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This Maintenance Technician position is on site at our East Windsor, NJfacility and is aligned with our FIRST shiftneeds; M-F, typical 8 hr shift, shared on-call.
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- Performs maintenance on equipment and systems (e.g., mechanical, electrical). Evaluates and recommends equipment improvements to increase reliability, capability and yield.
- Performs equipment condition analysis (during preventive and unscheduled maintenance).
- Troubleshoots and diagnoses equipment problems / failures.
- Prepares technical reports to document equipment modifications and equipment maintenance procedures.
- Participate in the day to day preventative and corrective tasks (mechanical / electrical / instrumentation) in-line with the planned asset lifecycle management instructions
- Maintain, service, repair and troubleshoot all equipment and installations (mechanical / electrical / instrumentation) on site as per Standard Operating
- Procedures, maintenance work instructions or engineering best practices
- Ensure that equipment and infrastructures are maintained within their safe design operating limits, and in a way that avoids danger to personnel or the public
- Ensure the correct completion of all required documentation, paper or system based, associated with own work
- Participate in the implementation of continuous improvement initiative and lean tools within the area (TOP meetings, TPM, 5S, SMED, 8D)
- Participate in the Quality Assurance and HSE programs, guaranteeing the timely implementation of corrective actions (CAPA)
- Ensure proper tidiness and cleanliness of the maintained equipment and area as well as his/her working space
- Ensure that area or his/her assign tools are kept in good shape in what regards to their functionality and cleanliness
- Participate in programs and initiatives required to ensure plant cleanliness
- Follow procedures with clear instructions; seeks clarification if they are not clear
- Work follows an established pattern, with a requirement to run standard procedures, analysis, reports or tests
- Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes
- Suggest and participate in improvements in the area in which the TM is assigned
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Ensure facility activities are carried out in compliance with all GMP, legal and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practices
- Undertake any additional tasks commensurate with the role as and when required
- Build strong cross-functional relationships which drive continuous improvements and focus on customer service.
- Gather business insights by interfacing with other industry’s peers and the supplier base
- Ensure yearly objectives on financials, process, client and people are met.
- Provide insight to project teams on business dynamics and landscape for the categories assigned.
- Share best practices across the organization.
- Hold regular Operational business reviews (internal and external) and lead functional teams to work on close the gap plans if required.
- Ensure sourcing decisions are made to the best interest of the Company in terms of price, delivery, quality and payment terms as per the existing Policies
- Lead daily negotiation processes with some involving complex technical subjects, confidentiality, intellectual property and anti-trust matters.
- Lead and support direct reports on problem solving and issues at both technical and commercial levels
- Provide oversight, guidance and coaching by holding regular team’s meetings
- Ensure right levels of Quality, Security and regulatory and legal Compliance in the Supply Chain
- Coach, mentor and challenge direct reports and key stake holders in the organization to build a culture of excellence and continuous improvement
- Build and maintain long-term partnerships with key Strategic suppliers and continuously to develop the network
- Review and approve levels of spend for purchasing agreements up to $45,000 for the Company. Review all type of contractual documents and propose them for execution.
- Manage the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity.
- Develop and propose for approval the short and mid-term goals, annual budget and budget plan in line with the corporate strategy, in order to align activities with Hovione strategic objectives.
- Prepare and propose for superior approval the annual DEPARTMENT budget, by defining the allocation of resources necessary for the development of the activity, as well as ensuring the monitoring and control of its evolution, identifying any deviations between the real and the foreseen and taking corrective measures
Hovione is hiring for a Strategic Account Manager - on site (hyrbrid role) - at our New Jersey location.
The Strategic Account Manager orchestrates and works collaboratively amongst teams (Internal and External) to foster the development and continued growth of the relationship with strategic customers. Strategic Account manager will be responsible for account plans, future growth and developing strategies to help the organization and the client evolve as partners. The main function of this role is to deliver excellent service and contribute to the long-term growth strategy of Hovione.
- Managing Strategic account portfolio
- Establish strong, long-term client relationships
- Communicate with major clients on a regular basis and respond to specific queries
- Suggest solutions and innovative ideas to meet client needs
- Handle complaints and problems in a timely and effective manner
- Act as the liaison between key customers and internal teams
- Identify and approach new potential strategic customers as required by the organization
- Monitor sales performance metrics per account
- Prepare monthly, quarterly and annual reports and forecasts
- Acquire a thorough understanding of key customer needs and requirements
- Expand the relationships with existing customers by continuously proposing solutions that meet their objectives
- Ensure the correct products and services are delivered to customers in a timely manner
- Serve as the link of communication between key customers and internal teams
- Resolve any issues and problems faced by customers and deal with complaints to maintain trust
- Play an integral part in generating new sales that will turn into long-lasting relationships
- Coordinating and technically leading the Pharmaceutical Development projects ensuring perfect execution, customer satisfaction and the achievement of the established objectives;
- Promoting, continuously, innovation and gains of knowledge within the company, delivering on the R&D Plan and the company’s strategy;
- Contributing with technical expertise to expand the IP, product and methodology/technology portfolios;
- Developing, scaling-up, registering and validating safe and efficient processes and products.
