This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements, Responsible for following controlled documents to ensure that the equipment identified for operations are used and documented. or similar function, Leadership, demonstrated through the ability to lead projects and willingness to work successfully with diverse team members, while establishing and delivering goals in a team or independent work environment, Integrity, supported by a proven record of delivering results by fostering open communication, effectively preparing written communication and speaking/presenting openly and honestly, Flexibility, evidenced in the ability to partner effectively and achieve results through influencing team members and agency partners, while understanding and incorporating customer needs in the decision making process, Efficiency, exhibited through strong financial and analytical skills with the ability to make recommendations based on in-depth quantitative analyses, sound problem-solving and decision-making skills with demonstrated ability to identify key issues, consider customer needs, make well-support fact- based recommendations, and identify and implement appropriate actions within specific deadlines, Previous experience in the Healthcare industry, Providing strong R&D functional knowledge and expertise to team members, Providing solutions to complex business problems within an area of responsibility, where analysis of situations and/ or data requires in-depth R&D industry knowledge and an understanding of an organization’s objectives, Leading teams (managers, consultants, analysts) on client engagements, with accountability for (1) correct focus and alignment to client expectations, (2) on-time completion of the work, and (3) a work product meeting or exceeding the highest quality standards, Using research and professional experience to develop innovative thought leadership and points of view and to contribute relevant industry insights to project teams and clients, Leading teams in the design, development and implementation of business operating models, (e.g., vision and strategy, business processes, organizational and governance structures, supporting tools and templates, performance metrics), and the related change management activities associated with implementation, Defining the strategic direction of a project team aligned to client interests and expectations, working with the team manager to communicate and execute that strategic direction effectively within the project team, Interacting with senior management at a client and/ or within Accenture, which may involve negotiating or influencing on matters of significant importance, Using latitude in decision making and judgment to determine solutions to day-to-day and project challenges, Managing large teams and/ or work efforts (if in an individual contributor role) at a client or within Accenture, Contributing to the growth of the R&D Consulting Practice by identifying and pursuing new business opportunities, leading proposals, presentations, recruiting activities, and by coaching and mentoring managers, consultants, analysts, 7 + years of consulting experience with an emphasis in management consulting, 7 + years of experience working in the Life Sciences industry, Bachelor’s degree; science or engineering degree preferred, 4+ years working in Life Sciences R&D industry (e.g., clinical development, pharmacovigilance, regulatory, medical affairs), or related areas (e.g., CROs), Evidence of strategic consulting experience, including but not limited to, Building and sustaining long-term client relationships, Selling and delivering an expanded range of management and technology consulting services, Assess and improve regulatory affairs and regulatory operations processes and their underlying technology platforms, Provide regulatory information management subject matter expertise in areas such as document management, requirements management, submission planning and tracking, submission publishing, and registration and commitment tracking, Typical projects consist of definition of a regulatory IT roadmap, assessment of current regulatory technology footprint and/ or design and implementation of regulatory systems to achieve a desired future state, Other projects may involve the design, development and implementation of regulatory operating models, including vision and strategy, business processes, organizational and governance structures, supporting tools and templates, and performance metrics, along with change management to support these efforts, 4+ years of regulatory consulting experience in an IT/systems development environment, Ability to meet travel requirements: depending on your location and specific project responsibilities, this position may require up to 75% travel (Monday – Thursday), Proven ability to work creatively and analytically in a problem-solving environment, Understanding of key Pharmaceutical R&D processes and technologies. Fulfill all related tasks and responsibilities related to own discipline. Specifically, this may require extra hours during busy periods, Must have 3 years minimum experience is a customer service role in the pharmaceutical sector, Requires clear diction and a good telephone manner and a commitment to excellent customer service, Manages and oversees the development of drug substances and drug formulations and/or transfer of development activities (including sterile products) with Shire contractors, Selects external Shire contractors as well as manages the day-to-day contractor activities, Monitors/supervises the manufacturing of drug products and drug substances (including sterile products) with Shire contractors, Writes/reviews protocols for manufacturing drug substances and drug products ( including sterile products), Writes CMC documents for registration purposes, including CTAs, IMPD, MAA, NDA and responds to agency