MindPharm Blog

Senior R&D Scientist

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MindPharm is partnering with a growing developer and manufacturer of rapid detection technologies. The company is developing a novel biosensor technology which allows for extremely rapid detection of bacteria, viruses, and protein targets at previously unseen levels of sensitivity and specificity. With facilities in Rockville, MD the following position will have the opportunity to lead the ongoing investigations for the development of long term stability and assay preservation.

Location:

Rockville, MD

Reporting to:

Vice President of Research

Technology Description:

The patented biosensor system is capable of generating a result in less than five minutes, making it one of the most rapid methods available. In addition, biosensors can be engineered to detect one target or several targets of interest simultaneously and used to perform a wide variety of bioassays. Designed for portable, real-time detection, minimally skilled personnel can perform tests at the site of sampling using small, transportable instrumentation.

The company has obtained exclusive rights to the technology in several fields and focuses on applications requiring a high degree of speed, portability, and sensitivity in testing capabilities. The company's technology is expected to have broad applications in food testing, animal health and human health care.

Position Description:

The R&D Scientist will work extensively in cell / molecular biology to create new cell based assays for the detection of bacterial organisms. This role will span the spectrum from research to technical support and draw upon a broad skill set to span early research through full range of product conceptualization, development and optimization.

Responsibilities

• Develop products

• Create new cell based assays

• Sample preparation (collect, break down, minimize inhibitory factors, etc.)

• Initial evaluation of biosensor

• Assay optimization (Experimental design)

Educational Background

PhD in Molecular / Cell Biology and 3+ years of experience

- or -

MS in Molecular / Cell Biology and 5+ years of experience

Qualifications

• Immunology based assays

• Microbiology / bacteria

• Cell biology

• Molecular Biology

Competencies:

• Conceptual thinker

• Trouble shooter / problem solver

• Ability to implement programs with minimal direction

• Lab / bench based person

• Can work independently

• Comfortable and experienced working with bacteria

• Commercial experience working with customers

Technical skills:

• Mammalian cell culture

• Molecular cloning techniques

• PCR

• Engineering of stable mammalian cells

• Assay development and optimization

• Antibody-based assays (ELISA, western blotting)

• Basic microbiological techniques

• Strong problem solving / Trouble shooting skills

For consideration please contact: stephanie.miller@mindpharm.net

Biosensor Development Scientist

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MindPharm is partnering with a growing developer and manufacturer of rapid detection technologies. The company is developing a novel biosensor technology which allows for extremely rapid detection of bacteria, viruses, and protein targets at previously unseen levels of sensitivity and specificity. With facilities in Rockville, MD the following position will have the opportunity to lead the ongoing investigations for the development of long term stability and assay preservation.

Location:

Rockville, MD

Reporting to:

Vice President of Research

Technology Description:

The patented biosensor system is capable of generating a result in less than five minutes, making it one of the most rapid methods available. In addition, biosensors can be engineered to detect one target or several targets of interest simultaneously and used to perform a wide variety of bioassays. Designed for portable, real-time detection, minimally skilled personnel can perform tests at the site of sampling using small, transportable instrumentation.

The company has obtained exclusive rights to the technology in several fields and focuses on applications requiring a high degree of speed, portability, and sensitivity in testing capabilities. The company's technology is expected to have broad applications in food testing, animal health and human health care.

Position Description:

The Scientist will be responsible for the development and application of new methods for enhancing the stability of the proprietary B cell reagent, with the goal of providing prolonged stability (months to years) at ambient or refrigerated temperatures.

• Work closely with the R&D team and industry subject matter experts to develop and apply new methods for B cell preservation

• Work closely with consultants/collaborators involved in B cell preservation efforts

• Characterize effects of preservation and storage on functional properties of proprietary B cells

• Work with Manufacturing team to integrate new methods into the manufacturing process

Position Responsibilities:

The responsibilities of the Scientist will include, but are not limited to:

• Integrate and develop new methods for B cell preservation to provide long-term stability at refrigerated/ambient temperatures

• Culture and manipulation of proprietary B cells

• Identification of methods for B cell stabilization through survey of published literature and discussion with subject matter experts

• Interacting with and supporting collaborators to facilitate progress

• Applying new methods to validate their utility

• Optimizing preservation methods

• Identifying new opportunities for applying the technology to meet market opportunities.

• Working as part of a scientific team

• Providing technical presentations at trade shows

• Writing grant applications

• Keeping abreast of competing technologies in the public and private sectors

• Identifying and sharing market-sensitive information and intelligence to the management team, and suggesting new strategies where appropriate.

Background and Experience:

• PhD in life sciences with experience in cell biology and molecular biology ( >3 years of experience)

• Solid understanding of principles of mammalian cell biology

• Experience with high-temperature long-term stabilization of mammalian cells is a plus

• Working knowledge of microbiology and immunology mechanisms

• Familiarity with Design Control, in vitro diagnostics or product development is a plus

• Strong verbal and written skills

• Effective presenting technical information to large groups

Technical skills:

• Mammalian cell culture

• Molecular cloning techniques

• PCR

• Engineering of stable mammalian cells

• Assay development and optimization

• Antibody-based assays (ELISA, western blotting)

• Basic microbiological techniques

• Strong problem solving / Trouble shooting skills

For consideration please contact: stephanie.miller@mindpharm.net

Biosensor Process Engineer

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MindPharm is partnering with a growing developer and manufacturer of rapid detection technologies. The company is developing a novel biosensor technology which allows for extremely rapid detection of bacteria, viruses, and protein targets at previously unseen levels of sensitivity and specificity. With facilities in Rockville, MD the following position will have the opportunity to lead the ongoing efforts to expand and improve manufacturing technology for this innovative assay platform.

