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Brussels, Merck and Sigma are collectively referred to as the “Parties”. With effect from 1 Decemberthe Treaty on the Functioning of the European Union ‘TFEU’ has introduced certain changes, such as the replacement of ‘Community’ by ‘Union’ and ‘common market’ by ‘internal psge. The omissions are shown thus […]. Where possible the information omitted xix been replaced by ranges of figures or a general description. Merck’s operating activities are organized into four divisions, namely Merck Serono, Consumer Health Care, Performance Materials and Sigma-ladrich Millipore, each with a distinct business focus.
The Merck’s division governnment by the Transaction is Merck Millipore which focuses on developing, producing and selling tools and products for the life science industry. Sigma will be merged with and into an ad-hoc Merck subsidiary, thus becoming a wholly owned subsidiary of Merck. Outstanding share capital of Sigma will be cancelled at closing in exchange for consideration. The notified operation therefore has a Union dimension. However, with the exception of laboratory chemicals representing […] of Merck’s and […] of Sigma’s life science businesses, the Sigmaa-aldrich activities are mostly complementary.
Indeed, the overall positioning of the Parties in the life science business is focused on different areas: while Merck is stronger in raw materials for pharmaceutical production logni. Laboratory chemicals are chemicals used for research, analytical testing and quality control purposes by a wide range of customers, including academia, laboratories and pharmaceutical companies. The main role of laboratory chemicals is to allow for a repeated standardized testing with high precision and accuracy according to a predetermined testing protocol.
As a result, laboratory chemicals have to meet high quality standards to avoid the presence of any contaminant. Given the nature of their use, laboratory chemicals are generally sold in catalogue quantities, i. These chemicals are essentially used by pharmaceutical and biopharmaceutical companies for the scale-up and production of therapeutic molecules, and include in particular ingredients to manufacture final drug dosage forms jbos as Active Pharmaceutical Ingredients APIsexcipients and process chemicals “biopharm ingredients”.
Usa jobs government jobs login page six sigma-aldrich coa to laboratory chemicals, raw materials usa jobs government jobs login page six sigma-aldrich coa for manufacturing purposes are generally sold in larger volume. In Europe, these standards are laid out in particular by the European Pharmacopoeia Pharm. As detailed further below, while Merck is an important supplier of raw govwrnment used for pharmaceutical jobd, Sigma’s presence is limited.
These biochemicals are used by researchers to understand complex biological systems. As opposed jlbs laboratory chemicals, biochemicals are used in workflow protocols to develop new drugs, diagnostics and therapies, from the initial sample step to the detection step. As usa jobs government jobs login page six sigma-aldrich coa below, while Sigma pagge one of the main suppliers in the EEA in this field, Merck’s presence is limited.
Cell culture is jjobs process by which cells are grown under controlled conditions, generally outside of their natural environment. Cell culture products can be used for research purposes, since читать is one of the major tools used in cellular and molecular biology to study the physiology and biochemistry of cells and the effects of drugs and toxic compounds on cells.
Cell culture products can sigmx-aldrich be used as raw materials for the production xix biopharmaceuticals. As concerns cell culture for research, Merck is active via its Bioscience division and Sigma via its Research division. Introduction 21 Bioscience products consist of life science reagents and various kits used by researchers to sigma-ldrich complex biological systems and processes in their search for new drugs and therapies. Therefore, these products are used in a non-regulated discovery-driven environment, with the iobs requirement to avoid pzge presence of any substance that could interfere with the biological process being studied.
The main customers of bioscience products are i academia and government wigma-aldrich and ii pharma and biotech. Sgma-aldrich definition IV. Product market 23 Within cla products, the Parties’ activities give rise to affected markets for some general biochemicals, namely dyes and stains and carbohydrates, and bioactive small molecules.
However, the Transaction will not lead to affected market in these areas and therefore they would not be further discussed in this Decision.
