedures, CFR, and other FDA regulations /guidelines.
•    Must have a team work attitude. 
•    Will interact with all functional departments within the company including hourly, professional and management personnel. 
•    Must be detail oriented and exhibit strong interpersonal, organization, and communication skills 
•    Must have accomplished computer skills such as Microsoft Office.
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT
Requires prolonged sitting and standing. Requires eye-hand coordination and manual dexterity sufficient to operate microbiological equipment, keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision to record, prepare and communicate appropriate reports. Will come in contact with hazardous materials. Employee is expected to work with them in a safe manner and use all safety precautions.
Mental requirements include:
- Ability to apply deductive reasoning and understand complicated issues.
- Ability to receive instructions and follow work rules and company policies.
- Ability to follow safety and security practices.
- Ability to meet deadlines and effectively deal with office stress.
- Ability to accurately communicate ideas, facts and technical information.
- Maintain confidentiality of certain information.