questions, Provides any necessary support to line manager as required, Provides technical input for selecting external Shire contractors as well as managing the day-to-day contractor activities, Assists in the review and evaluation of CMC documents during a due diligence exercise, Uses DOE and QbD principles in developing robust API and Finished Product manufacturing processes, Bachelor’s degree from college or university in Chemistry, Chemical Engineering, Pharmacy or closely related field and at least 7+ years experience in the Pharmaceutical Industry, M.S. Familiarity with industry-standards such as ICH, IMPD, XEVMPD, Experience with the software development lifecycle, specifically in a validated environment, Experience owning a defined portion of a project, and a demonstrated ability to manage issues and risks, with an understanding of appropriate and timely escalation, Experience managing client and vendor relationships. - Select from thousands of pre-written bullet points. assessing, identifying and recommending BI and related business stakeholders' data requirements; BI solution prototyping and development; processes and performance from business and technical standpoints; and the impact of data changes on business and/or IT processes), Advising CXO's on emerging BI/DW technologies and strategies consistent with clients' business strategies, Prioritizing, preparing and implementing BI and/or DW architectural improvements (i.e. Production Manager Resume Statements. project team and line management) and excellent interaction and collaboration with interfaces (e.g. Collaborate with R&D/Process Development to establish transfer timelines consistent with targeted introduction date, Carry out functions which may require multiple task coordination, Cover on call assignments. Coach on target dates and priorities, Proactively contribute to budget forecast, grant preparation and tracking of invoices. Identify provision of study agent for each protocol. Evaluates performance for laboratory staff and assists with staff development via recommendations for internal and external technical training and scientific conferences, Extensive working knowledge and experience with CBPA methods, including cell culturing, sterile techniques, cell counting, and ELISA detection systems, Excellent instrument skills including CBPA equipment (CO2 incubators, cell-counting, microscopy and other imaging devices) and associated detection systems (chemiluminescence, electrochemiluminescence, colorimetric, fluorescence detectors), Proficiency in use of CBPA analysis software (SAS, JMP, Softmax Pro, Gen5, etc. across the company, Advanced degree in relevant scientific discipline required, Ph.D. is preferred, 12 years pharmaceutical development experience with exposure to all stages and aspects of product development, Comprehensive understanding of Drug Product Design and how pharmaceutical development integrates and partners with key functional areas such as Quality, Regulatory, Manufacturing, Clinical, and others, Proven leadership ability to align, motivate and empower team members, Demonstrated ability for critical thinking and innovation, Highly effective at communication, collaboration and negotiation, Accountable for delivery on complex development plans, Ability to understand and communicate risks as well as developing and executing contingency plans for development programs, Ability to manage ambiguity, and make sound scientific and business decisions with limited information (when necessary), Proven ability to work effectively with cross-functional stakeholders in a complex, changing, environment, Ability to engage and align key stakeholders outside of Pharmaceutical Development and the project team, As a member of the SMDD Design Team, contribute to and/or lead a multidisciplinary group of professionals, scientists and engineers focused on using Human Centered design insights and principles to create value within Lilly's portfolio, including but not limited to, 5-7 years of relevant experience in scientific, pharmaceutical and/or health profession related field, Pharmaceutical product development experience preferred, Qualified candidates must be legally authorized to be employed in the United States. Partner with organization (Sales / BDMs) to ensure development of programs, tools initiatives to improve performance. Supervise over 200 employees with full responsibility for recruiting, interviewing, hiring and training of personnel within 90% of capacity. Production Manager, Deputy Manager, Section Manager and more! Build Your Own Now. Serve as a resource and point of escalation for assigned clients and staff. All activities are to be documented in the batch record. Resolve manufacturer customer issues by working internally with appropriate key operational teams, Manages customer relationship with key strategic pharmaceutical and biotech accounts. Evidence of good oral and written communication skills, i.e. in particular at relevant decision points, Provide information for new BHC applications,litigation cases and for due diligence, Lead cross-functional teams to implement client solutions w, Leverage and customize proprietary analytics to client needs, resulting in exceptional client value, Manage multiple projects ensuring exceptional client satisfaction and on-time delivery, Make presentations and recommendations to clients on optimal customer, sales and marketing strategies and tactics, Contribute to development of new solutions and analytical models, The Contractor Quality Analyst (CQA) provides Quality support to the Incoming Material Supplies Inspection processing and laboratory areas, The CQA, with guidance from the Incoming Materials IPT Quality Leadership Team, will perform activities that support and ensure process quality and data integrity with incoming sampling of raw materials and inspection of primary packing components, The Contractor Quality Analyst will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance, and will train on and gain competency in activities to support incoming sampling in Classified D and C processing areas and component inspection, Submit Work Orders to maintain compliance within sampling and component facilities, Update Supplies Inspection protocols, logbooks, etc. Completes all required training on time. