דרושים Senior Analytical Scientist ב-טבע ב-אירלנד

We would like to invite applications for the role of an permanent Lead Product Development Scientist position at our Waterford Site.

Key Responsibilities

• Leading the development and manufacture of inhaled drug delivery systems, including dry powder inhalers and pressurised metered-dose inhalers (pMDIs).
• Inputting into manufacturing processes strategies from concept through scale up to commercialisation.
• Design and develop novel formulations for inhaled drug delivery systems, including dry powder inhalers and pressurised metered-dose inhalers (pMDIs).
• Responsible for identifying Critical Process Parameters (CPPs) through Design of Experiments studies and developing robust manufacturing processes using Quality by Design (QbD) and Quality Risk Management (QRM) principles.
• Developing professional relationship with TGO and lead process technical transfers to commercial partners including pre-submission process validations manufacturing if required.
• Preparing and review documentation for regulatory submissions (IND, NDA, ANDA, etc.)
• Working as an integral member of a larger team alongside Formulation
• Pre-formulation and reverse engineering of products identifying Critical Material Attributes (CMAs) and Critical Quality Attributes (CQAs).
• Use contemporary Design of Experiments (DoE), data analysis and risk management techniques to assess development strategies and prioritize activities.
• Work as part of a team who will be responsible for overall product development of novel respiratory therapies from concept through to clinical trials and commercialisation.
• Identification of innovative opportunities to support process and formulation optimisation approaches.

Are you….

• Bachelors, Masters or PhD qualified in physical sciences, chemical engineering (or related subjects)
• Bringing industry experience within a Pharmaceutical R&D based Scientist role
• Experienced in process development, drug product manufacturing and process scale-up is essential

Do you have….

• Experience in DoE design, data modelling and risk management would be beneficial
• The ability to work as a flexible member of a project team, be quality orientated, be aware and work to tight deadlines
• Adaptable personality-able to work with changing priorities and the flexibility to re-prioritise work schedule
• Excellent verbal and written communication, organisational skills and computer skills

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.

Teva designs eligibility to empower and enable employees to manage their careers internally and provides an easy and smooth process to view and apply. To be considered for an open internally posted position, an employee must:

• Be a current employee of Teva
• Meet the basic requirements for the job
• Have received a rating not lower than “Successful” on their most recent performance review and must not currently be on a performance improvement plan
• Apply to the posted requisition within the allotted time frame
• Have been in their current position for a minimum tenure of twelve (12) months

Unless explicitly stated in the job description, no company sponsored work authorisation or relocation assistance should be assumed.

We would like to invite applications for the role of an permanent Analytical Researcher position at our Waterford Site.

Key Responsibilities:

• Heavily involved, or occasion leading, scientific/technical investigations and develop approaches to solve wide ranging, difficult and complex problems.
• Working closely with product development teams and/or processes, characterisation, investigations and root cause analyses.
• Compilation and review of detailed technical documents.
• Ensuring that work is carried out in compliance with the required standards conforming to company, cGMP, GLP, SOP, regulatory, H&S and environmental requirements.
• Working cross-functionally with significant communication channels between departments such as Manufacturing, QC, QA, Regulatory Affairs and Operations to address deficiencies, fillings of new regulatory applications etc.
• Contributing to production of Module 3 regulatory submissions and associated correspondence with regulatory agencies.
• Delivering excellent customer service (both internal & external) through project timelines in accordance with company procedures & regulatory guidelines.

Do You Have:

• Career experience within a Pharmaceutical laboratory setting.
• Experience working to current Good Manufacturing Practice and/or Good Laboratory Practice and implementing policies and procedures in line with regulatory guidelines.
• Knowledge of global regulatory and compliance requirements.
• Excellent planning and organising skills & adaptable to changing priorities.

Are You:

• Bringing a breadth of data analysis skills.
• A confident communicator both verbally and in writing.
• Valuing colleague collaboration and team building.

Jamie Fitzpatrick

Senior Supervisor, Analytical R&D

The Senior Biosimilar Regional Account Manager is responsible for recruiting, coaching, managing and training Biosimilar regional Account managers (BRAMs).

