Method Developer / Bioanalytical Scientist

Company Name:
Career Transitions, LLC
The Method Developer / Bioanalytical Scientist is responsible for the development or oversight of the development of methods to quantify chemical entities according to applicable Standard Operating Procedures (SOPs) and/or GxP regulations. This individual demonstrates expertise in the use of instrumentation and laboratory techniques and effectively applies his/her experience and knowledge to participate and lead method development. This individual contributes to the department by working independently, leading others, completing assigned projects on time, participating in process improvement initiatives, and communicating effectively with others. This individual may function as a Principal Investigator or Study Director responsible for the development and execution of validation and sample analysis protocols/plans in accordance with company standard operating procedures (SOPs), industry regulatory guidelines (GxP), and budgetary guidelines.
Duties & Responsibilities
- Communicates effectively with supervisors, colleagues, Principal Investigators, and Study Directors.
- Demonstrates commitment to quality.
- Effectively works in a team and demonstrates a commitment to achieving company goals.
- Efficiently prioritizes assigned daily workload and uses time productively.
- Punctual and reliable attendance according to company policy.
- Adheres to safety procedures at all times.
- Reads, understands, and follows SOPs, safety requirements, regulatory guidelines, and company policies.
- Consistently develops or leads the development of quantitative methods within established timeframes.
- Assists in or leads the completion of laboratory investigations and quality observations, as needed.
- Communicates as needed with external and internal customers regarding scientific issues.
- Leads the development and implementation of new scientific technologies.
- Provides scientific leadership to laboratory staff.
- Functions as a Principal Investigator, Study Director, and/or Contributing Scientist, as assigned.
- Possesses a willingness to perform additional work as assigned by management and as part of the individual-s development plan.
- Demonstrates continuous self-development through acquisition of new skills as determined by management and driven by business need.
- PhD in relevant field and 2-5 years of relevant experience; or
- MS/BS/BA in relevant field and 7-10 years of relevant experience; or
- HS/GED/Associates and 15+ years of relevant experience.
- Proficient using laboratory software applications and LIMS.
- Expert knowledge of GxPs and industry guidance documents.
- 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.
- Familiarity with Microsoft Office Suite.
- Ability to work under specific time constraints.
Some of the benefits provided:
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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