Bioanalytical Method Development Scientist, Director
Location: Austin, Texas, United States
Requisition Number: 1130
Position Title: Director, Method Development and Validation
SUMMARY: Oversee and direct the methods development and validation teams at Worldwide. The Director will lead operational laboratory planning to ensure deliverables are met on awarded work. The individual will be responsible for maintaining a culture of employee engagement and accountability in support of scientific business deliverables and ensure timely completion of method development and validations in support of non-clinical and clinical study sample analysis.
Tasks may include but are not limited to:
- Responsible for strategic scientific decisions affecting assay development and validation with strong
- Work closely with Worldwide Staff to provide expertise in the area of assay development utilizing new technologies and automation and supporting innovative solutions for developing and validating assays.
- Actively develop reports through strong oversight, training, coaching, and mentoring in scientific, technical, and regulatory areas. Responsible for growing the technical staff within the lab.
- Review analytical test methods (ATMs) for accuracy, provide responses to regulatory audits and SOP’s or other guidelines. Ensure timely release of such reports and information.
- involvement in troubleshooting in these areas in support of timely deliverables.
- Monitor and Manage method development and validation timelines for projects.
- Develop strong working relationships with key stakeholders to develop timelines for deliverables.
- Excellent communication skills to effectively relay project status including challenges to Sponsors.
- Interacts with reports, peers, and key stakeholders effectively and communicates ideas clearly.
- Responsible for actively promoting technical development programs, to keep Worldwide at the forefront of technology.
- Maintains state-of-the-art knowledge pertaining to bioanalytical methodologies.
- Promotes Worldwide’s scientific capabilities through publications, attendance at conferences, lectures, and/or seminars.
- Monitor the performance of the employees in his/her group on an ongoing basis and make appropriate communications regarding performance to employee, management and human resources
- Ensure staff compliance with required training of departmental GLP, SOP, safety, and other guidelines.
OTHER SKILLS AND ABILITIES:
- Expert knowledge of bioanalytical methodology used in the pharmaceutical and biotechnology industries. with a focus on small molecules, peptides, and oligos utilizing LC-MS/MS and other large molecule analytical platforms.
- Strong knowledge of drug discovery, drug metabolism, pharmacokinetics, and toxicokinetic as applicable to bioanalytical activities.
- Working Experience supporting mass balance studies including metabolite profiling.
- Established record of publications and oral presentations at national scientific meetings.
- Strong organizational and problem-solving skills and the ability to set priorities.
- Strong computer skills, including laboratory data acquisition technology.
- PhD, or postgraduate degree preferred. Bachelor’s Degree in Chemistry, Analytical Chemistry or scientific discipline equivalent
- Scientific management level experience required
- 12 or more years managing methods development in support of regulated bioanalysis with expert knowledge of scientific principles and concepts
- Business knowledge as it relates to efficiency of processes and timely deliverables
- Proven track record in the execution of the company’s business objectives, and laboratory operations success and growth in the area of bioanalytical methods development and validations.
Employment Type: Regular
Community / Marketing Title: Bioanalytical Method Development Scientist, Director
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Austin, Texas US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.