Lead Scientist, Microbiology

Organization
Catalent Pharma Solutions
Job Location
Morrisville, NC
Job Description

I. Overview
The laboratory groups at are responsible for the support of pharmaceutical product development in a range of dosage forms both directly with customers and in collaboration with other Catalent facilities. This includes formulation development, structural chemistry, analytical support and clinical trials material manufacturing.
II. Department Summary
As a member of the microbiology team, you will utilize your expertise to support method development, method suitability and testing in support of the pharmaceutical industry. Your efforts will focus on delivering high quality technical support to the development and execution of microbiological methods such as Microbial Enumeration, Sterility in a barrier isolator, Endotoxin, Antimicrobial Effectiveness, Container Closure Integrity and non-routine microbiological assays. You will serve as a mentor to junior analysts contributing to their microbiology training and development. You will apply your experience and expertise to author microbiology Standard Operating Procedures and analytical methods. As a scientist and leader in our organization you will be a key component of the engine that powers our operation, applying your microbiological expertise. 
A high level of expertise with Microbial Enumeration, Endotoxin and Sterility testing in a barrier isolator is required. Experience working in a highly GMP-regulated environment is required. Additional experience with endotoxin, AET, TOC, CCI, authoring SOP's, laboratory investigations and training/mentoring is also preferred.
III. Job Summary
The Lead Scientist works with minimum supervision, conferring with superior on unusual matters. He/she is usually assisted by laboratory technicians/associates.? He/she demonstrates potential for technical proficiency and scientific creativity through broad assignments. The Lead Scientist has appreciable latitude for unreviewed action or decision. He/she may be responsible for setting and defining technical objectives and assessing results. Comply with divisional and site Environmental Health and Safety requirements.
IV. Specific Duties, Activities, and Responsibilities

•Develop and execute laboratory work plans/schedules for self and junior members of team, using customer milestones and Division/Site performance standards and metrics 
•Authors and may approve technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures 
•Review technical documents for accuracy, thoroughness and regulatory compliance 
•Trains, coaches or mentors others on technical, personal development or business issues 
•Supervises technical staff, including work assignments and performance management 
•Responsible as Project Director on one or more projects, with responsibility for project outcome and customer interaction 
•Develop and execute efficiency improvement projects 
•Identify and recommend business opportunities on project specific basis 
•All other duties as assigned.

Requirements: 

V. Job Qualifications
Education and Experience:

•Degree in chemistry or closely related physical science: Bachelor's degree with 9 - 10 years related experience, equivalent education, experience and training; Master's degree with 6 - 8 years related experience, equivalent education, experience and training; OR Doctorate Degree with 2 - 4 years related experience 

Knowledge, Skills and Abilities:

•Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs ...cont.

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