Date Posted:

11/8/2008

 

Job ID:

1664

 

Company:

We are a research-driven pharmaceutical company. We have a long history of ground-breaking developments in pharmaceuticals and biotechnology. We lead the world in the discovery and development, manufacturing and marketing of vaccines and pharmaceuticals. We improve the lives of millions of people around the world with our exceptional products. And new, innovative medicines are on the way. We bring products to the people who need them around the world.

 

Location:

Upstate New York

 

Reports To:

Sr. Director, Toxicology

 

Salary:

120s to mid 130s + bonus, stock and stock options

 

Education:

PhD in TOXICOLOGY, Pathology, Pharmacology, or related field required. Board certification preferred.

 

Requirements:

8 - 10 years experience required in an industrial/pharmaceutical environment, including extensive TOXICOLOGY/Drug Safety Evaluation experience. A minimum of 10 years of management experience required along with strong communication, project management and leadership skills. Training in GLP standards and Drug Safety Standard Operating Procedures, and domestic and foreign regulations and standards, and new drug applications is required.

 

Duties:

Job Summary: Responsible for leading the TOXICOLOGY functions in evaluating the non-clinical safety of drug substances for both US and International product registration and managing Drug Safety and Metabolism projects. This includes developing regulatory strategy (e.g. protocol development) to support product registration worldwide and assuring that the TOXICOLOGY studies are conducted at a high level of quality and in conformance with Company and regulatory standards. In addition, this position will be responsible for a dedicated therapeutic area to select and manage the best product candidates from Discovery Research through full development. Manages the project related technical/scientific activities of the Technical Resources/Study Toxicologists, and Discovery Interface areas. Assures regulatory compliance at all levels of operations in TOXICOLOGY. Assures that all work is designed and prepared to meet all internal and external standards of quality. Meets with all regulatory functions (FDA, as well as international regulatory bodies) representing the TOXICOLOGY Department and Company in support of product registration in the US and Internationally. Directs selected Drug Safety and Metabolism Teams and develops regulatory strategies, including protocol development and data interpretation, to support product registration on global basis. Coordinates activities across DSM line functions, Project Management, Discovery, Chemical and Pharmaceutical Development, and Clinical R&D throughout the development process. Should be responsible for preparation of Quality Global Regulatory Submissions. Recommends priorities for the allocation of resources (manpower, equipment, animals, etc.): uses creative and innovative approaches to develop and modify new or existing technologies and procedures. Assists the Sr. Director, TOXICOLOGY in the final review and acceptance of drug study and evaluation reports. Assures that the scientific interpretation of data and results is accurately and appropriately performed, and that the integration of TOXICOLOGY and pathology results occurs. At the request of the Sr. Director, TOXICOLOGY, handles special projects and/or assignments. Participates as a committee member, when needed, on Task Forces and/or Committees. Acts as backup for the Sr. Director, Pathology/Bioresources, in his absence. Maintains associations with scientific and professional organizations to keep abreast of technical developments in drug safety and TOXICOLOGY.

 

Date Posted:

10/23/2008

 

Job ID:

1662

 

Company:

We are a worldwide specific pharmaceutical and medicine delivery/medical device company devoted to improving health by developing, manufacturing and marketing products that help improve the productivity, protection and effectiveness of patient care. We recently acquired another Pharma company to become the global leader in special injectable pharmaceuticals that happen to be generic. With over 7 decades of service to the hospital industry, Our portfolio includes one of the industry's extensive lines of injectables, solutions for medicine management. As well as infusion therapy. We are also a primary provider of contract manufacturing services to proprietary pharmaceutical and biotechnology companies. Our extensive portfolio of products is used by hospitals and other site providers, such as clinics, home health care providers and long-term care facilities.

 

Location:

Illinois

 

Reports To:

Director Product Development

 

Salary:

$99K – 110K depending on experience.

 

Education:

Phd.

 

Requirements:

6 years experience in pharmaceutical industry with development of natural-sourced biological or biotechnology-derived products. Must be proficient in the analysis and characterization of carbohydrates and proteins and understand the impact of manufacturing processes on the products. Should be familiar with IND, NDA, and BLA submission requirements with knowledge of GMP and GLP guidelines. Must have excellent verbal and written communication skills, be able to work in cross-functional teams, and maintain project schedules on multiple programs.

