- Independently manage a portfolio of sample analysis projects while ensuring timelines are met in a single operational area
- Independently execute review and approval of data for final scientific/technical decisions within a single operational area
- Full understanding of compliance expectations to independently respond to quality assurance audit observations in appropriate software
- Independently execute the completion of laboratory investigations, assay troubleshooting and quality observations
- Independently perform problem solving for technical and/or regulatory issues
- Responsible for review of study plans/protocols/amendments
- Independently participate in Sponsor visits/tours
- Provide expertise in developing and validating quantitative/qualitative methods/procedures with increased complexity/scope in one operational area
- Independently perform data analysis using appropriate software
- Develop and maintain critical thinking, troubleshooting and time management skills aligned with needs of operational areas
- Demonstrate effective communication skills through informal discussions with peers, supervisor, and team
- Independently function as a liaison, maintaining timely and frequent communication between company and Sponsor/Client/SD
- Independently ensure scientific integrity of studies
- Independently function as a Principal Investigator, Individual Scientist and/or Study Director
- Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data
- Efficiently perform and document all procedures, materials, and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
- Independently write, review and approve deviations
- Full understanding of regulatory and GXP requirements, industry standards and company SOPs with the ability to mentor others within one operational area
- Independently manage a portfolio of research projects including method development and validation while ensuring timelines are met in a single operational area
- Independently understand the theory and application of correction factors as required by operational area
- Able to recognize method and/or data issues and communicate them to management to minimize study impact independently
- Provide support to staff members as required by operational area as needed
- Lead internal process improvements, presentations and harmonization efforts
- Performs all other related duties as assigned
- Bachelors degree (BA/BS) with 10-12 years of relevant working experience OR Masters degree (MS) with 5-7 years of relevant working experience OR Doctorate degree (PhD) with 2-4 years of relevant working experience
- Must have hands on experience chromatography and LCMS/MS (SciEx equipment preferred)
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
- Ability to communicate verbally and in writing at all levels inside and outside the organization
- Basic familiarity with Microsoft Office Suite
- Computer skills, commensurate with Essential Functions, including the ability to learn a validated system
- 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
- Ability to work under specific time constraints
- P#1
Bioanalytical Chemistry Supervisor - Mattawan, United States - Kelly Science, Engineering, Technology & Telecom
Description
Bioanalytical Chemistry Supervisor
1st Shift
Direct Hire
Compensation: $70k-$80k/yr DOE
Local and relo candidates encouraged to apply
SUMMARY
Bioanalytical Chemistry Supervisor supports the evaluations of test compounds by providing bioanalytical quantitative analysis of drug in body fluids and tissues from non-regulated and regulated studies including preclinical safety evaluations, pharmacokinetic/pharmacodynamic studies, and clinical trials. Staff participate in the development and validation of quantitative LC/MS/MS methodology, sample analysis, and interpretation and reporting of data utilizing validated hardware and software systems. This includes the development of sample extraction techniques, rapid LC separations, and employment of laboratory robotics to enhance delivery time of bioanalytical data. Staff are also knowledgeable in the application of GxPs and applicable SOPs, along with adhering to study protocols to accurately document methods, procedures, and results for inclusion into study reports and regulatory documents.
Company Core Values:
CARE: Respect and support each other; do the right thing; create a positive healthy workplace for
ourselves and our animals; support the communities where we work and live.
LEAD: Model our purpose and values; develop and share our expertise; plan ahead and guide; show
flexibility; embrace change; deliver innovation; appreciate the great work of others.
OWN: Hold ourselves accountable for our actions; respond to internal and external client needs with
speed and accuracy; set and achieve meaningful goals; strive towards continuous improvement.
COLLABORATE: Communicate clearly and effectively; include others; value diverse ideas; help those we serve to succeed; promote teamwork; think broadly and holistically.
RESPONSIBILITIES
QUALIFICATIONS
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