Director, PK Bioanalytics

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Our Team, Your Impact

Job Summary: Teva Pharmaceuticals in West Chester, PA is looking for a self-motivated Director to oversee bioanalytical strategy, laboratory operations, and regulatory compliance for Teva Innovative Biologics development and research. This position will manage assay development, validation, and sample analysis to support preclinical and clinical pharmacokinetics studies of Teva biologics drug development pipelines. This role requires expertise in bioanalytical techniques such as but not limited to ligand binding assays. Additionally, they ensure compliance with GLP/GCP guidelines and collaborate with cross-functional teams to drive scientific decision-making. 
This dynamic role combines hands-on scientific oversight with high-level team leadership and cross-functional collaboration. These abilities are vital to overseeing complex studies, ensuring data integrity, and leading a team in a high-stakes environment. 

 

Job responsibilities
•    Lead a team of 10-15 people, setting and monitoring goals, addressing performance challenges, and overseeing hiring and onboarding of new employees.
•    Develop strategies for PK methods for complex biologics such as bispecific, fusion molecules to ensure fit for purpose.
•    Represent the PK group and work collaboratively with Critical Regent, Non-Clinical, Clinical Pharmacology, Clinical Pharmacometrics, Biomarker and Immunogenicity Assessment groups to ensure strategies are aligned.
•    Ensure compliance with global regulatory standards (ICH, GCP, GLP), contribute to regulatory filings (IND, BLA, MAA) and interact with Regulatory Agencies during face-to-face meetings, teleconference, or on-site inspections.
•    Serve as a Single Point of Contact for specific projects in Non-Clinical and Clinical development meetings.
•    Identify and propose improvements to enhance robustness, quality, and efficiency, by working closely with Lab Operations, Compliance and Quality and Automation and Quality Assurance groups.
•    Ensure timely and high-quality data delivery within allocated budget.

Your Skills and Experience

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. 

 

Education/Certification/Experience:

•    The candidate must have a Master’s Degree in Biochemistry, Pharmacology or related field with a minimum of 15 years of relevant experience or PhD with a minimum of 12 years of relevant experience in biopharmaceutical industry, with a minimum of 5 years in leading a group of 10+ bioanalytical scientists.

 

Skills/Knowledge/Abilities:
•    The candidate must have proven experience in organizational growth, change leadership, and directing high-functioning team in a bioanalytical science area.
•    Familiarity with laboratory information management systems (LIMS), and relevant regulatory guidelines (FDA, EMA) is essential.
•    Strong leadership, project management, problem-solving, effective communication and presentation skills are required.
•    Familiarity with system validation, automation (AI/ML) is a plus.

 

TRAVEL REQUIREMENTS

Some occasional domestic and international travel may be required if business needs arise.

How We’ll Take Care of You

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. 
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. 
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays. 
• Life and Disability Protection: Company paid Life and Disability insurance. 
• 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, Vo