 

Duties:

The Sr. Group Leader provides technical leadership for their direct staff in the development of complex protein and carbohydrate products. The primary responsibilities are focused on the analytical chemistry, manufacturing process, and formulation development activities. They include the assessment of technical challenges for new programs, preparation of detailed development plans, and leading their staff to meet the projects development goals. The Sr. Group Leader serves on the core program team, maintains effective cross-functional communication, and coordinates activities with other functional areas.

 

Date Posted:

10/21/2008

 

Job ID:

1658

 

Company:

We are an eye care company. We are committed to making vision perfect and improving the lives of consumers around the world. We offer the world’s most complete collection of eye care products. Our healthcare brand is one of the best known and most valued worldwide. Our products are available in more than 100 countries. We continue to invent new materials, engineer new technologies, and create ground-breaking ways to help people see better.

 

Location:

Upstate New York

 

Reports To:

Director of Toxicology

 

Salary:

$92K- $115K Bonus 15%

 

Education:

Ph.D. in Toxicology or related field.

 

Requirements:

Minimum of 4 years experience in Medical Device Toxicology. Strong working knowledge of regulations and requirements for safety assessment and experience in managing non-clinical safety studies.

 

Duties:

Overseeing the planning, strategy, development, and execution of the Non-clinical Safety programs supporting company, and other areas as needed; prepare and defend regulatory documents; provide guidance and risk assessments on new formulations, leachable/extractables, industrial hygiene, workplace safety, and environmental issues; and (iv) manage studies at external contract facilities. Represent the Non-clinical Safety function on project teams. Design strategies, execute and manage Non-clinical Safety programs focused on our products. Conduct risk assessments on key ingredients, impurities, and formulations. Publish novel investigative findings in high-quality journals and present data at scientific national meetings. Oversee and evaluate activities of contract research organizations performing toxicology studies.

 

Date Posted:

10/8/2008

 

Job ID:

1657

 

Company:

Our company produces and distributes a wide variety of blood flow measurement devices for surgery, dialysis and medical research, and offers entrenched flow measurement resolutions to producers of medical devices. Our equipment is used in medical centers and hospitals globally to give instant, quantitative flow results during cardiac, transplant, peripheral vascular and cerebrovascular surgeries.

 

Location:

Upstate New York

 

Reports To:

Director Engineering

 

Salary:

65K

 

Education:

BS degree in Engineering.

 

Requirements:

3 years exp., ASQ or CQE preferred.

 

Duties:

Prepares ISO compliant documentation and provides training support, participates in new product design reviews, champions corrective action process relative to internal and external product/customer complaints, designs /conducts experiments for root cause determination, generates vendor corrective actions and follow up, develops testing to assure compliance to all internal and customer regulatory specs and develops supplier quality improvement initiatives.

 

Date Posted:

8/14/2008

 

Job ID:

1638

 

Company:

We are a Dental company creating state of the art 3D imaging technology with the capacity to provide precise models of a patient’s teeth by taking an intra oral optical impression. Our technology will do away with the conventional messy and distasteful impression process now being used and is poised to transform restorative dentistry.

 

Location:

CA

 

Reports To:

CEO

 

Salary:

$110K to $130K depending on experience

 

Education:

BA or MS degree in Computer Science, mathematics, physics, engineering or related field.

 

Requirements:

The ideal candidate will be multidisciplined in the areas of software engineering, robotics engineering, and vision systems and have 5+ years of product development in the medical or laboratory device field. Technical training or experience in robotics and optical instrument development methods and techniques preferred. Requires 3+ years hands on experience with Microsoft Visual Studios C++ version 2005 used to develop system level applications for machine or instrument control in a Windows XP environment. Experience with Matlab, 2D and 3D graphics tools, Open CV and a strong image processing background is desired. Must be hands on and detail oriented with good mathematical and analytical ability and a proven track record of developing and releasing software for commercial products. The ideal candidate will be a highly self-motivated individual with a high degree of creativity and the ability to focus on complex tasks and drive them to completion.Experience with relevant regulatory requirements for a medical device is a plus.

 

Duties:

Job Summary: Hands-on, leadership role in the development and integration of medical device quality software with systems involving robotics, computer vision, and complex 3D modeling of surfaces. Current experience with, and strong competency in, development of Windows XP based applications using MS Visual Studios 2005 is essential. Responsibilities: Plan, design, write, and test software and algorithms developed for the Companies FastScan intra oral dental impression system. Collaborate with engineering staff , marketing, and dental professionals in the design, development, deployment, and maintenance of software applications. Contribute to the Software Engineering effort on a high-level in cross-functional project teams that identify project specifications, develop system architectures, allocate requirements and carry out the necessary effort. May interface with manufacturing in the transition of assigned projects. Troubleshoot the most challenging problems and, in collaboration with other members of the software team, recommend and implement solutions. May directly supervisor or indirectly guide and mentor other software engineers.