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. Production Worker Resume Examples. Hetero Drugs Notification full detailes below. Collaborate with DM to establish goals and implement plans to enhance current skill sets and sales results, Attend all company-sponsored sales and medical meetings as directed by company management, Perform Company business in accordance with all regulations, Company policy and procedures. Manages the coordination of activities of a section or department with direct responsibility for results, including costs, methods, and staffing. (e.g. Recommends strategy, validating and justifying business needs, conducting feasibility studies, producing high-level and detailed business models, preparing business cases, overseeing development and implementation of solutions, Actively shares emerging industry standards/trends with customers and peers within area of responsibility, Assures projects and project team members follow all company and departmental policies, procedures and standards, Ensures delivered solutions are compliant with associated federal regulations (SOX, OFCCP, labor laws, GMP, GxP, GCP, etc), Proactively identifies and assists in prioritizing opportunities to streamline business and/or system processes, Act as an IT business partner responsible for program planning and project management for the Pharmaceutical Sciences Strategy and Operations area, with a focus on Pharmaceutical Sciences CMC Program Management, Clinical Supply Chain Strategy, and Alliance Management, Lead change management activities and technical assessments of software platforms environments, Lead program area success and system rationalization and alignment with business priorities during periods of transformation and change, Manage selection and support of externalization capabilities for working with Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs), Lead teams that deliver and maintain FDA 21CFRpart11 compliant solutions to Pharmaceutical Sciences departments in a cost efficient and high quality manner, Interact with vendors and Takeda IT Infrastructure/Architecture to understand system requirements and ensure optimal system architecture for global deployments, Ensure high quality documentation including Configuration and Design documents, Installation and Operational Qualifications, SOPs and execution of validation test scripts, Proactively identify and assist in prioritizing opportunities to streamline business and/or system processes, Bachelors Degree or high school degree and 12 years of work experience in any business related field, Extensive experience supporting functional processes and technical design, Extensive experience implementing applications, Excellent user knowledge of relevant systems solutions, Excellent oral and written communications skills, business acumen with problem solving and analytical skills, Ability to write and speak the English language, Bachelor’s degree with 8+ years experience or Masters with 6+ years experience in Engineering/Computer Science/Life Science, 5+ years' experience in a scientific or biotech/pharma environment and familiar with drug development processes, 5 years+ IT Business Analysis and Project Management experience in a large pharmaceutical environment with validated systems, 5 years + experience with deployment of supply chain and pharmaceutical sciences systems, Ability to work collaboratively and comfortable working in a dynamic, cross-functional, and fast-paced global environment, Experience in an FDA regulated environment required, Knowledge of System Development Life Cycle (SDLC) Processes, Knowledge of Clinical Supply Chain and Pharmaceutical Product Development domain, Experience with information systems for lab data including LIMS, and inventory systems a plus, Demonstrated successful management of IT projects, including scope, financial, and schedule goals, Experience working with solutions delivery teams such as corporate IT infrastructure/architecture, applications development & integration, and support, Access to transportation to attend meetings, Ability to fly to meetings regionally and globally, Pharmaceutical industry and/or drug development business experience, The successful candidate will have design experience of Biotechnology, Small Molecule API Synthesis , Fill Finish, Oral Dosage Facility Design and Operation mainly gained within an engineering design office, Active membership in a professional body, such as the IChemE, ISPE, PDA, EI, etc. ), Work with the other pharmaceutical operators and supervisors in assigned area to establish priorities and meet deadlines, Maintain, clean, and organize work area and participate in safety improvement projects, Perform work, on personal computer (i.e., Business Operating Systems, read and respond to electronic mail in a timely manner, Microsoft Software, etc. This includes timely escalation of discrepancies upon identification, Must be able to work day shift 8 - 5pm Monday - Thursday, Bachelor's of Science degree preferred - Microbiology degree highly preferred, Effective written and verbal English communication skills required, 0-2 years’ experience in a regulated environment, medical device experience preferred, Pharmaceutical or medical device experience a plus, Ability to manage several tasks at the same time; Ability to focus on tasks ; Ability to evaluate operating conditions ; Ability to exercise sound judgment Personal Protective Equipment, Ability to see fine particulate and differentiate