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Sr. Project Manager / Bioanalytical

Company Name:
Career Transitions, LLC
Project Manager needed in a permanent job position who will assist in the development and execution of bioanalytical validation and sample analysis protocols/plans in accordance with company standard operating procedures and industry regulatory guidelines (GxP).
Responsibilities
- Assist the Principal Investigator in laboratory management of clinical and pre-clinical bioanalytical studies as an Associate Study Director/Associate Principal Investigator per GxP requirements
- Draft bioanalytical method validation protocols, study plans, and with minimal supervision complete data interpretation of study reports
- Provide accurate and timely project status/updates to management and to external customers
- Attend study meetings, review draft protocols, and study budgets
- Work closely with laboratory staff to ensure project timelines are met
- Perform management review of bioanalytical data and communicate trends or anomalies in data
Requirements
-BS/BA or PhD in related field required
-Minimum 5-7 years (B/S) or 2 -5 years (PhD) in a related field
-Experience with Watson LIMS and AB Sciex Analyst for the generation of data, data summaries and reports
-Expertise with liquid chromatography techniques and their application to bioanalysis and LC-MS/MS data
-Expert knowledge of GxPs and applicable industry guidance documents Prior experience in a regulated environment.
- Ability to work extended hours beyond normal work schedule to include, but not limited to, evenings,
weekends, extended shifts and/or extra shifts, sometimes on short notice.
-Proficiency with Microsoft Office Suite.
-Ability to work under specific time constraints.
Benefits at a Glance
Two choices of medical coverage, including prescription drug and vision coverage
Two choices of dental coverage
Medical and dependent pre-tax flexible spending accounts
Paid time off bank and holidays
Retirement savings plan - 401K plan with company matching on employee contributions
Short/Long term disability plans, voluntary life insurance, and company paid life insurance
Tuition reimbursement program
Employee assistance program

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