 

Date Posted:

7/2/2008

 

Job ID:

1632

 

Company:

We are a primary provider of software, calculated consulting, and regulatory services for performing clinical pharmacology development. Our database Server for the storage, management, analysis, and regulatory reporting of derivative data and models in data repositories for efficient on-site validation; and Drug Model for vibrant visualization and communication of sample-based product profiles. Our company develops and markets integrated products and services that allow pharmaceutical and biotechnology companies to attain major and lasting improvements in the development and use of therapeutic products. Company strives to help customers reduce the time, cost and risk of drug development. We enhance drug development decision-making and efficiency through our services.

 

Location:

North Carolina

 

Reports To:

CEO

 

Salary:

180-225k

 

Education:

Advanced degree in Computer Science/Engineering/Mathematics or other related technical field.

 

Requirements:

A minimum of 10 years of senior technology management experience developing and deploying complex software products to Fortune 2000 companies, including recent experience leading a 30+ person organization. A proven track record of delivering world-class, large-scale, performance critical multimillion-dollar software product projects on time, on budget and with quality to external clients. Significant and proven experience in operational excellence with a thorough understanding of software development organizational processes including architecture, iterative development, program management, user-centered design and testing automation. First-hand experience with the latest software engineering productivity, quality, and cost control methodologies with a proven track record of delivering quality products within defined time constraints and within budget. Deep understanding of agile methods and software engineering development cycle. Sound knowledge in Unix (server) and Windows (server and desktop) development, web application/services development & deployment, object-oriented system architecture and APIs, C++, .NET, Javascript, SQL. Familiarity with reporting requirements for clinical/pre-clinical pharmacology, DMPK, or clinical/pre-clinical pharmacokinetics departments a plus. Experience with technical and/or scientific applications a plus. Capable of managing and motivating an entrepreneurial, high-energy, high-quality, high-output software development organization. Proven leadership and mentoring skills with the ability to work effectively with executive management. Have a passion for developing within the team a strong understanding of customer needs and establishment of operational standards necessary to meet and exceed those needs. Ability to present complex technical information in a clear and concise manner to a variety of audiences, including non-technical. Experience and comfort operating in a dynamic environment where requirements might shift to meet changing business needs. Ability to align best business practices with companys mission and values. Superior organizational and planning skills with excellent written and verbal presentation skills. Travel Required: 5-10%. # Employees Supervised: Team of approx. 30 with 6 direct reports.

 

Duties:

The VP of R&D will be responsible for leading the design, development, quality engineering, quality assurance and technical publications functions of the engineering organization. As a key member of the business unit management team, the executive must provide the leadership and direction necessary to maintain the focus and drive of an exceptionally bright and technically diverse engineering team. The VP of R&D will focus on transitioning engineering into a world-class execution team and will apply deep technical and organizational understanding to making tough decisions and ensure accountability for all deliverables. The VP of R&D will be a proven expert in the field and will be responsible for developing and implementing the strategy for software development processes, tools and metrics for the group. The executive will participate in strategy, planning and technical meetings with business leaders and will provide strong leadership in the technical portion of that strategy. The organization will also look to the VP of R&D to identify best practices and to institute a program of continual process improvement. The VP of Engineering will be a hands-on leader with a passion for building compelling customer experiences and a proven ability to grow and lead a team of talented engineers and managers through design, development, testing and launch of cutting-edge software products. One of the primary measures of the successful candidates performance, in addition to meeting or exceeding the groups commercial goals, will be the ability to mold diverse development groups into a seamless team with a common goal and vision. Essential Job Functions: Direct all aspects of the company’s software development efforts to ensure that product development, testing and ongoing maintenance milestones are accomplished with success in schedule adherence, budget compliance and product quality. Ensure a credible implementation plan is in place when the product release content is approved by the executive team. Provide leadership in the review of existing technology and solutions and determine appropriate strategy for technology and architecture. Energize the organization to maintain continuous improvement programs and explore creative ideas on significantly improving performance. Work closely with Product Management to guide the functional and technical direction of our core products and to provide strong leadership for the technical portion of that strategy. Implement organizational procedures that support product development. Work with executive management to understand business drivers, marketing requirements and competitive issues that may impact departmental strategies. Mentor high-potential managers to assume greater future responsibilities.