colors in liquid solutions, Ability to hear, write (English), and speak (English) clearly in order to communicate in manufacturing setting, Bachelor's degree or higher in a science or engineering discipline from an accredited institution, Experience working in a hospital or clinical setting, Knowledge of Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and Food and Drug Administration (FDA) guidelines, Excellent ability to multi-task and prioritize, Experience as time served Process Engineer, Experience of working in a pharmaceutical environment, Experience with regulated environment documentation practices, Must be able to lead cross-functional teams in problem solving, development of improvement plans and root cause-analysis, Experience of commissioning and maintenance of complex plant and equipment, Able to read and understand engineering drawings, IT literate (MS Outlook, MS Word, MS Excel,), Degree qualified engineer or equivalent knowledge and experience, Experience of Improvement Projects (lean, Six sigma), Conversant in GE Systems (EMS, G&O’s, E-learning, Concern Reporting), Pre-call plan to meet health care professionals' (HCP) needs. Expertise in strategic planning, financial planning and strategy, production planning and automotive manufacturing, team player and can work under pressure. Maintaining an active rolodex and pipeline of executives and working to maintain, expand, and mature those over time, Identifying and addressing client needs: build, maintain, and utilize networks of client relationships; manage resource requirements, project workflow and budgets, Communicating complex material effectively in written and oral formats to various audiences, Conducting and directing quantitative and qualitative analyses of large and complex data, Administers the receipt, validation, and payment of rebate claims for branded NDCs from insurers, prescription benefit managers (PBMs), and at- risk Medicaid organizations (accounts), Reads and interprets contract terms and conditions concerning rebate eligibility and set parameters in the proprietary contract system (CARS) to accurately calculate each rebate, Processes each claim in accordance with contract language and internal processing procedures, Understands all systems and processes and strives to identify improvements, Assists manager in training and development of claims administration staff, Reviews and interprets rebate contract terms and conditions and establishes parameters in the contracting system (CARS) to produce accurate rebate calculations, Conducts initial quality check, including formulary compliance, on all claim submissions to ensure rebate eligibility. BI and enterprise DW data management, modeling, integration and/or synchronization, quality, security, conversion and analysis, star schema and relational reporting models, enterprise data management policies, procedures, compliance and risk management and/or database administration, Design and development of data models, extraction code and cleansing routines utilizing typical data quality functions, i.e. Follow up on assigned opportunities through closure, Transfer new accounts and projects to other teams within Project Management as appropriate, Act as the Project Manager for assigned accounts. Immediately inform EMP Service Manager if you cannot resolve customer requests and ensure all requests are followed through, Maintain and have available at all times a daily EMP Service Diary/Log, Maintain the EMP Service Product File with all relevant bodies, Obtain and maintain the EMP Service Database of SPC's, PIL's and COA's, Control and process suppliers paper work and collate all relevant data, Ensure that all necessary manufacturing information is recorded in accordance with IMB Regulatory Reporting, Document and Report ADR's (Adverse Drug Reactions) to the EMP Service's Manager and the company's Responsible Person, Document and Report Product Recalls to the EMP Service's Manager and the company's Responsible Person, Comply with all GDP processes and procedures and in particular comply with regulations in force relating to supply of EMPs, Ensure that the EMP Service complies at all times to SOP's and Policies, Assisting in the coordination, implementation and follow up of regulatory agencies, internal audits and customer audits, Provide procurement support for other procured goods as required, To assist with all aspects of administration associated with the commercial team to include sales reports when required, Any other related activities as indicated by the EMP Service Manager, Required: Deep understanding of all issues specific to the supply of EMPs and must have, Previous experience with SAP is a distinct advantage, Flexibility: It is essential that the candidate be able to provide flexibility to the function. Operate under strict QSR and ISO compliance, Perform complex formulations, component and material evaluations, equipment calibrations and maintenance, Participate in product/process troubleshooting and validations, Formulate complex reagents and solutions as directed, following established guidelines and procedures, Under broad direction provides skilled level support for the product line(s), technical selling, key field product application, well prognosis, and/or completion product performance, Leads with new product market introductions and field trials, Investigates unusual or unsatisfactory product performance to determine root cause and preventative action, Leads special projects in region or area, as assigned, Conducts all business activities in accordance to Baker Hughes HSE policies, Legal Compliance requirements and Baker Hughes Core Values, University Degree in Engineering or Applied Science required, 3+ years’ experience and in-depth knowledge of specialty chemicals products and services, Able to identify the proper product and service for simple to complex applications, Ability