Senior R&D Microbiologist

Description:

Corporate Statement

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.

Position Summary:

· Designs, develops, and validates new products, including, but not limited to, microbiology test method validation, transfer, or verification; procedures, investigations, manufacturing processes, and other non-specified projects or initiatives.

· Identifies resources necessary for R&D projects and assignments and communicates those needs to upper management.

· Participates in R&D department strategic objectives.

Primary Accountabilities:

· Works in a cGMP environment and responsible for generating cGMP data.

· Works with different microbiology techniques, including all quality control test methods.

· Assists the technical team from the beginning through the end of different R&D projects: project triage, scheduling, workload, timeframe, management of external communications, documents, and project closing, etc.

· Defines strategic objectives for the Microbiology R&D department as well as generating and implementing initiatives that improve the department efficiency and the quality of the results.

· Understands and implements FDA/ICH Guidance attending the project needs: method validation, specifications, manufacturing process, etc.

· Designs and conducts new test method development with respect to new products, as well as the development and validation of special microbiology-related projects.

· Conducts the development and validation of special projects as related to Microbiology.

· Drafts, reviews, and/or approves protocols, reports, and/or laboratory notebooks.

· Drafts SOPs related to R&D functions, equipment, documentation, and/or processes.

· Participates in the development and implementation of associated programs (e.g. cleaning, validation, process validation, GMP compliance, equipment validation, maintenance and use, etc.).

· Displays a professional demeanor at all times, including but not limited to, communication with department heads, contract manufacturing clients, and governing bodies, if necessary

· Contributes to other non-specified projects and initiatives of the R&D team as necessary.

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.

Requirements:

Knowledge, Skills & Abilities:

· Regionally accredited Bachelor’s degree in Microbiology or Biological Sciences required, Master’s or above preferred.

- At least 4 years’ experience with microbiological method development, validation, and product development projects.

- 4-5 years of experience working directly with microbiology quality control methods, including bioburden, sterility, and endotoxin testing.

-2-4 years of experience writing and performing method validations.

· Skills to lead technical teams throughout different R&D projects as needed: method development and validation, product development, complex investigations, process development, etc.

· Must possess excellent laboratory skills, problem solving ability, attention to detail, and have an expert understanding of cGMP regulations related to laboratory controls and USP and compendial testing standards.

· The ability and willingness to change direction and focus to meet shifting organizational and business demands.

· Ability to manage oneself effectively, demonstrate integrity, be productive under pressure, and achieve development goals.

· The ability to create new product processes that add value to the Business by generating new ideas and applying creative and methodical approaches.

· Ability to communicate effectively with laboratory staff and management, as well as other departments and external customers under general management supervision.

· Possesses the initiative and follow-through to design, implement, track, and achieve on-time completion of projects independently.

· Must strive for continuous improvement in all work activities.

· The ability to use a multitude of resources effectively and be accurate and current with data and information.

· Position requires bending, typing, climbing, lifting, reaching, vision (20/20), standing (50%), sitting (30%), walking (20%), gripping and hearing.

· Position encounters the following environmental factors: hazardous materials, including flammables and other non-specified hazardous materials, controlled substances, and potential need for sterile gowning.

· Incumbents are required to wear safety glasses, laboratory coat, and other non-specified protective equipment as necessary.

· Salary Range: based on experience.

EEO Statement:

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, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.