Cmc Biologics Quality Control Director Physichemical Testing jobs at Teva in United States, East Bradford Township

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.

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

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.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Important notice to Employment Agencies - Please Read Carefully

The Associate Director of Transparency and Disclosure (T&D) is responsible for leading and managing global Transparency & Disclosure activities. This role will serve as a subject matter expert and will manage the processes and procedures to ensure compliance with global regulatory requirements. The Associate Director will partner with and lead interactions with senior management in relevant functional areas and manage staff who are directly involved in activities related to disclosure and transparency. Oversight of staff who manage clinical trial registry activities, lay language results summaries, and data sharing requests will also be in scope.

• Ensures compliance with US/EU requirements for clinical data transparency and disclosure, including EMA Policy 0070, EMA Policy 0043 and Health Canada.
• Ensure development of plain language results summaries.
• Manages and oversees vendor/CRO involvement for registrations, results postings, and plain language summaries to assure data harmonization.
• Oversees facilitation of registration and results postings in Teva’s clinical trial disclosure platform for global data harmonization management.
• Oversee internal systems experts, including but not limited to disclosure and document management databases.
• Assures quality and accuracy with clinical trial information in public registries.
• Facilitates review and assessment of data sharing requests from external researchers.
• Ensures maintenance of transparency, including routine updates of active registrations and updates to results disclosures.
• Establishes and maintains close working relationships with project teams, as well as with other internal stakeholders.
• Works cross-functionally to continuously improve processes and facilitates SOP updates.
• Internal advocate for Teva’s disclosure standards, policy, and public accessibility to data.

• PhD/PharmD with a minimum 6 years experience or a Master’s with a mnimum of 8 years experience
• Advanced degree in Life Sciences, Pharmacy, or Medicine.
• A minimum of 6 years of experience in Transparency and Disclosure

Experience Preferred:

• 6-8 years of experience in Transparency and Disclosure preferred.
• A broad understanding of the legal/regulatory requirements and guidelines with regard to clinical trial transparency and disclosure.
• Working knowledge of clinicaltrials.gov, clinicaltrialsregister.eu/CTIS databases, Policy 0070
• An understanding of the clinical drug development process, including clinical trial design, operations, and results analysis. Relevant experience in Regulatory Affairs.

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.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

The Associate Director, Real-World Evidence (RWE) Statistics sits within Global Statistics & Data Science (GSD) and partners with cross-functional teams in Teva R&D to provide statistical strategy and technical leadership for analysis of Real-World Data (RWD) and other data sources to support lifecycle drug development. The key responsibilities include statistical input to the evidence generation planning, medical affairs and RWE research proposal reviews, study protocol and statistical analysis plan (SAP) development and execution, results interpretation, scientific presentations and publications, interactions with agencies, and RWE/statistical methodology research. In this role, your expertise will elevate data generation, inform decision-making, and ultimately improve patient outcomes.

• Lead RWE statistical input for evidence generation planning for assigned TAs/assets, collaborating closely with global and regional Medical Affairs, Health Economics, Value and Outcomes, and other R&D stakeholders.
• Actively engage in the development and review of study concepts and protocols, ensuring alignment with objectives, and appropriate sample size and statistical methods for scientific, regulatory, and market access needs.
• Lead or oversee SAP development and execution, including table, figure, and listing shells, and output review. Collaborate with programmers/analysts to ensure timely, high-quality statistical deliverables. Develop data review plans, interpret complex data, and ensure study results are scientifically robust and actionable.
• Provide in-depth statistical review for scientific publications and reports. Work closely with internal and external stakeholders to ensure appropriate statistical analysis and results are consistently applied in all scientific and regulatory documents, presentations, and publications.
• Contribute to external interactions with regulators, payers, and other agencies.
• Demonstrate excellent understanding of advanced statistical concepts. Take a leadership role in introducing innovative statistical methods (e.g., causal inference, bias and confounding control, AI/ML) into analysis plans to improve efficiency and validity of study results. Effectively explain statistical concepts to non-statisticians.

• PhD (with 4+ years of experience) or MS (with 6+ years of experience) in Biostatistics, Statistics, or a related quantitative field.
• Pharmaceutical or related industry experience required.
• Competence in RWE study design, statistical modeling, and AI/ML methods to observational data. Knowledge of methodologies for confounding control and bias minimization in observational studies highly desired.
• Expertise with multiple RWD sources (e.g., EHR, claims, registry data); familiarity with clinical trial design.
• Proficiency in programming skills in SAS, R, and/or Python; experience with cloud-based analytics platforms is a plus.
• Ability to build strong relationships with cross-functional partners to provide cutting-edge statistical solutions, drive data-driven innovation, and achieve high performance.
• Highly motivated to learn new methodologies and technologies, open-minded and adaptable, enthusiastic about innovation and making meaningful impact.
• Excellent writing and communication skills.
• Demonstrated leadership and project management abilities.
• Experience supporting HTA submissions, or regulatory interactions is preferred.
• Track record of publications or presentations in RWE methods is preferred.
• Familiarity with clinical trial data standards (ADaM/SDTM) and data privacy regulations is preferred.

