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- Responsible for overall sales, promoting and supporting the organisation’s services portfolio.
- Activities include developing and implementing sales strategies; managing and growing existing customer relationships; and monitoring customer and competitor activity and industry trends.
- Builds and maintains effective long-term relationships and a high level of satisfaction with key senior-level decision makers at a biotech and large pharma accounts.
- Identify, develop and close new sales opportunities with existing customers.
- Creates demand for Hovione’s CDMO services.
- Adapt departmental plans and priorities to address commercial challenges.
- Proactively communicate and support departmental managers as needed.
- Achieve sales targets and ensure project delivery for assigned portfolio of customer accounts.
- Build internal network within Hovione and customer accounts.
- Lead negotiations of CDAs, Master Service Agreements and Commercial Supply Agreements for allocated accounts in close collaboration with the Regional and/or Senior Directors in Sales
- Coordinate with the global regulatory, production, quality, supply chain and R&D groups to provide a superior level of customer service.
- Analyze data, including demand forecasting, within Hovione´s Customer Relationship Management system for Europe to ensure accurate forecasting and reporting.
- Identify complex market trends and demands and proposing ideas for new technology and services.
- Monitor customer account and market activity and provide concise and insightful analysis on customer dynamics, market developments and competitor activity.
- Optimize the relationship with established clients through both strategic and tactical means including Key Account Plans, Account Growth Plans, Periodic Business Reviews, client visits and Satisfaction Survey Action Plans
- Attend and represent Hovione at key Trade Shows
- 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.
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Actively contribute to managing profitability through the deployment of controlling best practices across the company. Responsible for the timely, accurate, and insightful analysis and reporting of financial information to key stakeholders. Drives the long-term financial planning of the company, including the investment program.
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- Supports Business Segment Leadership and Global Sales in achieving its operative and strategic goals
- Financial support at acquisition of large CDMO projects
- Analyze and assess of strategy, business development, and business opportunities and risks of the Business
- Support for essential control processes (such as creation of the specified goals for mid-range planning, reporting)
- Participation in the continued development of the strategy
- Economic assessment of investments and portfolio measures
- Preparation of decision recommendations for the Company Management
- Support for and assessment of market / competition analyses
- Actively discuss and support customers with their technical and scientific issues within the projects assigned
- 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.
- Gather relevant data to inform the relevant stakeholders regarding complex issues
- Promotes the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Be the interface between the analytical team and supporting areas to coordinate the priorities and the needs of projects to ensure that the timelines of the analytical work are met (such as method development, method validation and batch release)
- Prepare and revise analytical reports and protocols
- Discuss and review analytical data generated by the team
- Actively participate in investigations and propose corrective and preventive actions (CAPA)
- Support client visits and audits
- Provide training internally and to other areas as required
- Ensure all assigned tasks are planned and delivered on time, 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 Analytical tasks under the scope of this role
- 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.
- Defines and implements business processes that assess overall performance, identify business drivers, benchmark against relevant KPIs, identify improvement opportunities and promote business process optimization.
- Defines, produces timely and challenges reports that address performance against budget, profitability, cost, efficiency and risk.
- Prepare, monitor and control the annual departmental budget under responsibility to ensure expenditure is in line with the company business plan
- Administer all departmental financial and operational information in the appropriate systems
- Develop and monitor business performance metrics for the department, acting as a partner of managers and directors and understanding the department or area strategic challenges
- Execute regular and specific complex reports for the department related with operational and financial KPIs, as requested by managers and directors
- Conduct forecasts with financial and operational information
- Support project managers within the department, analyzing project costs to ensure that budgeted costs are in compliance
- Conduct specific analysis related with the department, improving data reporting and analysis
- Provide financial and accounting advice to directors and managers within the department
- Master controlling processes and tools
- Manage complex projects/ analysis with significant impact on business
- Make quality and timely decisions based on multiple sources of data
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
- 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)
Delivers win-win cost-effective solutions on time and in full through a Team of Project managers leading focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and team members. Enable and coach the Project Managers to lead the project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Maximizing financial performance and optimizing customer satisfaction are central to the function.
Main responsibilities:
- Lead the development of the Project Management area vision, strategy and measures, ensuring these are aligned to the overall business, in collaboration with the PMO Director.