- Communicating with clients and other parties as RD representative, including promoting the company internationally through presentations at conferences, through patents and written articles;
- Participating in the technical assessment of projects and technologies, while supporting technically the sales force;
- Complying with regulatory standards, Quality, HSEE, cGMP policies, Hovione policies and legislation.
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
- Plan, coordinate and supervise the work, with other managers of the area, and manage own team to ensure that the deliverables of each project are dealt in the team within the timeframes defined, with the appropriate quality and according to cGMP and that an outstanding service is provided to all customers (internal and external)
- Assure that all TMs of the team have suitable training in order to guarantee the best possible support to the customer (internal and external)
- Ensure an appropriate information flow between the laboratory and the several internal and external customers
- Participate in external and internal audits
- Approve analytical test methods, reports, protocols and other documents related to the laboratory (as applicable)
- Approve raw material, intermediate and finished product batches, stability samples, validations and/or all samples sent for QC to perform analysis
- Approve In Process and COL samples when necessary
- Assure the availability of International standards and Hovione internal working standards with adequate calibrations/qualifications
- Manage International/In-house Primary and Secondary/Clients' standards and reserve/retention samples
- Assure the qualification of the laboratory equipment and validation of analytical methods, approving the protocols and / or respective reports
- Discuss and propose specifications for raw materials, and intermediate and finished products
- Ensure proper management of all defined stability programs in terms of protocol preparation, inventory management, analytical testing execution and data release
- Ensure that corrective and preventative actions are defined and implemented as a result of deviations occurred in the Area, and of internal and external audits
- Keep up to date on new analysis techniques relevant to the laboratory, by means of literature, training, seminars or conferences
- Assure the timely execution of the preventive maintenance program and execution of corrective maintenance.
- Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity
- Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with area strategic objectives
- Monitor Communication´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures
- Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Continuously raise our profile of company in the industry as Drug Product Development experts seeking to be the preferential partners to target pharmaceutical companies.
- Bridge Chemistry and Final Dosage Form and therefore contribute decisively to offer a fully integrated package, attractive to both Small and Large Pharma;
- Continuously improve the performance of the DPD group, by being energized with breaking new ground every day and by providing an outstanding service to our partners.
- Ensure that activities are performed in an increasingly efficient manner and with the existing resources and within the agreed budgets
- Supervise DPD projects ensuring perfect technical execution, customer satisfaction and the achievement of the established objectives.
- Promote continuously innovation and gains of knowledge within the company, proposing new differentiators (e.g. novel technologies or methodologies) for the company.
- Promote the company internationally through presentations, patents and scientific papers.
- Ensure all DPD activities are carried out according to Hovione HSE policy
- Establish the technological strategy within his/her Group
- Implement new methodologies within the DPD Group
- Train team members in other CRD sites and guarantee common standards
- Coordinate the work in the laboratories of the DPD group
- Establish career development plans and training plans
- Support technically the sales force and the Business Unit
- Assess technically new projects
- Supervise all projects within his/her Group
- Write and approve technical reports
- Prepare documentation concerning manufacturing processes, operating manuals and procedures.
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The series of investigative activities to improve existing products and services or to lead to the development of new products and services for Hovione or for our client base. It may result in ownership of intellectual property such as patents. It is the key driving force of innovation and science in the organization, managing new ideas and innovation across the company.
Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product.
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Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
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Be a liaison between the Assessment Group and the client when discussing the scope of work of analytical projects. This includes TTC projects and projects from other sites where his/her input is considered relevant. Determine the amount of work/effort that is required to accomplish a scope of work and propose solutions that meet and exceed the Client’s expectations.
- Work as an advisor for analytical challenges that take place in the global CRD organization.
- Be the analytical contact for all the projects run in the TTC. Participate in team meetings and actively suggest analytical improvements to the work that is required or delivered to a particular client.
- Develop new analytical methods that are scientifically sound for the different projects run in the TTC.
- Be a scientific leader in investigations of deviations incurred in the analytical area.
- Be a mentor to less experience members of the analytical community at the TTC and CRD and help develop their capabilities, particularly of any direct reports under his/her supervision.
- Work closely with the R&D, QC and QA groups in order to assure that the analytical work done is the most appropriate for the chemistry at each stage of development.
- Promote compliance on Health, Safety and Environment in the area and activities.
Assures the maintenance of process analytical tools (PAT) methods and performance in the manufacturing assets in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the area of PAT and contributes with technical expertise to optimize PAT applications.
- Provide technical support (process analytical and statistical) in commercial projects;
- Monitor and maintain successfully PAT tools and practices
- Participate in the Technology Transfer and scale-up of projects to Pilot Plant and Manufacturing Areas
- Write reports and relevant documentation related with the use of PAT and related methods;
- Promote, continuously, best practices, innovation and knowledge sharing within the company;
- Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Propose improvements to the area as appropriate and solve problems
- Make quality and timely decisions within the Modelling & PAT tasks under her / his responsibility
- Gather relevant data to inform the decision makers regarding complex issues
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.