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A Successful and growing Global Medical Device-Pharmaceutical Industry Manufacturer has a unique opportunity for a  Corporate Lean Six Sigma Manager within the Corporate Process Excellence program. This role is a Strategic Individual Contributor leading and carrying out strategy for Lean and  Six Sigma High Priority Projects and Teams within the Process Excellence department and Cross-Functionally. The Lean Six Sigma Manager - manufacturing will focus on creating new and improved Lean processes ...

Streffco Consultants, Inc., is an international staffing and systems integration organization. We provide technology and business operations resources on a project, contract, contract-to-hire or direct hire basis. Title: Project Manager Job ID: 3970 Industry: Biotech/Pharmaceutical Location: Weston, MA (Moving to Cambridge, MA) Duration: 6 Month Contract Pay Rate Range: Depends on Experience (W-2 all inclusive rate) Job Summary: The Project Manager, reporting to the New Product Operations (NPO) ...

Job Summary: The Project Manager, reporting to the New Product Operations (NPO) Group, will be responsible for project leadership, commitment to program success, and building relationships with customers and key stakeholders, while meeting all cost, schedule and technical requirements of the program. The NPO is part of the Global Operations Group within PO&T (Pharmaceutical Operations and Technology). PO&T is the global manufacturing and supply chain organization. The Project Manager will perform ...

our client is looking for an associate scientist in cambridge, ma. this is a long term position. Job Description We are seeking motivated and creative individuals to join our Cell Line Development team through April 2013 and contribute to ongoing efforts to engineering superior host cell lines for the manufacturing of therapeutic proteins. The successful candidate will have mammalian cell culture/cell line development experience. Candidates with experience performing transfections, basic molecular ...

Seeking a seasoned scientific professional who is proficient with all facets of downstream protein manufacturing from pilot to production scale and who is ready to transition into hands on leadership role Requires 4+ years experience developing purification processes for proteins, enzymes, PEGylated proteins, antibodies, or peptides to be scaled up and transferred from development to clinical and commercial manufacturing. Join a company focused on the future. Offering extremely generous ...

Seeking experience developing methods for characterization of protein drug candidates, hands on development experience with Liquid chromatography - Mass Spectrometry, two dimensional Gel Electrophoresis, and track record contributing to BLA and IND filings to lead group of 4 scientists supporting process development and final product comparability evaluations for vaccine developer and manufacturer. World class vaccine development and manufacturing company offering an amazing opportunity to lead a ...

  Here at ProPharma Group, we work with clients in the pharmaceutical, biotechnology and medical device industries throughout the United States to provide the best solutions for their unique challenges and concerns. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes. Our goal is to provide the information our clients need to deliver safe, effective and quality products and services every time. ...

Responsibilities: • The person in this function will be responsible for developing purification processes for manufacturing novel viral vaccine candidates for toxicology studies and Phase I/II/III clinical trials. • Execute experiments in close collaboration with Research and Technology Development team to establish Phase I-III clinical manufacturing process • Perform activities in support of definition of bulk purification processes for novel viral vaccine candidates (virus/virus-like particles, ...

  Research & Development Project Manager   Summary The Research & Development Project Manager focuses on the development and launch of new, pre-cooked, center-of-the-plate entrée items including the actualization of desired flavor, texture and appearance profiles within the cost and quality constrains provided. Project and product involvement will extend from ideation through production-floor test runs and final production start-up acceptance and ongoing manufacturing operations.   Essential Duties ...

Seeking 3+ years experience developing topical dosage forms such as gels, creams, ointments, lotions, and novel delivery methods. Shall *** Conduct preformulation analysis physical and chemical characteristics of the drug and dispersed system including solubility, particle size distribution, surface area, polymorphism, surface tension, and rheology. *** Analyze stability and release by visual evaluation, pH, chromatography, particle size analysis, and in vitro diffusion *** Collaborate with ...

Sr. Complaint Specialist (3 Openings) 6-9 month W2 contracts, extendable Job Description: Responsible for receiving, reviewing processing, and analyzing all product inquiries and product complaints for client manufactured and distributed products (equipment, drug & device) as required by applicable regulations, standards and company policy.  Helps provide customer support and serves as a liaison between manufacturing facilities, distribution centers, customer/technical service and customers/patients ...

 My name is Myesha Oliver and I represent The Fountain Group.  We are a national staffing firm and are currently seeking Mgr Quality Assurance for a prominent client of ours.  This position is located in Lexington, MA. Details for the positions are as follows:   Job Duties: Job Description:   Primary Role: This individual will work in the Quality Assurance department as part of External US QA. This individual will provide QA support of expansion into global supply of commercial Diagnostic Kits, ...

The Surgical Sales Representative would be responsible for selling surgical products in accordance with budgeted objectives and to obtain maximum profitability and volume in relation to pre-set standards Responsibilities include: - Educate and inform doctors, nurses, and appropriate staff personnel as to the proper use and maintenance of company products - May direct product evaluations in OR and office settings - May assist in the preparation and operation of trade shows, conventions, and/or ...