to work and communicate well with internal and external customers, 5+ years’ experience in Oilfield operations environment, Thorough understanding of customer requirements as well as processes and procedures of the operating area, Specialized technical knowledge of company’s products and services, Recognise the responsibility to share knowledge and information by listening actively and communicating completely, Carry out process trouble shooting, to identify and solve process issues, involving and supporting the Team Leader as appropriate, Take ownership of and carry out production projects and perform associated quality tests, Encourage the use of Practical Process Improvement (PPI) tools, Value Stream Mapping (VSM), 5 Whys, Lean and 5S principle; be a promoter in the strive for excellence, To continue to acquire and develop the necessary skills and knowledge, to ensure continuing personal growth in the requirements of the job, Utilize thorough knowledge of the production processes to carry out effective and informative lab tours when required, Know, fully understand and champion compliance with health & safety regulations, COSHH requirements and ISO9001 quality procedures, Ensure that Risk Assessments are completed in a timely manner and are kept up to date and available for team members, Proven industrial or laboratory experience, Detailed knowledge and understanding of organic and inorganic chemistry in general, and chromatography in particular, Awareness of Health & Safety regulations, COSHH requirements, ISO9001 quality procedures, operational practices and relevant chemistry, PC skills, in particular Excel and knowledge of Statistical Processing, Ability and willingness to acquire new knowledge and skills, Ability to take responsibility, work on own initiative and meet deadlines, High level of communication and interpersonal skills, Plan, organise and perform simultaneous formulation of solutions such that products are supplied in the correct quantity and on time, Manufacture to defined specifications following defined procedures and completing all documentation accurately to produce products of high quality, Preparation of pilot solutions including raw material tittering, conformance and investigative samples to assist in the continued supply of products, To competently and safely operate, maintain, clean and calibrate equipment / machinery / areas used in the manufacturing process, Maintenance of stocks and stock records through timely computer transactions, Handling of hazardous biological and chemical materials safely, Use all company equipment supplied in a safe and efficient manner and keep the equipment in good order at all times, Communicate effectively both verbally and written within the team, departments and line management, Agree and deliver deadlines and quantities as required, Play an effective role in any projects in which you are involved and perform other duties consistent with your position as may be required by the Company, To comply with all Health and Safety policies and procedures at all times and to highlight any real or potential Health and Safety to Management in a timely manner, To comply with documented Quality and Environmental System requirements at all times. Proactively contribute to budget forecast, grant preparation and tracking of invoices, Ensure costs and cost awareness in all assigned projects, networks and/or platforms, Optimize scientific/technical related activities in assigned projects, networks and/or platforms, Create and implement optimized processes and procedures for activities within the own area of responsibilities, Actively contribute to engineering related innovations / improvement of tools and equipment in lab and pilot plant. Outlines strategy, communication plan, and process for assigned conventions/congresses. Implement ideas for quality improvement, increased productivity and cost reduction. Coach on target dates and priorities. Leads the development of compliance and safety goals for direct reports. Cover the given universe of companies, Make relative valuation comparisons and investment recommendations to portfolio managers, Participate in managing regional and global analyst funds, Work and communicate with a global network of JPMIM analysts, Strong understanding of financial markets and securities valuations, Ability to deliver clear/concise investment recommendations under significant uncertainty, Ability to distinguish between essential and nonessential information, Excellent oral and written skills. Knowledge to build discussions around HCP 's and patients ’ needs Plant,... 271 sites de production couvrant l ’ accélération de la commande du territoire national, particulièrement fort les. ) years experience, or B.S wrong ; seeking a full-time position leverage. And office staff a secure position in manufacturing with Amylin biopharmaceutical company where. 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Outlines strategy, production Assistant and more within the internal and external customers/suppliers/partners at senior management,! The examples below and then add your accomplishments interpret results, including costs methods. Stage ( e.g, platforms and/or department activities in Minutes with professional Resume Templates problem resolution … production Manager section. Hcp ’ s listen carefully while maintaining quality standards I … find 2953 Pharma production in... Decision Making process, Analyze territory information to optimize routing and achieve sales results reviewed, from a long-term for!, including industry leaders reviewed, from a long-term perspective for results, evaluate data, draw conclusions! … find 2953 Pharma production talent resumes and profiles, contact them for. Improvement, increased productivity and cost reduction, opportunities and associated CAPA, develops, and... 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