- Develop and sustain standardized PM processes, implemented in a consistent and repeatable manner.
- Oversee the integration of program and project processes
- Develop organizational governance frameworks, hierarchies, and relationships
- Monitor portfolio, program, and project performance (actual versus planned) and key performance indicators.
- Implement a PM continuous improvement system, to optimize the existing processes and adapt to new challenges and realities, in the line with the overall Corporate PMO strategy
- Facilitate organization-wide stakeholder engagement and agreement, actively contributing to customer satisfaction
- Control area deliverables and ensures they are completed on time and in full and within budget, thereby exceeding customer expectations
- Assign program and project managers to programs and projects
- 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 area 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.
- Active member of the site leadership team influencing the strategic direction of the site and bringing the customers’ perspective to the attention of the SLT
- Comply with all applicable 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
- Manage a multi-disciplinary team to carry out technical services in DPCM group (DPCM - drug product continuous manufacturing).
- Ensuring proper development, transfer, validation, and & troubleshooting of spectroscopic and non-spectroscopic PAT methods, and orchestrations
- Provide technical support to the DPCM operations area (maintaining & troubleshooting equipment challenges)
- Interact with new customers to demonstrate and promote the value of Continuous Manufacturing
- Support the Business development team by drafting technical SOW’s for new business opportunities
- Approve changes to the facilities under his (her) responsibility.
- Assure compliance with HSEE and GMP policies
- Comply with all Federal, State and Local requirements, namely: EPA, OSHA and FDA.
- Staff the team according to the company strategy for the area, both in terms of headcount and skill set.
- Supervise the area projects aiming 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 tools or methodologies) for the company.
- Ensure continuous communication, training and development of team members, so that the members are engaged and play a valuable role in the development of robust and profitable processes.
- Raise the profile of the Company through technical presentations/articles in the area of Continuous Manufacturing.
#drugproductcontinousmanufacturing, #pharmaceuticalmanufacturing, #CDMO
#solidoraldosing
Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. 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.
- Perform project analytical tasks for complex projects: e.g., method development, method and specification creation; method transfer, protocols and reports preparation.
- Solve complex project analytical problems
- 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
- Discuss actively with customers on technical and scientific issues
- Supervise the activities of less experienced colleagues in the work group
- Prepare and discuss complex product specifications
- Conduct and supervise analytical investigations and contribute in the definition and implementation of corrective actions
- Support audits and client visits
- Evaluate and approve materials, supplier/qualification
- Provide training internally and to other areas as required
- Master Analytical Chemistry processes and tools
- Manage complex projects/ analysis with significant impact on business
- Make quality and timely decisions based on multiple sources of data
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
- 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.
- Liaise with Production to assure costs are executed as per plan and assets corresponds to current and future need.
- Liaise with R&D to identify promising upcoming technologies and development of customized grade
- Liaise with the Sales team in the definition of a pricing strategy
- Liaise with Procurement in the implementation of a sourcing strategy
- Managing short-term goals and the product’s lifecycle, assisting in the definition of medium and long term goal
- Implementing and managing changes to ensure customer satisfaction, safety, quality, and area’s performance;
- Developing methods to assess products strengths and identify areas for improvement (Operational excellence, sourcing, RD, etc.).
- Analyzing product risks and proactively proposing solutions;
- Working on strategy with the Marketing Team to define the marketing strategy and offering based on market needs ;
- Reporting on product performance to executive team and directors
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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.
- As subject matter expert you will lead multiple pharmaceutical development projects to ensure effective collaboration between internal & external stakeholders to meet the objectives of Hovione and our clients.
- Developing drug product manufacturing processes for oral drug products, including scale up, technology transfer and design space definition.
- Promote innovation by identifying, evaluating, and recommending new technologies and/or methodologies for Hovione.
- Strive to maintain Hovione as specialists in the field of Oral Drug Product Development through patents and scientific papers.
- Keep up to date with current global trends in the pharmaceutical industry, using this information to identify areas for improvement and opportunities for growth/investments.
- Select, evaluate, and make recommendations for new equipment to ensure practices and methodologies are aligned with state-of-the-art for pharmaceutical development.
- Create a knowledge sharing environment by mentoring the wider team in their experiments and by expanding their technical/theoretical knowledge and experience.
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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 and/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 technical transfer.
- 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.