Microbiology Senior Quality Control Associate jobs at Teva in United States, East Bradford Township

• אחסנת משטחים במערך האוטומטי (עבודה על מלגזה)
• מיון, רישום וקבלת סחורה במחשב על פי נהלים
• ליקוט וביקורת הזמנות ללקוח
• פריקת משאיות ומכולות
• עבודה מול מחשב (Word, Excel, Outlook)
• סביבת העבודה בחלקה הינה חדר קור (טמפרטורה של 5 מעלות בממוצע) וחלקה משרדית מול מחשב
• העבודה במשמרות ( בוקר/ערב)

• חריצות, אחריות, אכפתיות, סדר וארגון ויכולת עבודה בצוות
• נכונות לעבודה במשמרות –חובה (תתכן עבודת לילה לפי צורך)
• נכונות לעבודה בשישי / מוצ"ש במידת הצורך
• נכונות לעבודה בש.נ במידת הנדרש
• נכונות לעבודה במאמץ פיזי ממושך - חובה (זאת בכפוף לתקנות הבטיחות בעבודה ובהתאם לנהלי הבטיחות שיוגדרו באתר). לשם כך על העובד להיות בעל כשירות פיזית וללא מגבלות רפואיות רלוונטיות.
• ניסיון קודם בתחום הלוגיסטיקה / מחסן ממוחשב (עבודה בסביבה ממוחשבת ומסופונים) – יתרון! (יתרון לחברות לוגיסטיקה / תרופות)
• אנגלית ברמה בסיסית – חובה
• רישיון נהיגה - חובה
• רישיון מלגזה – יתרון
• בגרות מלאה – יתרון

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 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

• Setting the overarching R&D Innovative Medicines vision and strategy across Immunology & Neuroscience.
• Managing and continuing to evolve the key decision-making forum – Integrated Development Committee (IDC) and associated tools and processes to support robust portfolio decision making.
• Interface internally and collaborate with senior leadership team members across the R&D organization and across Teva.
• Drive the expansion of Teva's portfolios through leadership in partnership with the busines development teams.
• Interface externally with global key opinion leaders around scientific and clinical developments as they relate to drug development.
• Communicate effectively with regulators; guide presentations to Advisory Committees and response to regulatory queries on products submitted for approval including milestone development meetings.
• Develop and articulate Teva’s mission to diverse constituencies such as those at scientific meetings,in targeted peer reviewed publications and other important forums for the Company.
• Coming up with creative ideas around clinical designs to improve timelines and decrease cost.
• Generate the development strategy for compounds manage the execution of the development plan.
• Optimize clinical trials against safety, cost, therapeutic efficacy and endpoint and accelerate the forward movement of pipeline compounds.
• Ensure that all processes related to patient safety in the conduct of clinical trials are strictly adhered to; identify early signals for targeted events/outcomes and propose appropriate responses to such signals.
• Managing matrixed teams, empowering the teams, guiding and giving direction to the teams. In short, the SVP should optimize their way of working.
• Building a best-in-class innovative development organization by identifying, attracting, developing and retaining talent at Teva.

• MD or MD/PhD in a relevant biomedical or life sciences discipline is required.
• Minimum of 15 years of experience in pharmaceutical or biotechnology R&D, with a strong track record in leading innovation-driven initiatives.
• Proven leadership capabilities in managing high-performing, cross-functional teams in a global matrix environment.
• Exceptional strategic thinking, communication, and stakeholder engagement skills.

• A “Doer” with a results orientation. Establishes clear expectations and priorities; drives key initiatives to completion. Sets goals and consistently delivers the plan. Monitors progress and proactively addresses issues and obstacles. Flexible and creative problem-solving skills. Highly decisive and action­ oriented. A strong personal work ethic.
• An enterprising leader and builder. Proven ability to lead key initiatives; motivates teams to work collaboratively to achieve objectives. Achieves organizational focus on key priorities. Provides clear direction, delegates, actively communicates. Superior project and people management skills.
• A nimble strategist. Able to lead/contribute to strategic planning, based on a thorough understanding of industry trends and opportunities. Demonstrated creativity and effectiveness in addressing strategic challenges. Possesses an entrepreneurial mindset; capable of thinking out of the box and taking measured risks.
• A deeply credible scientific reputation. Possesses a solid scientific understanding of products. Understands the importance of strong intellectual property. Able to apply scientific and market knowledge to assess a product’s strategic fit and commercial opportunity. Uses experts effectively.
• Global orientation with strong collaboration skills. A world class team player. Works effectively in a team-based organization, collaborates cross-functionally, exercises influence at senior levels, and builds alignment around goals and objectives. Readily builds consensus and achieves agreement on key initiatives and priorities. Is energized by and effective in working across cultures and time zones.
• Communicator who cultivates followership. Able to inspire team, with strong personal charisma and presence. Ability to simplify and convey complex concepts and strategies, orally and in writing. Effectively conducts/facilitates meetings. Strong presentation skills. Excellent listener; seeks broad input and feedback; frequent and effective follow-up.
• A reputation for unassailable integrity. Possesses unquestioned integrity and strong business ethics. Demonstrates a firm commitment to the company's culture and values. Has the industry reputation and record of achievement to establish trust and credibility with peers, subordinates, collaboration partners, and external constituents.

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.

Executive Vice President, Global R&D & CMO

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 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.

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.

· Develop, optimize, and execute biomarker assays (e.g., ELISA, multiplex immunoassays)

· Perform RT-PCR and qPCR analyses for gene expression studies

· Maintain accurate and organized laboratory records and documentation.

· Analyze experimental data and contribute to technical reports and presentations.

· Demonstrates knowledge of state-of-the-art principles and techniques

· Ensure compliance with laboratory safety and quality standards

Minimum Qualifications

· B.S. degree in Biology, Biochemistry, Molecular Biology, or related science with a minimum of 5 years of experience, or M.S. degree with a minimum of 3 years of experience in the biotech/biopharma or CRO industry.

· Experience in biomarker assay method development, qualification/validation and sample analysis in support of preclinical or clinical studies

· Strong attention to detail, organizational skills, and ability to work independently

· Solid understanding of regulatory bioanalysis guidelines and relevant clinical practices

· Effective communication and teamwork skills

Preferred Qualifications

· At least 5 years of experience in biotech/biopharma or CRO

· In-depth knowledge of ligand binding assays and other bioanalytical methodologies

· Experience with NanoString Technology is a plus

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
• The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent 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.