Research and Development Director jobs in Columbia, SC

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:

· Design, Development, and Validation of New Products, including, but not limited to, analytical test method validation/transfer/verification, de-formulation, new formulation, procedures, investigations, manufacturing process, and other non-specified projects or initiatives.

· Use the Quality by Design concepts and tools during the product and analytical method development projects.

· Assists with additional work duties or responsibilities as evident or required.

· Performs other duties as assigned or apparent.

· Participate in the definition of the R&D department strategic objectives.

· Technical team leader for the R&D department.

Primary Accountabilities:

· Capable of working in a GMP environment and responsible for generating GMP data.

· Capable of working with different analytical techniques like HPLC, UPLC, LC/MS, GC, GC/MS, Osmometer, Automatic Titrator, pH Meter, etc.

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

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

· Capable of understanding and implementing the FDA/ICH Guidance attending the project needs: method validation, specifications, impurities, genotoxic impurities, residual solvent, leachable, product development, manufacturing process, etc.

· Responsible for designing and conducting new product development with respect to formulation, development of analytical techniques, small scale laboratory formulation, and early to end phase process development.

· Responsible for conducting the development and validation of analytical methods for pharmaceutical ingredients and dosage forms, including establishment of specifications.

· Capable of implementing the Quality by Design concepts and tools during product, process, and analytical development projects.

· Responsible for drafting, reviewing, and/or approval protocols, reports, and/or laboratory notebooks.

· Responsible for evaluating new raw materials and components for quality and safety prior to implementation into exhibit batches and GMP production.

· Responsible for drafting SOPs related to Quality Control and Research and Development functions, equipment, documentation, and/or processes.

· Draft initial release specifications for materials, products, and components intended for use in a GMP environment.

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

· Contributes to other non-specified projects and initiatives of the Research and Development Group as necessary.

· Contributes to the Research and Development Stability Program 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.

Knowledge, Skills & Abilities:

· Regionally accredited Bachelor Degree required, Master or above preferred o Ph.D. Analytical Chemistry

o At  least  4  years  of  experience  with  analytical  method  development  and validation and product development projects.

o 4-6 years of experience  working directly with  HPLC, UPLC, LC/MS, GC, and/or GC/MS.

· MA/MS Analytical Chemistry

o At  least  6  years  of  experience  with  analytical  method  development  and validation and product development projects.

o 6-8 years of experience working directly with HPLC, UPLC, LC/MS, GC, and/or GC/MS.

· BA/BS in Chemistry

o At  least  8  years  of  experience  with  analytical  method  development  and validation and product development projects.

o More than 8 years of experience working directly with HPLC, UPLC, LC/MS, GC, and/or GC/MS.

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

· Expert in the theory of and in conducting analysis by HPLC, GC, FT-IR, UV/Vis spectroscopy as well as wet chemistry techniques,  needing no guidance.

· Must possess excellent analytical skills, problem solving ability, attention to detail, and have an expert understanding of cGMP regulations pertaining to laboratory controls and USP and compendia! Standards.

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

· The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.

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

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

· Position  requires  bending,  typing,  climbing,  lifting,  reaching,  vision  (20/20),  standing  (SO%),

o sitting (30%), walking (20%), gripping and hearing.

· Position encounters the following environmental factors: hazardous materials including Acids, Bases, Oxidizers, Corrosives, Flammables and other non-specified hazardous materials that are project specific.

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

· Additional Requirements:

· 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.