Associate Director Large Molecule Bioanalytical Assay Development
The Associate Director will apply their experience in method development and validation, as well as
experience in sample analysis, to lead a team of high-level scientists to support multiple projects across
several clients. The Associate Director will be responsible for a budget unique to each engagement and
will allocate and manage team resources to achieve both internal and external goals and objectives
within the allotted budget. The Associate Director will be the principal partner and contact point with
each client to ensure expectations are appropriately managed and communicated. The Associate
Director will create an uplifting environment within their team, balanced within a culture of
accountability. The leader will develop and support each member of their team to grow professionally
and increase their contribution to the company and their customers.
The Associate Director’s success will principally be measured by their ability to optimize the team’s
performance within budget parameters and to maintain and grow customer relationships. The
Associate Director will also be measured by their ability to scale their team while continually optimizing
productivity, revenue, and quality. The Associate Director’s ability to adapt their communication style to
a diverse array of audiences, and to diplomatically spin negative circumstances into positive outcomes,
will be a significant contributor to the individual’s success.
Essential Duties & Responsibilities:
• Oversee team to ensure projects or completed on time and within budget.
• Ensure the scientists in the lab are optimally productive and efficient, and their challenges are
overcome.
• Communicate regularly and diplomatically with internal stakeholders and functional leaders.
• Continually communicating with primary sponsor contacts to ensure internal business needs
and needs of customers are being met.
• Schedule resources to ensure coverage, then escalate up to management as needed if
additional resources become necessary.
• Establish and demonstrate a clear knowledge of personnel, equipment, and capabilities.
• Maintain an open, non-hierarchical and team-oriented environment. Delegate as needed yet
will do whatever is necessary to ensure all work gets done.
• Provide direction and oversight to a team of high-performing scientists. Provide support as
needed to ensure the team develops and can overcome challenges.
• Participate in revenue forecasting activities.
• Coordinate with leadership to define and implement strategies to maximize profitability and
capacity utilization.
• Coordinate with Business Development to ensure they understand internal processes and
capabilities.
• Serve as liaison between scientific and operations teams and customers to assure accurate
communication of information, requirements, and expectations.
• Provide client services support and operations to guarantee client satisfaction and ongoing
revenue.
• Support new business development efforts as a subject matter expert and customer liaison.
• Share best practices with the team to ensure overall team success.
• Domestic travel as required.
• Perform other duties as assigned.
• Attend trade shows and exhibitions as requested.
QUALIFICATIONS
• A Ph.D. in life or physical science discipline (biochemistry, chemistry, biology) is preferred,
however, commensurate related experience will be considered.
• At least 5 years’ experience with assay method development and validation, preferably cell-based,
supporting the development of biologics and vaccines.
• Experience within a CRO leading project teams, either directly or within a matrixed structure,
providing services to support the development of biologics and vaccines.
• Familiarity with assay applications including Pharmacokinetic (PK), Toxicokinetic (TK),
Pharmacodynamic (PD), Biomarkers, Bioassays (NAB), Immunogenicity.
• Demonstrated supervisory and project management experience, including technical and
regulatory oversight of client’s studies.
• Experience overseeing the development and validation of clinical and biomarker assays.
• History of conducting and overseeing the analysis of clinical and nonclinical samples for all
therapeutic programs in a GLP laboratory.
• Experience training and developing advanced scientific personnel.
• Experience with a LIMS system, preferably Watson LIMS.
• Experience overseeing method transfer is a plus.
• Accustomed to working in a fast-paced, dynamic environment.
• Ability to work collaboratively with stakeholders to resolve issues.
• Strong focus on customer service, quality, and accuracy.
• Adept at articulating effective responses to the most sensitive inquiries or concerns from
customers, regulatory agencies or members of the business community.
• Open, interactive communication style; strong interpersonal skills coupled with a service
mentality.
• Excellent written and verbal communication and presentation skills.
• Strong analytical, organizational and time management skills.
• An adaptable and dynamic communication style that radiates honesty, integrity, and credibility and
is coupled with astute listening skills.
• Solutions oriented personality that embraces challenges as opportunities and demonstrates a
dogged drive to take initiative and diplomatically resolve issues or challenges.
• Collaborative nature compels the individual to work with teammates and always help others to
optimize performance.