Process Development

Associate Director, Analytical Assay Development Direct Hire MA

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Job ID: 15557 Direct Hire MA

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Job Description:

Our client is a very well-funded biotech company at the forefront of developing the next wave of innovative biologics to treat patients. They are looking for an Associate Director/Director of Analytical Assay Development with relevant industry experience to join their growing team and build out this function! This is a full-time, permanent career opportunity and will work cross-functionally with scientists in the lab as well as quality and manufacturing teams for technology transfers under cGMP. Ideal candidates will leverage their industry and CMC regulatory knowledge for biological product development in various stages and apply Quality-by-Design (QbD) initiatives.

Responsibilities:

• Design and lead a small team in analytical development by working with upper management to implement new projects and oversee data tracking and trending

• Work cross-functionally with scientists to oversee assay qualification and standard operating procedures (SOPs)

• Develop non-traditional analytical methods for biologic product characterization, development, and release criteria

• Implement creative problem-solving skills to innovate solutions in a rapidly evolving company and participate in strategic and budgetary meetings to ensure goals are met

Requirements:

• Ph.D. in Life Sciences, Microbiology, Chemistry, or related field

• 6-10+ years of relevant industry experience in drug development

• qPCR and flow cytometry experience for analytical development of complex biologics or vaccines

• Previous experience with developing analytical methods and proven track record of leadership

• Keen ability to plan experiments, analyze complex data sets, troubleshoot experiments, and present results and reports to senior management

Perks/Benefits:

• Medical, dental, vision, short-term, and long-term disability

• 401(k) plan with generous contribution

• 15 vacation days, flexible PTO, paid parenteral leave

• Join a truly passionate, motivated team to deliver on their mission of helping patients

• Free weekly lunches, discounted ride-sharing to the office, subsidized gym, and more!!

Candidates must be authorized to work in the US indefinitely to be considered. All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients. Formal descriptions can be supplied for interested candidates.