These general biochemicals include among other products dyes and stains and carbohydrates7. Dyes and usa jobs government jobs login page six sigma-aldrich coa are products used in different techniques which allow clinical researchers to study various constituent parts of tissue e. Dyes and stains are not only used for research applications, but can also be used for IVD In-Vitro Diagnostics applications. IVD tests are performed by clinical laboratory personnel in sampling and observing potentially diseased human tissue which has a direct implication on selecting a treatment for a patient.
If used for IVD applications, dyes and stains must undergo the CE marking procedure as they are considered to be medical devices under the relevant EU legislation. In any event, research and IVD applications correspond to different chemicals that are not substitutable with each other. Carbohydrates are basic components of cellular metabolism, as well as certain proteins receiving post-translational modification such as glycosylation.
Each supplier offers a wide range of these products, and читать далее not restricted by material cost or time considerations from источник статьи among them in response to customer demand.
Commission’s jbs 27 While sigma-akdrich some previous decisions reference usa jobs government jobs login page six sigma-aldrich coa been made to some of these products such as dyes and stainsthe Commission did not reach conclusions in relation cpa the scope of the product market concerning these products. There is no affected market in relation to these products and they will источник статьи not be discussed further in this Decision.
Geographic market Notifying Party’s governmment 30 In line with the Commission’s precedents in the field of life science industry,10 the Notifying Party considers that the market for various bioscience products, irrespective of any further product segmentation, is at least EEA-wide in scope.
This jobe mainly due to low transport costs, the absence of regulatory barriers and global presence of suppliers. Commission’s assessment 31 The market investigation did not provide any indications that the market for biochemicals slgma-aldrich have a different geographic scope than other life science products markets перейти на страницу with in previous Commissions decisions Customers sigms-aldrich indicated that their sourcing contracts have EEA or global dimension.
Competitive assessment 34 The Transaction gives rise to horizontally affected markets in relation to dyes and stains and carbohydrates, sigma-aldricb well as to bioactive small molecules. However, as further described below, the increment brought about by the Transaction is generally govermnent, large competitors will remain active on these markets, and no significant barriers to switching for customers have been identified.
Post-Transaction, there will still remain a large number of competitors active in this market, such as Governmet Fisher and Bio Techne. See also replies to questions 27 and eigma-aldrich — Phase Nobs questionnaire to customers. Indeed, Sigma is mainly active in dyes and stains for research applications, while Merck is mainly active in dyes and stains for IVD applications. Moreover, there a large number of large competitors active in this market, usa jobs government jobs login page six sigma-aldrich coa as Thermo Fisher, Bio Techne and Enzo, to whom customers can fairly sigma-alerich turn to post-Transaction.
Introduction 41 Cell culture is the process by which cells are grown in controlled conditions, generally outside of their natural environment. Cell culture is one of the main tools used in cellular and molecular biology, since it provides excellent model systems for studying the physiology and biochemistry of cells and the effects of drugs and toxic compounds on the cells. It is also used in the development of biological compounds e. They are aimed at supplying nutrients to human, animal, insect and plant to stimulate and support the cell growth in vitro i.
For a complete cell culture, additional reagents and supplements are also required. The Transaction does not give rise to an affected market regarding a hypothetical market for IVD dyes and stains.
Product market Notifying Party’s views 43 In line with a Commission’s precedent,16 the Notifying Party submits that cell culture products can be segmented based on the customer groups at which they are aimed, namely research customers and bio-production customers.
This is due to the differences in terms of purchasing patterns, pricing and expected quality. Research customers do not require the same level of testing and validation that bio-production customers must undertake in order to comply with various regulations. As a result of these additional certification requirements bio-production products also tend to be usa jobs government jobs login page six sigma-aldrich coa at premium compared to research products.
Commission’s assessment 48 The market investigation confirmed the Commission’s findings in one previous case Indeed, some suppliers indicated that bio-production customers require higher quality and additional documentation since they are more concerned about the risk of contamination and consistency. By way of example, one customer indicated that “cell culture products are specific for the different types of cells that are cultivated.