 

Date Posted:

6/16/2008

 

Job ID:

1626

 

Company:

We are a worldwide specific pharmaceutical and medicine delivery/medical device company devoted to improving health by developing, manufacturing and marketing products that help improve the productivity, protection and effectiveness of patient care. We recently acquired another Pharma company to become the global leader in special injectable pharmaceuticals that happen to be generic. With over 7 decades of service to the hospital industry, Our portfolio includes one of the industry's extensive lines of injectables, solutions for medicine management. As well as infusion therapy. We are also a primary provider of contract manufacturing services to proprietary pharmaceutical and biotechnology companies. Our extensive portfolio of products is used by hospitals and other site providers, such as clinics, home health care providers and long-term care facilities.

 

Location:

Illinois

 

Reports To:

Director – Advanced Technology Center

 

Salary:

100-150K

 

Education:

Phd

 

Requirements:

Start up mentality. Knowledge of many disciplines. Prototyping exp.

 

Duties:

 

Date Posted:

5/20/2008

 

Job ID:

1619

 

Company:

We are a worldwide specific pharmaceutical and medicine delivery/medical device company devoted to improving health by developing, manufacturing and marketing products that help improve the productivity, protection and effectiveness of patient care. We recently acquired another Pharma company to become the global leader in special injectable pharmaceuticals that happen to be generic. With over 7 decades of service to the hospital industry, Our portfolio includes one of the industry's extensive lines of injectables, solutions for medicine management. As well as infusion therapy. We are also a primary provider of contract manufacturing services to proprietary pharmaceutical and biotechnology companies. Our extensive portfolio of products is used by hospitals and other site providers, such as clinics, home health care providers and long-term care facilities.

 

Location:

Illinois

 

Reports To:

VP, Pharmaceutical R&D

 

Salary:

175k or Commensurate with experience

 

Education:

Ph.D., DVM or M.D. And Board Certification in Toxicology

 

Requirements:

Minimum of 15 years experience in the drug development and drug discovery industry. Doctoral required + 7-10 years of relevant outstanding experience to effectively manage/direct product development teams and all related activities with respect to science, technology, quality, regulatory and compliance requirements. Advanced degree in an appropriate scientific field that is directly applicable to preclinical safety (including, but not limited to, toxicology or pathology).

 

Duties:

PRIMARY FUNCTION: The Director of Pre-Clinical Development provides expertise and consultation for multiple drug and drug device candidates through all phases of preclinical and clinical development. Serves as a key member of the Specialty Products R/D Team to ensure that Preclinical Safety strategy is aligned closely with clinical/regulatory/quality development strategy. The Director of Pre-clinical Development facilitates the development and maintenance of company products by assessing their safety through evaluation and interpretation of their effects on in vivo and in vitro experimental systems and safety literature. Preclinical Development ensures the proper design, conduct, interpretation, and timely reporting of studies that are critical for successful Investigational New Drug Applications, New Drug Applications, abbreviated New Drug Applications, and 510K Submissions, and registrations in foreign countries, both prior to and concurrent with clinical studies in humans. It also functions to prepare toxicology and associated sections of such submissions and assesses new product opportunities for safety. The Director of Preclinical Development will supervise and manage up to 5 subordinates. Incumbent has responsibility for staffing, work flow scheduling and staff development. MAJOR DUTIES AND RESPONSIBILITIES: 1. Plans- Through interactions with appropriate Specialty Products, Regulatory, Clinical and Quality personnel, recommends and takes an active role in the planning of safety studies. He may contract work from other functions such as pathology, kinetics, metabolism, drug analysis to ensure optimal compound evaluation. 2. Conducts- Anticipates, recognizes and resolves scientific and technical problems that are encountered during various phases of drug drug/device evaluation. Monitors timelines and cost. Conducts broad literature reviews. 3. Interprets Data - Understands, draws own conclusions, and/or critically evaluates data from multiple disciplines. Integrates data across disciplines to draw new or extended conclusions. Defines alternative scenarios for aspects/parts of larger problems. 4. Communication - Provides complex communications under tight deadlines. Can communicate relevant facts clearly and concisely. Serves as facilitator to ensure that appropriate individuals are involved in key decision making and interpretive efforts. Develops and/or participates in presentations in an internal and external venue, to include US and international regulatory agencies. 5. Leadership- Serves as a central person for direction of Company product development and disposition. Is most often the contact person for Preclinical Safety when in-licensing compounds are to be evaluated. Empowers and delegates effectively.