R&D Scientist

R&D Scientist

Duration: 12 Months Assignment

Location: High Point, NC 27265

Job Description

As an Analytical Research and Development (AR&D) Scientist you are expected to independently manage project activities and perform all related administrative. Job functions include providing analytical support to internal, and occasionally external, pharmaceutical product development projects. Duties include, but are not limited to, cleaning verification, method development, validation, qualification and transfer, stability, raw material, finished product testing and partnering with the Formulation R&D team. The perfect candidate will possess the following attributes.

Technical

An expert at developing and validating test methods for pharmaceutical raw materials and finished products for strength, impurities, identity and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis.

An expert at testing pharmaceutical raw materials and finished products by internally developed and compendial test methods.

An expert at troubleshooting analytical and instrument problems and at performing OOS investigations.

An expert at GMPs as they pertain to the R&D analytical group and pharmaceutical product development.

A strong working knowledge of descriptive organic chemistry.

A working knowledge of pharmaceutical formulations development.

Leadership

Will be an experienced technical and personal leader who leads by example.

Will be expected to mentor, lead and develop lower level scientists.

Will effectively maintain open communication within the R&D team, as well as external, customers.

Administrative

Will have a strong command of the English language with strong oral and written communication skills.

Will have a solid working knowledge of, and experience with, common office software and chromatographic data acquisition systems.

Will have experience in providing support for generating CMC sections of INDs, ANDAs and NDAs (including 505b2).

Will be able to effectively work in multidisciplinary teams within the department and company.

Essential Duties And Responsibilities

Ensure that the work performed by direct reports meet pharmaceutical industry and internal company standards for quality and timeliness. Primary duties will include the following.

Develop and validate methods to test pharmaceutical raw materials and finished products for strength, identity, impurities and dissolution performance by commonly used techniques.

Test and release raw materials and finished products in support of internal product development.

Test stability samples in support of internal product development.

Administrate the departmental cleaning verification program to support the Pilot Plant and the packaging lines.

Plan, review and manage the activities performed by direct reports. Such work must meet all appropriate scientific, regulatory and safety standards, including GMPs, ICH, OSHA and internal SOPs.

Accurately, clearly and completely communicate the results of work, orally and/or in writing, to line management, clients and/or others with a need to know.

Work with other internal colleagues and other departments within the company as needed to facilitate the successful development and launch of new products and technologies and assist in trouble-shooting problems with currently marketed products.

Represent the Analytical Development group by participating in departmental and company project team meetings.

Assist in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.

Write SOPs and other instructional documents for the Analytical Development group.

Qualifications (Minimum Education and Experience)

Bachelors, Masters or Ph.D. in Chemistry (a focus on Analytical is preferred) with at least 2-6 years of directly related experience, including at least 0-2 years of directly related supervisory experience.

Other educational qualifications may be considered if accompanied by additional related experience.

Must be fluent in spoken and written English.

Must have a working knowledge of common office and technical software.

Must be legally eligible to work in the United States and must be able to pass a legally administered drug screening.