Business/Product Analyst Cambridge, MA Long-term Contract [email removed] or 646.790.8355 This position will serve as a tactical IT liaison to the engineering or manufacturing or facilities (manufacturing is secondary to engineering) business units through maintaining a partnership. Must demonstrate an understanding of a GMP environment and its supporting technology as well as demonstrate business partnership and technology expertise. Other responsibilities include but are not limited to: •Project ...

Supply Chain Planner / Manager Biotech, Weston, MA Long-term Contract [email removed] | 646.790.8355 The Commercial Supply Chain Planner is a key member of the Global Operations team and is responsible for planning and coordinating product supply activities for the company's commercial products. This role requires monitoring of commercial inventory level and coordination across functions to maintain supplies at appropriate levels within the company and at external vendors. Specific responsibilities ...

Business Analyst – Product Engineer Long-term Contract Cambridge, MA [email removed] | 646.790.8355 This position will serve as a tactical IT liaison to the engineering or manufacturing or facilities (manufacturing is secondary to engineering) business units through maintaining a partnership. Must demonstrate an understanding of a GMP environment and its supporting technology as well as demonstrate business partnership and technology expertise. Other responsibilities include but are not limited to ...

  Quality Specialist FinPack Department: QA Office: Clinton, MA Location: Clinton, MA Description: Position Summary: Performs compliance activities in support of production departments. Areas of responsibilities may include review of documents such as batch records, charts and logs, data review, incoming sampling, incoming inspections, release testing and writing SOPs. The position will provide floor support to production departments to include line clearance, in-process checks, ...

  Position Summary:  Develops and implements validation and qualification policies, procedures and protocols.  Reviews and analyzes protocol data to determine if requirements are met.  Prepares and submits protocol reports for internal and customer review.  Recommends corrective action where necessary and develops master validation plans.  Assist with all activities for handling Finished Product from receiving to shipping as well as assessing and ensuring compliance through training, auditing ...

Shall collaborate with customers, engineers, scientists and supply chain to coordinate the development, setup, testing, upgrade, modifications, tech transfer, scaleup and delivery of custom assay kits for clinical studies. Oversee small volume manufacturing projects involving medical devices, reagents and other test kit components. Ideal candidate will be familiar with Project controls, docementation requirements and quality standards related to medical device or diagnostic reagent products. ...

Shall oversee small volume manufacturing projects involving medical devices, reagents and other test kit components used in Clinical Trials -- ideal candidate will be familiar with Project controls, docementation requirements and quality standards related to medical device or diagnostic reagent products. Requires 5+ years with Contract Manufacturing Organization or similar producing assay kits. Shall: *** Use Project management software for scheduling resources and activities for parallell ...

Seeking manufacturing experience with reagents and diagnostic test medical devices to oversee small run manufacturing projects. Must be familiar with: *** GMP *** FDA Regulations *** Ability to schedule multiple production runs for diverse products using common resources with peak efficiency. I.E. leanly. *** Cellular manufacturing techniques applying lean methodologies. *** Project management software for scheduling resources and activities. Products are used in Clinical Trials so ...

Lead team focused on the development, validation, and implementation of multi-modal assays that test for disparate target types, including miRNAs, single-nucleotide polymorphisms, gene expression biomarkers, and hybrid genes caused by translocation, interstitial deletion, or chromosomal inversion. Hands-on role in developing assays, validation, and managing the transfer to manufacturing. Highly visible director level position with a leader in the scientific community. Salary $100,000 to $140,000 ...

Seeking Ph.D. and experience managing Assay Development Groups identifying targets, and developing and validating new immunoassay products. Shall oversee: *** Antibody selection *** Assay development *** Transfer to manufacturing *** Documentation development. Required Experience: *** Recombinant Proteins. *** Antibody Development. *** Multiplexing. This company is poised for tremendous growth in the near future. This leadership opportunity comes with and incredible starting ...

Seeking 5+ years regulatory affairs experience with a diagnostics and-or medical device development and manufacturing company with a personal track record involving multiple successful submissions to the US, EU and Canadian regulatory agencies to: *** Provide strategic support to currently marketed products including; review of design and process changes, labeling, promotional materials and documentation for compliance and for changes requiring regulatory agency approval and notification. *** ...

Seeking Experience in the medical device manufacturing industry with a specific focus on regulatory compliance in the FDA Class I and II medical devices and track record successfully preparing documentation for 510(k) regulatory submissions and gaining approvals. Shall: *** Manage all Quality Assurance and Regulatory Affairs functions. *** Develop and implement global regulatory and compliance strategies. *** Instill a corporate culture of the development, maintenance and use of effective ...

  We are hiring a Sr. Compliance Specialist work onsite in the Boston area.   Education            Bachelor's Degree and 5 years Quality and/or Operations experience in a CGMP Manufacturing Environment or equivalent or 7 years experience in Quality and/or Operations experience in a CGMP Manufacturing Environment or equivalent Knowledge of CGMP regulations for US, EU and other markets Experienced with CGMP documentation review        This position is responsible for performing a ...

Position Specific Requirements: Supports manufacturing by performing balloon equipment changeovers in a timely and efficient manner. Supports research, product development, and manufacturing efforts for the Endovascular department. Responsible for the setup, operation and changeover of balloon forming equipment to meet production demands. Assists Manufacturing Engineering in the troubleshooting of balloon forming equipment and processes as needed. Assists with the qualification/validation of test ...