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.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

The Director, Statistical programming TA Head, provides strategic and technical leadership for programming deliverables within a therapeutic area. This role is accountable for high-quality and efficient delivery of statistical programming deliverables within a therapeutic area. As a leader, the Director defines delivery strategies, anticipates and mitigates risks, fosters innovation in programming technologies and processes, forecasts and maintains budget. This position will be a key partner to Therapy Area Head, Statistics and ensures successful implementation of statistical programming strategies and efficient execution of programming deliverables within the therapeutic area. The role also includes functional management responsibilities such as talent development, recruitment, and coaching, ensuring a skilled and motivated global programming team.

• Provide strategic leadership for programming deliverables across a disease area, or therapeutic area.
• Define and implement programming strategies that enable high-quality, efficient, and compliant outputs for regulatory submissions and clinical trial reporting.
• Lead and develop global programming teams, including direct reports, contingent staff, and vendors
• Partner with cross-functional stakeholders (Statistics, Data Management, Clinical Development, Regulatory) to ensure alignment and successful execution of programming deliverables, Sets tasks and prioritization within a disease area, or therapeutic area.
• Delivers comprehensive programming leadership to clinical project teams and vendors, driving the implementation of standards, specifications, and analyses in compliance with regulatory expectations, SOPs, and organizational practices.
• Drives innovation and continuous improvement projects within programming, challenges status-quo, implements innovative strategies and technologies for clinical trial programming within the therapeutic area.
• Contributes to other department initiatives.
• Provide training, mentorship, and coaching to build a high-performing programming workforce.
• Drives the recruitment and retention strategies for Statistical Programming within a TA, in collaboration with Statistical Programming LT, HR and Talent Acquisition teams
• Manage budgets, forecasts, and resource allocations effectively to meet organizational priorities within a TA.
• Ensures that SOPs and guidelines are followed, and the clinical programming processes are well known by all teams within the TA.
• Keep abreast of industry programming and technological advancements.
• Member of Statistical Programming Leadership Team, and member of Extended GSD Leadership team, in shaping up the function and department vision.

• Bachelor’s Degree/Master’s Degree/PhD in Science, Statistics, Information Technology or equivalent combination of education and related work experience is required.
• A minimum of 10 years of experience in a pharmaceutical or clinical research setting as a programmer.
• Expert knowledge of the drug development process, clinical trial methodology, regulatory requirements, industry standards, statistical principles, and medical terminology relevant to data analysis and submission.
• Proven ability to attract, develop, and retain top talent.
• Proven ability to influence clinical programming processes.
• Demonstrated success in leading business process transformations, driving organizational culture change, and advancing programming expertise on complex programs.
• Directed programming teams through numerous successful submissions and approvals in key global markets.
• Serves as the subject matter expert in all aspects of Clinical Programming. Initiates and leads multi-disciplinary pivotal projects to improve operational processes related to Clinical Trials execution and Data Presentation. Provides development plan for efficiency of programming processes and systems.
• Active member of professional industry organizations and contributor/presenter at scientific Congresses/Conferences.
• Formulates strategy under guided supervision; Demonstrates ability to both differentiate and determine optimal strategies.
• Tackles complex problems; Makes independent decisions using analysis to drive solutions.
• Persuade and inspire team to take action; Expert negotiation skills; lead process development and improvement cross-functionally.

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.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Associate Director, Data Visualization & Analytics Project Lead will provide strategic leadership and technical expertise to drive the development, implementation, and enhancement of advanced data visualization tools and dashboards and exploratory analytics to provide insights into our clinical trial data and to support decision-making across clinical development programs. This role sits within GSD (Global Statistical & Data Sciences) organization. This position is primarily responsible to define and execute the data visualization strategy, driving cross-functional alignment with R&D functions, Clinical Teams, Statisticians and Statistical Programming to deliver visualization solutions as well as exploratory analytics that meet scientific and statistical needs.

Role requires frequent interactions with Leadership and Cross-functional management to influence key decisions and drive the Data Visualization projects.

Strategic Leadership

• Drive the GSD data visualization and exploratory analytics strategy, aligning tools and capabilities with business priorities and emerging technology trends, with the goal to enhance understanding of the trial data and gain insights into and trends.
• Engage with senior leadership and cross-functional management to set goals, prioritize projects, and influence technology adoption.
• Champion best practices in data visualization, user experience (UX), and effective data storytelling.
• Proactively assess internal and external data visualization trends to maximize business value.
• Oversee contingent workers and / or vendors, Strategically analyze needs to manage resources and provides input for Budget Planning

Solution Development & Technical Expertise

• Lead the design and delivery of scalable, user-friendly interactive visualization solutions for clinical data exploration (Safety, Efficacy and other clinical trial data) across various clinical development programs.
• Manages and delivers assignments with quality and within timelines
• Stay current with industry trends and emerging tools/technologies in the data visualization and analytics space.