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• The Senior Regional Manager leads a team of BRAMs that are responsible for creating successful partnerships between Teva and identified customers to promote Teva's product portfolio of biosimilar products
• Responsible for contributing to the achievement of TEVA’s overall annual business objectives
• Clarifies and sets team objectives/expectations, formulates and executes a strategy to ensure performance targets are met/exceeded.
• Provides guidance/coaching in the creation and development of account plans, execution of plans through effective coordination, collaboration and communication. Monitors account plans to ensure objectives and performance targets are achieved.
• Coaches BRAMs on understanding external environmental forces, and emerging trends that affect the healthcare, biotechnology industries and Teva’s markets, products, and operations.
• Models behavior that encourages honest, timely, and specific feedback and establishes expectations for others to do the same.
• Provides frequent individual coaching and feedback that empowers the BRAM’s ability to achieve objectives. Utilizes the following tools but not limited to: monthly business plans, annual and semi-annual performance reviews
• Develops and helps Direct Reports achieve their Individual Development Plans
• Recruit, interview, hire, develop and retain top talent.
• Partners and works cross-departmentally with Sales, Marketing, Market Access, National Account Directors, and Regional Account Managers to insure customers are served appropriately, uncovers opportunities for new sales growth, develops strategies to insure customers receive appropriate solutions to their needs with Teva products.
• Anticipates and responds to changing market conditions by:
• Maintaining an awareness of biosimilar marketplace dynamics to provide guidance to direct reports to ensure business strategies are adapted to maximize opportunities and reduce threats
• Having a deep understanding of customers’ needs and expectations
• Implementing forward thinking business strategies

Territory- current territory includes Maine, Vermont, New Hampshire, Massachussetts, New York, New Jersey, Rhode Island, Delaware, Connecticut, Pennsylvania, and Maryland

*territory boundaries are subject to change based on business need

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

Education/Certification/Experience:

• Bachelor’s degree, preferably in business or a scientific discipline, MBA preferred
• A minimum of 5 years pharmaceutical/biotechnology sales and/or account management experience
• Demonstrated track record of success, leading teams and developing talent
• Experience in executing and implementing business contracts
• Strategic account management experience in developing and implementing account-specific business plans as well as the ability to coach and support others in doing the same.
• Minimum 2 years of people management experience preferred
• Buy-and-bill experience highly preferred

Skills/Knowledge/Abilities:

• Effective verbal and written communication skills and organizational abilities
• Understanding of financial concepts and contracting issues specific to pharmaceutical distribution
• Understanding of patient drug access, and healthcare provider payment/payer reimbursement
• Understanding of ASP, NCR, and reimbursement dynamics within IDN and clinic spaces.
• Ability to travel within region on a regular basis which will include frequent overnight travel

PHYSICAL REQUIREMENTS:

Occasional:

• Sitting for extended periods of time at work station or mobile equipment.

Visual Acuity:

• Perform activities such as computer work, preparing and analyzing data, and extensive reading.

WORKING ENVIRONMENT

• May be required to wear personal protective equipment (PPE) as needed on site visits (i.e. safety glasses, hearing protection, gloves, etc.).

The annual starting salary for this position is between $148,000 – $194,000 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 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.

o Support process development, optimization, and scale-up of sterile and biologics manufacturing processes.o Implement process improvements, new technologies, and innovations in the sterile and biopharmaceutical production lines.

o Ensure manufacturing processes meet all regulatory requirements (FDA, EMA, ICH, GMP, etc.) and industry best practices.
o Conduct risk assessments for sterile and biologic product manufacturing and implement mitigation strategies.
o Support Preparation of technical reports and documentation to support regulatory filings and inspections.

o Lead the MS&T efforts in the launch and commercialization of new biologic and sterile products, ensuring smooth transitions from R&D to production at global manufacturing sites.
o Collaborate with cross-functional teams, including R&D, Quality, Regulatory, and Supply Chain, to ensure timely and compliant commercialization of products.
o Oversee the preparation and review of technical documentation, ensuring all regulatory and quality standards are met for launch
o Ensure that manufacturing processes are scalable and reproducible during commercialization, addressing any process challenges that may arise.
o Provide technical support for initial production runs, managing the scale-up process, troubleshooting, and process optimization to guarantee product quality and supply continuity.
o Support the development and implementation of launch strategies for global markets, working closely with regional teams to align manufacturing processes with market requirements.

o Lead continuous improvement initiatives and incorporate cutting-edge technologies to improve product quality, efficiency, and cost.
o Foster a culture of innovation within MS&T through the application of novel technologies and methodologies (e.g., automation, advanced analytics).

o Master’s or Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, or a related field.
• Experience:
o Minimum of 10 years of experience in Manufacturing Science and Technology, with a strong focus on sterile products (injectables, biologics, etc.) in a GMP environment.
o Proven expertise in biopharmaceutical manufacturing processes such as cell culture, fermentation, purification, sterile fill-finish, and packaging.
o Extensive knowledge of sterile product technologies, including aseptic processing, validation, and cleanroom environments.

o Expertise in process design, process validation, and process optimization.
o Familiarity with modern technologies such as single-use systems, automation, and continuous processing.
o Advanced understanding of regulatory requirements and industry guidelines (FDA, EMA, ICH, GMP).

o Ability to work in a fast-paced, global environment with multiple stakeholders.
o Willingness to travel internationally as required. (30-40%)

o Experience with biologic product lifecycle management.
o Expertise in analytical techniques for biologics and sterile product testing.
o Prior experience in managing or overseeing technology transfers across global manufacturing sites.

VP, Head of TGO Manufacturing Technical Services Group

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.