Associate Director, Method Development

Requisition Number: 1130

Position Title: Associate Director, Method Development

External Description:

SUMMARY: Oversee and direct the methods development team at Worldwide.  The Associate Director will lead and provide strong scientific focus on various method development and 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 in support of successful validation and ensure methods are robust to support non-clinical and clinical study sample analysis (successful ISRs). 

RESPONSIBILITIES:

Tasks may include but are not limited to:

• 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 
• 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 

• Embrace actively and diligently learn the genotyping project and plasma protein binding technologies at Worldwide in support of continued success 
• Responsible for strategic scientific decisions affecting assay development and validation with strong involvement in troubleshooting in these areas in support of timely deliverables 
• Monitor and Manage method development timelines and appropriate communications for projects 
• Develop strong working relationships with key stakeholders to develop timelines and associated metrics 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 
• 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 
• 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 the employee, management, and human resources 
• Ensure staff compliance with required training of departmental GLP, SOP, safety, and other guidelines 
• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. 

OTHER SKILL AND ABILITIES:

• Expert knowledge of bioanalytical methodology used in the pharmaceutical and biotechnology industries. with a focus on small molecules, peptides, and oligonucleotides utilizing LC-MS/MS 
• Experience in mass balance, metabolism, metabolite profiling, and high-resolution mass spectrometry highly desirable 
• Knowledge in other large molecule analytical platforms (MSD, Luminex, Quanterix, etc is desirable 
• Strong knowledge of drug discovery, drug metabolism, pharmacokinetics, and toxicokinetics as applicable to bioanalytical activities 
• 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 
• Focus on cross-training and embracing teamwork, strong team culture, and continuous

 REQUIREMENTS:

• Ph.D. Degree in Chemistry, Analytical Chemistry or equivalent scientific discipline 

• Scientific management level experience required 
• 8+ 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, timely deliverables and metrics in a Life 

 

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City:

State: Texas

Employment Type: Regular

Community / Marketing Title: Associate Director, Method Development

Company Profile:

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 is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.