Stakeholder Partnership & Change Management

• Partner with clinical scientists, clinical physicians, statisticians and programmers to gather requirements and translate them into visualization deliverables.
• Develop and deliver training to team members and business partners on visualization tools, capabilities, and methodologies.
• Lead cross-functional, matrixed project teams to support system enhancements, new tool rollouts, and user adoption strategies and oversee change request governance.

Governance & Compliance

• Ensure data integrity, and business risk assessment for visualization systems and underlying data.
• Ensure visualization solutions meet data privacy requirements.
• Ensures that SOPs and guidelines are followed.

• Bachelors/Masters Statistics, Biostatistics, Computer Science, Information Technology or equivalent combination of education and related work experience is required.
• A minimum of 8 years of professional experience in a pharmaceutical or clinical research setting as a programmer including supporting regulatory submissions is required.
• Hands-on expertise with R (Shiny, ggplot2), Python, Tableau/Spotfire and SAS is required.
• Strong understanding of Clinical Trail data standards CDISC (SDTM, ADaM).
• Understanding of common clinical trial statistical methodologies.
• Proven track record in leading cross-functional teams and influencing at leadership levels.
• Excellent communication skills, with the ability to translate complex analytical concepts into clear compelling visual narratives.

The annual starting salary for this position is between $163,000 – 214,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

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.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

The Associate Director, Alliance/Vendor Relationship Manager will be responsible for managing and optimizing relationships with external vendors supporting Global Clinical Operations efforts of the organization. This role is essential in ensuring that clinical vendors deliver high-quality services on time and within budget while adhering to regulatory requirements and organizational standards.

Strategic Vendor Management:

• Develop and implement vendor management strategies and tactics, including leadership of and direct support of governance and performance related documents, charters, and tracking/reporting mechanisms for clinical trial vendors as assigned.
• Establish and monitor Key Performance Indicators (KPIs), Operational Key Metrics (OKMs), and Key Risk Indicators to ensure vendor performance aligns with project and corporate objectives.
• Cultivate strong, collaborative relationships with vendors to ensure service quality, efficiency, and alignment with the organization’s goals.

Performance Oversight and Governance:

• Oversee the performance of key vendors in partnership with functional stakeholders, ensuring they provide high-quality, timely, and cost-effective services for clinical trials.
• Lead regular governance forums, such as Joint Operating Committees to review vendor performance, address issues, and drive continuous improvement.
• Act as the internal primary escalation point for vendor performance issues, collaborating with providers and stakeholders to develop and execute risk mitigation strategies.

Financial and Contract Management:

• In partnership with internal stakeholders and functions, monitor vendor budgets, forecast expenditures, and report on spending to identify opportunities for cost savings and efficiency improvements.

Compliance and Quality Assurance:

• Ensure that all vendors comply with regulatory requirements (e.g., ICH GCP), industry standards, and company policies.
• Coordinate with Quality Assurance to conduct regular audits and assessments of vendor processes, addressing compliance issues as needed.
• Lead periodic reviews and benchmarking exercises to ensure that vendor performance meets or exceeds industry standards for cost, speed, and quality.

Continuous Improvement and Innovation:

• Drive initiatives to improve vendor management processes, including the adoption of new technologies and best practices.
• Foster a culture of continuous improvement by encouraging cross-functional collaboration and sharing of best practices to enhance overall clinical trial operations.

The person hired for this role will need to work in a hybrid environment out of our West Chester, PA office

• Bachelor’s degree in Life Sciences, Business, or a related field. An advanced degree (e.g., MBA, MS in Clinical Research) is preferred.

• Minimum of 10 years of experience in the pharmaceutical or biotechnology industry, with at least 5 years in vendor management or a related role in clinical research.
• Demonstrated experience in managing complex Alliance/Vendor Relationships and leading governance activities within a matrix environment.
• Strong knowledge of clinical research and development processes, including regulatory requirements (ICH GCP) and clinical trial operations.

• Excellent communication and interpersonal skills, with the ability to build and maintain relationships with internal and external stakeholders.
• Strong analytical and problem-solving skills, with a focus on optimizing vendor performance and ensuring cost-efficiency.
• Ability to work independently and collaboratively in a fast-paced, dynamic environment.

The annual starting salary for this position is between $139,120– 182,595 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

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 holiday.
• 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.
The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

Senior Director, Alliance Management

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.