Teva Associate Director Binding Cell-Based Bioassay - Onsite West Chester PA 

United States, Pennsylvania, East Bradford Township 

80336255

The Associate Director at Bioassay Department of Biologics CMC leads a team of professionals to develop and execute plans on binding and cell-based bioassay development, qualification, and validation to support both the clinical and commercial stage programs. This important leadership role will function as an expert to provide technical guidance to scientists to design, troubleshoot, and transfer various assays. This role requires close collaboration with cross-functional teams to support regulatory submissions. This role reports to the head (Senior Director) of Bioassay Department.

• Lead and oversee development, qualification, and validation activities for binding (ELISA, homogeneous), cell-based, flow cytometry, and other functional assays.
• Provide guidance to design, develop, optimize, qualify, validate, and transfer potency methods to support the release and characterization of biologics in conformance with cGxPs.
• Lead and support characterization and comparability studies; support establishment of control strategy for early and late-stage programs.
• Partner with the stakeholders and SMEs to align on priorities, resources, support, and expertise as required.
• Work with bioassay team management and develop talents; promote team work orientated initiatives and operational excellence.

• Ph.D. in Biological Sciences, Cell Biology, Molecular Biology, or related field and a minimum of 7 years of related working experience, OR Master's degree in a scientific field of study with a minimum of 10 years of relevant working experience.
• Minimum 2 years of management experience, including the management of staff and activities within a matrix environment.
• Ability to effectively manage a portfolio of projects, multi-task in a highly dynamic environment, and influence cross-functional teams in a professional and positive manner.
• Deep working knowledge of regulatory guidance and quality standards; experience authoring and reviewing regulatory submissions and responses as well as other interactions with Health Authorities.
• Excellent verbal and written communications skills, and an ability to excel in a team-based environment.

We offer a competitive benefits package, including:

· Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

· Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

· Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

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