CMC Biologics Quality Control Director, Physichemical Testing

CMC Biologics Quality Control Director, Physichemical Testing

Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.

The Physiochemical Testing group strives to deliver creative medicines to patients through performance fundamental chemical, physical and structural testing within a GxP-compliant QC laboratory to support preclinical and clinical production as well as commercial launch. Primary responsibilities center on being able to develop, implement and manage departmental strategies for physiochemical testing with respect to product in-process, release and stability testing, raw materials testing, contract lab testing, and regulatory submissions. The incumbent may also participate in / provide oversight of activities related to the management of CGMP analytical method lifecycle (e.g. management of reference standard, assay control, critical reagents and materials, product specification and sampling plan processes). The incumbent should possess a practical understanding of bio-pharmaceutical drug development and GxP requirements as knowledge of local, regional and global regulatory compliance (ICH, GMP, EPA, OSHA, DEA, etc.) are integral responsibilities of this position.

Overseeing QC laboratory operations by managing a team of professionals and junior managers who execute physiochemical CGMP testing. Establishing and maintaining strategies for method and / or process implementation, continuous improvement initiatives, and method transfer and validation processes. Developing strategies and approaches for special studies, as applicable. Ensuring compliance with applicable ICH, GxP and safety regulations as an individual contributor as well as an educator and manager of junior staff. Executional tasks include but are not limited to : supporting general GxP and data integrity compliance in both routine and non-routine work activities for both internal and external contract lab testing. This includes efforts as an individual contributor that may include but are not limited to the review and approval of data in raw and reported forms as well as training staff in compliance or technical principles; providing oversight and / or support of QC lab investigations, audits, inspections, and communications with regulatory agencies and health authorities; providing support for staff who identify, write, revise, manage and implement standard operating procedures, work instructions, standard practices, protocols, and reports. Executing these tasks as an individual contributor, as applicable; engaging, coaching, motivating and empowering staff to ensure their skills match their roles and to continually develop, thereby improving productivity and efficiency of the department operations. Participating in critical business processes, including but not limited to capital equipment procurement, workforce planning.

Education Minimum : BS / MS in relevant discipline Preferred : PhD in Biochemistry, Analytical Chemistry. Experience 10-15+ years (BS / MS / PhD) in the (Bio)pharmaceutical industry with deep technical knowledge in physiochemical testing applications and one or more areas of drug development. Champion the creation and maintenance of a productive multidisciplinary team while working effectively with team members and management. Represent QC as a leader who effectively guides matrixed and cross functional teams to successfully deliver business results. Administer and / or coordinate all aspects of the project / program's physiochemical testing activities. Utilize expertise and leadership skills to direct staff and to resolve issues to ensure project goals are met. Drive an innovative / creative culture in delivering business results. Account for the performance and results of the physiochemical functional area as well as support the performance and quality of results for the QC department. Understand and lead others through the interdependencies of various functions within the CMC organization. Design, plan, organize, analyze, and evaluate key elements of Biologics CMC QC strategy. Specialized Knowledge : LIMS, TrackWise or VEEVA Quality Management Systems, Documentum Based Systems.

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, Voluntary Life Insurance and Long Term Disability and more.

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.