Microbiology R&D Analyst I
Nephron Pharmaceuticals Corporation is a privately owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron’s products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmics, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.
As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. Nephron is currently working on research and development projects that include over 50 new products. The company’s longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long term care facilities. Nephron has a sales force that covers all fifty states and Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone.
- Performs research and develops projects for both established and new products, including, but not limited to, microbiological test method validation/transfer/verification, procedures, investigations, and other non-specified projects or initiatives.
- Plans, organizes, and manages resources on method validation projects to assure technical quality and schedule adherence.
- Performs other duties as assigned or apparent.
- Works with different microbiological techniques and equipment, including but not limited to gram stain, turbidimetric endotoxin testing, liquid particle counter, isolator, bioburden, filtration analysis, sterility testing, aseptic process simulation, and MALDI-TOF.
- Performs different microbiological tests for R&D Microbiology and QC Microbiology, as needed; also understands and performs routine investigations related to Environmental Monitoring and laboratory testing.
- Works in a GMP environment and responsible for generating cGMP data.
- Plans and executes research and test method development projects for both established and new products.
- Participates in development and implementation of associated programs (e.g. cleaning validation, process validation, cGMP compliance, equipment validation, maintenance and use, etc.), as well as generating trending reports for cleanroom environments.
- Participates in reading and documenting media fill results.
- Works in a cGMP environment and is responsible for generating cGMP data.
- Ensures reports, submission documentation, and development summaries documenting the product development process are available for clients, partners, and health authorities (i.e. FDA).
- Assists in drafting R&D and QC protocols, summary reports, and studies.
- Communicates Microbiology-related observations, issues, problems, discrepancies, and any violation of company policies or procedures to R&D Microbiology Manager, Assistant Director of Microbiology, Director of Microbiology, or designee.
NOTE: The primary accountabilities above and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.
Knowledge, Skills & Abilities:
· Regionally accredited Master’s Degree in Microbiology or other science-related field
o Minimum of 1 - 3 years of previous experience in cGMP-related environment preferred.
· Highly skilled in conducting microbiological analysis such as identification, morphological analysis, endotoxin testing, and etc., requiring little or no guidance.
· Strong understanding of general microbiological processes and testing.
· Strong interpersonal, verbal, and written communication skills; effective organization, multi-tasking, and problem solving skills.
· Should be certified to enter aseptic environments around the facility, including ISO 5.
· Great communication, documentation, and time management skills required.
· Demonstrates the ability to perform all testing for the Quality Control portion of the Microbiology Lab.
· Proficiency in programs used by the Microbiology Laboratory such as LIMS and MODA.
· Become certified to enter aseptic environments around the facility including ISO 5.
· Computer experience (Microsoft Word, Excel, Power Point)
· Specific expertise, skills, and knowledge within research and product development gained through education and/or experience.
· The ability and willingness to change direction and focus to meet shifting organizational and business demands.
· The ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals.
· Possesses the initiative and follow through to implement, track, and achieve on-time completion of projects, as assigned by management.
· Must strive for continuous improvement in all work activities.
· The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally and leverages diversity.
· Position requires typing, climbing, lifting (up to 15lbs), reaching, vision (20/20), standing (10%), sitting (90%), walking, and hearing
· Additional Requirements: As needed
- Salary range: Based on experience
Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.
Nephron Pharmaceuticals is a drug free workplace.