• Address: Sanford, NC 27331 (map)
• Date Posted: 09/19/09
• Job Type: Full-time

PROCESS DEVELOPMENT SCIENTIST - SOLID DOSE FOR WILSON, NC.
The company will offer a small sign on bonus to assist with relocation most likely up to $10k grossed up. Salary Range is $90k to $100k.

CANDIDATE PROFILE: Experience in solid dose process, tablet coating, compression and encapsulation. 5 years experience. Company prefers a BS/MS degree in chemistry or chemical engineering.

JOB DESCRIPTION

Job Title: PROCESS DEV SCIENTIST IV – Technical Operations

SUMMARY
* The process development scientist is directly responsible for the management and execution of Commercial Product support projects in the areas of product technical transfer, process improvement and optimization, scale-up, troubleshooting, and investigation support. Identifies and evaluates critical process parameters.
* Conducts studies, write protocols and reports in support of process validation activities. Designs, develops, and conduct studies to produce robust bio-equivalent formulations and processes.
* Conducts analyses, writes reports to support filings, scale-up scientific papers and justification for changing processes. Responsible for transferring to Process Validation a robust, validable formula and process to meet requirements of the Code of Federal Regulations.
* Assists in development of process validation strategy for newly identified critical steps. Documents samples and test results.



RESPONSIBILITIES

* Leads multiple projects for troubleshooting, process optimization and technical transfer activities. Provides direction to lower-level staff members. Viewed as technical resource in process development, troubleshooting, process optimization, and scale-up. Reviews the work of less experienced resources and resolves problems.
* Establishes procedures and specifications. Writes and reviews reports and regulatory documents. Utilize statistical experimental design techniques.
* Performs root cause identification of product related investigations. Manages alternate source projects for Active Pharmaceutical Ingredients (API’s). Performs troubleshooting activities for daily support of manufacturing relating to process and equipment.
* Leads product transfer projects, transferring specific products to regular production at local site from an alternate manufacturing site or from on-site Product Development function.
* Provides assistance/guidance to lower level scientists and technical staff.
* Provides off-hour on-call support to manufacturing.
* Documents findings, authors reports and regulatory documents.
* Requires significant interaction with other functional groups within the site.
* Works under limited supervision of management and/or teams leads.
* Understands company goals and objectives and applies them when resolving a variety of problems
* Uses judgment, creativity and sound technical knowledge to obtain and recommend solutions



SUPERVISORY

* This position has no supervisory responsibility.
* Has basic understanding of technical concepts required for specified field. Uses that knowledge, creativity, and company practices and priorities to obtain solutions to complex problems. Interfaces with senior management to provide and obtain information. Possesses working knowledge of statistical analyses techniques for process
* control and data analyses. Possesses applied knowledge of analyses of critical process steps.
* Project Management Skills; Possesses applied knowledge of root cause analysis and troubleshooting techniques;
* Ability to utilize statistical experimental design techniques; computer skills – Microsoft Office proficiency; Strong verbal and written communication skills; Strong customer / quality focus; Technical competence / writing skills;
* Ability to work well independently or in a team environment.

EDUCATION
Minimum BS degree in scientific, engineering or life sciences area. 5-8- years with BS; 3-6 years with MS; 0-3 year with PhD or JD.