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Microbiologist

About Imprimis Pharmaceuticals        Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a commercial-stage pharmaceutical company based in San Diego, California. In addition to owning the nation's leading ophthalmology pharmaceutical compounding business, ImprimisRx, the Company holds large equity positions in Eton Pharmaceuticals, Surface Pharmaceuticals and Melt Pharmaceuticals, companies originally founded as subsidiaries of Imprimis. The Company also owns royalty rights in certain 505(b)(2) drug candidates being developed by Eton, Surface and Melt. For more information about Imprimis, please visit the corporate website at www.ImprimisPharma.com   Job Summary Under the leadership of Quality Control Manager, the Microbiologist is responsible for performing routine environmental monitoring, product testing, and raw material testing. The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of microbiology and laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success. Ensures test methods are transferred, qualified/validated, and performed under cGMP requirements. Performs a variety of duties related to the efficient and effective functioning of a Quality Control lab.  Assists in reviews, modifies SOPs and other lab documents as necessary.    Position Responsibilities:    Perform Microbiological testing related to:   o   Bulk Bio-burden  o   API's and Excipients  o   Sterility   o   Endotoxin   o   AET   o   Environmental monitoring   o   WFI System   Perform microbiological testing following laboratory methodology, such as Testing Standard, General Method, Specific Method, Pharmacopeia Compendia, and SOPs. Partner with external testing laboratory to transfer testing methods in-house. Report any non-conformances. Initiate and/or lead resolution efforts and laboratory investigations. Prepare environmental excursion reports, trend analysis and conduct laboratory investigations.  Maintain a clean and safe working environment; adhere to existing safety protocols and participate in department safety programs.  Report results accurately and maintain good recordkeeping.  Partner with internal and external customers to assist in problem solving.  Write protocols and executes the qualification / validation of microbiological assays.  Responsible for routine laboratory upkeep and organization.  Maintain laboratory supplies, media and reagents inventory for QC laboratory.  Adhere to standard operating procedures and good documentation practices to ensure data integrity and traceability.  The ideal candidate is self-driven, and task oriented and can work on their own time but will have to meet deadlines.  Comply with all applicable company, site policies and procedures and all regulatory and FDA guidelines.  Assist in reviews, modifies SOPs and other lab documents as necessary.  Manages preventative maintenance and calibration activities on QC instrumentation.  Experience Requirements and Qualifications:   BS or BA degree in Microbiology or Biology with 5-7 years of relevant microbiology lab experience in a cGMP/FDA regulated industry. Strong interpersonal skills, including the ability to effectively and efficiently communicate in oral and written forms at any level within the organization and interact effectively with customers and external business professional. Ability to work independently or as a team member.  Demonstrated knowledge in Microbiology and aseptic techniques preferred.  Ability to problem-solve and troubleshoot as necessary.  Ability to identify and implement process improvements, implement creative or novel solutions under minimal supervision. Commitment and drive to improve manufacturing operations. Travel Requirements 10% of travel between Imprimis facilities may be required for this position. Position Type and Expected Hours of Work  This is a full-time position working Monday through Friday in Ledgewood, NJ. Occasional overtime and evening hours and/or weekends may be required as per business needs. Work Environment & Physical Demands  While performing the responsibilities of the job, the work environment characteristics are representative of the environment the job holder will encounter, and the physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential functions of the job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions.   The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch. The employee must occasionally lift and/or move up to 50 pounds. May work with hazardous materials and chemicals. Cleanroom environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment.
Salary Range: NA
Minimum Qualification
5 - 7 years

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