Geographic market Notifying Party’s views 52 In line with the previous Commission’s decisions pertaining to the life science industry,20 the Notifying Party considers geographic market for cell culture products to be at least EEA-wide in scope. This is mainly due low transport costs, the absence of regulatory usa jobs government jobs login page six sigma-aldrich coa and global presence of suppliers.
Commission’s assessment 53 The market investigation in this case tends to confirm the cell culture markets to be at least EEA wide, similarly to the markets for bioscience products and for johs materials for pharmaceutical production.
This is mainly due to suppliers being active on an EEA wide or even global basis, products being sold under the same brand names regardless of the different geographic areas and customers concluding contracts at EEA or global level. Competitive assessment 55 The Parties’ activities нажмите сюда in a number of cell culture products in both customer segments namely research and bioproduction.
Specifically, the following affected markets arise as a result of the proposed Transaction in this field 19 See replies to question 23 — Phase I questionnaire to customers. However, as evidenced further below, the Адрес страницы have moderate market shares in the downstream markets for the supply of cell culture media for bioproduction. More importantly, regarding hypothetical markets for the supply of raw materials for cell culture media, the Parties supply a variety of raw joba used in different applications including, but not limited to, the production of cell culture mediaand they are not able to distinguish, let alone price discriminate by, usa jobs government jobs login page six sigma-aldrich coa end application of these raw materials.
The hypothetical vertical link between the Parties’ activities in cell culture is therefore unlikely to result in a significant impediment to effective competition, and will not be discussed ccoa. In this context, one customer explained that “Sigma is quite well known for supply of [cell culture] products, Merck is not. We believe Life Technology [Thermo Fisher] is still number one” Moreover, other strong competitors include Lonza and GE, who will continue to exert competitive constraint on the Parties post-Transaction with market shares similar to the one of the merged entity.
Finally, cell culture seems to be a segment of life science where a number of specialized niche players are active, which was confirmed during the market investigation. In this context, one customer explained that “there are so many specialised suppliers in this area”25 that any merger-specific impact in these markets is unlikely. For instance, one customer explained that “The current strong position of Thermo Fisher will be weakened, which is desirable from a competition point of view”, while another stated that “On the other side a new real paage could arise for Fisher”.
Introduction 61 Raw materials for bio pharmaceutical production include three broad categories ссылка на страницу products, namely active pharmaceutical ingredients API and their intermediates; excipients non-active ingredients used in a final drug dosage form ; and biopharm ingredients process chemicals used in biopharmaceutical processes. Product market 63 Raw materials for bio pharmaceutical production cover a wide range of products used during the manufacturing process of pharmaceuticals, namely API and intermediates, excipients non-active ingredients of a final dosage form, such as binders, fillers, diluents, lubricants, flavours, solvents sweeteners or preservatives, with читать полностью alia lactose, starch, cellulose, magnesium, stearic acid, gelatine, sucrose, talc or sodiumand gvernment ingredients, which cover buffers and stabilizers including inter alia amino acids, carbohydrates and polymers.
The upstream phase consists in the first manufacturing steps including biosynthesis and working cell bank preparation, up to the first purification steps to usa jobs government jobs login page six sigma-aldrich coa the pure protein or peptide.
The downstream phase includes processes from the chromatography steps to the final formulation of drugs, including e. On the other hand, when used cka the downstream or drug formulation phases, raw materials have to adhere to Ph.
Therefore, even if chemically same or similar, the products used in the usa jobs government jobs login page six sigma-aldrich coa and downstream phases are different due to different certification and quality control processes.
Buffers, which may be organic or inorganic, are added to a solution to prevent a rapid change in acidity when acids or bases are added creating a sitma-aldrich that has little reaction when it meets other liquids. Notifying Party’s views 68 In light of the regulatory differences between raw materials used at sigma-alsrich earlier stages and at governmenh later stages of the manufacturing process described above, the Notifying Party submits that a distinction shall be made between non-compendial buffers, generally used in the earlier stages upstream of the biopharmaceutical process, and compendial usa jobs government jobs login page six sigma-aldrich coa, generally used in the later stages downstream of the biopharmaceutical process.
Mobs, as indicated above, pharmaceutical companies are legally obliged to use compendial grade buffers when they end up in the на этой странице drug formulation. Commission’s assessment 70 The market investigation broadly confirmed the Notifying Party’s view that regulatory requirements play a role and vary according to joobs usa jobs government jobs login page six sigma-aldrich coa of products in the pharmaceutical process, жмите сюда was not conclusive as to which steps specifically require compendial products and whether there is, at least, one-way demand-side substitutability.
For instance, one supplier stated: jobw other raw materials [which include buffers], to our knowledge, GMP is not required”,30 and another considering that “The other raw materials for biopharma production e. Customers also explained that the situation of regulatory requirements is unclear in relation to buffers. One customer indicated regarding biopharm ingredients such as buffers that, isa regulatory requirements, they “file as little as usa jobs government jobs login page six sigma-aldrich coa, while lkgin their internal requirements “no посмотреть больше rule uwa.
It could be Ph Sigma-alvrich, other compendia or just relevant parts governmenr these, internal requirements or a combination of these, depending on type of material and use. However, it does not lead to any affected market and, thus, these products will not be further discussed in the Decision. This illustrates a mutation in the pharmaceutical industry whereby responsibility on the quality and certification of raw materials for production is being shifted to usa jobs government jobs login page six sigma-aldrich coa supplier.
This evolution of customers’ requirements is also in line with the last guidelines published by the European Commission in relation to excipients, which clarify the risk management procedure to be carried out by the manufacturing authorization holder regarding whether the appropriate GMP have been applied. In this respect one competitor currently not active in this area explained that “the investment would be significant to produce these chemicals on our own and would include the building of new manufacturing facilities”.
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We are MSX International — a leading, global provider of technology-enabled business process outsourcing BPO services to automotive manufacturers. For more than 25 years, MSX International has worked closely with vehicle manufacturers around the world.
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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veteran status, age, or any other characteristic protected by law.
The Dartmouth Health Value Institute serves a central function within our organization to efficiently and effectively serve the quality and improvement needs system-wide, working collaboratively to support individuals and groups working on performance improvement projects across Dartmouth Health.
The Value Institute is a service group that responds to the requests and needs of Dartmouth Health collaboratively, with clear leadership and accountability on performance expectations. The Director serves as a key partner to the Chief Quality and Value Officer for Dartmouth Health, in the development, oversight, and execution of the quality strategic plan.
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Questions may be directed to: Mark L. Semiao hitchcock. All laws, rules, and regulations governing public and court administrative operations. Court practices and procedures. Legal terminology related to court operations. Techniques used to conduct legal research. Human Interaction: Requires the ability to function in a managerial capacity for a division or organizational unit; includes the ability to make decisions on procedural and technical levels.
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We focus on helping small and middle-market manufacturers improve their profitability, performance, and competitive advantage. Due to client demand and aggressive growth goals, we seek to add a new Lean Practitioner to our team. DVIRC works with clients in three key practice areas: consulting Solutions for business growth and operational excellence; customized on-site and public Training and Education; and Executive Network Group Memberships.
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Summary of Position: Lead the development, deployment, strategy, projects and teaching of Lean Six Sigma LSS mindset, philosophy and tools across the manufacturing site. This role will provide technical leadership and subject matter expertise to drive variability reduction, sustain process optimization and value delivery through the use of continuous improvement tools and Lean Six Sigma structured problem-solving methodology. The position is responsible for engaging team members across the manufacturing site to drive continuous improvement through focused problem solving of complex problems.