Location:

Rockville, MD

Reporting to:

Vice President of Research

Technology Description:

The patented biosensor system is capable of generating a result in less than five minutes, making it one of the most rapid methods available. In addition, biosensors can be engineered to detect one target or several targets of interest simultaneously and used to perform a wide variety of bioassays. Designed for portable, real-time detection, minimally skilled personnel can perform tests at the site of sampling using small, transportable instrumentation.

The company has obtained exclusive rights to the technology in several fields and focuses on applications requiring a high degree of speed, portability, and sensitivity in testing capabilities. The company's technology is expected to have broad applications in food testing, animal health and human health care.

THE POSITION

The company launched their proprietary air testing applications in late 2007 and are in the process of scaling up cartridge manufacturing capacity. We are looking for a smart, innovative, hard working engineer to expand manufacturing capabilities. (This role will span a spectrum from supply chain, manufacturing process improvement, product assembly, quality control, process improvement, staffing, training and technical support). Initially this position will be very hands-on. As volumes grow the process engineer will help to build the organization and systems required to meet customer requirements.

Responsibilities

• Design and implementation of manufacturing processes, instrumentation and equipment for manufacturing scale-up. Provides expertise in equipment engineering, design and process scale-up. Establishes equipment specifications and manufacturing process improvement programs. Involved in new product scale-up, process optimization, technology transfer and process validation activities. (96101)

• Develops and maintains quality standards for processing materials into finished products. Designs and implements methods and procedures for inspecting and testing products. (93121)

• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements (audits, training and documentation reviews, writes SOP?s / QC procedures) (93001)

• Evaluates and implements protocols / methods to inspect and test, in-process materials and finished goods. Performs analysis and identifies trends in the inspection of in-process and finished products. Implements corrective action when necessary (92121)

• Collects data, performs analysis and identifies trends in inspection and finished products

• Recommends and implements corrective action to address process or customer concerns

Educational Background

BS / MS - Biomedical / Chemical / Mechanical Engineering with 4 ? 5 years of experience.

Qualifications

Lean / Six Sigma

Manufacturing experience (preferably in the life science industry)

Previous military experience is a plus

The ability to work well in a team environment

Strong oral, written and presentation skills

Working knowledge of ISO

Trouble shooting skills

Works independently

Deals effectively with ambiguity

For consideration please contact: stephanie.miller@mindpharm.net

The cell preparation is expensive, but still less than long-term costs of treating symptoms with prescription drugs. Further, the technique may generalize to other auto-immune diseases.



BBC NEWS | Health | Hope for arthritis vaccine 'cure'

A sample of the body's white blood cells is taken and treated with a cocktail of steroids and vitamins which transforms a particular type of immune cell called a dendritic cell into a "tolerant" state.

These cells are then injected back into the joint of the patient.

Director, Clinical Regulatory Affairs

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MindPharm is partnering with a rapidly growing Pharmaceutical company focused on drug development for chronic pain. With facilities in Central New Jersey the following position will have the opportunity to build and lead a team of dedicated Regulatory Associates to support the company's clinical issues and regulatory strategy.

Location: Central New Jersey

Reports to: Director Regulatory Affairs

BASIC FUNCTION

The Associate Director acts as the initial regulatory resource for clinical development activities on assigned projects, providing functional area leadership to the team and managing the project activities of other regulatory staff assigned to projects under their authority.

JOB RESPONSIBILITIES

• Serves as the primary Regulatory Affairs representative to assigned clinical development teams(s) and interacts with other departments and with personnel from corporate partners

• Responsible for organizing regulatory submission teams and coordinating the editing and preparation of clinical module or clinical content of regulatory submissions, (e.g., INDs, NDAs, annual reports, IND amendments, NDA supplements, routine correspondence)

• Coordinates preparation of clinical information and related activities for meetings with drug regulatory agencies

• Participates in development of overall project goals and in particular those that pertain to clinical regulatory affairs

• Participates in regulatory strategy and position papers for clinical development candidates, submissions, drug regulatory agency meetings and special regulatory issues

• Participates in development of departmental methods and procedures and management of other regulatory staff

REQUIRED SKILLS

• 7+ years of related experience with at least 4-5 years of Regulatory Affairs clinical experience with increasing responsibility

• GCP and Clinical/CRO research knowledge and specifically regulations associated with INDs

• Leadership and managerial experience required

• Experienced in support of teams responsible for the preparation, and submission of INDs, CTAs and amendments, annual reports, and clinical and periodic safety reports

• Experienced in the process of interacting with regulatory authorities

• Editorial skills and ability; experience developing and managing technical processes and procedures

For consideration please contact: stephanie.miller@mindpharm.net

Director, Promotional Regulatory Affairs

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MindPharm is partnering with a rapidly growing Pharmaceutical company focused on drug development for chronic pain. With facilities in Central New Jersey the following position will have the opportunity contribute to the Regulatory Affairs Team.

Location: Central New Jersey

Reports to: Director of Regulatory Affairs

Position Description:

Manages all promotional regulatory activities for assigned projects, including representation on the project development teams as appropriate.

• In support of DDMAC activities, the individual will:

1. review, recommend, and approve drug product advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading.

2. provide clear and unambiguous communication of the laws and regulations relating to prescription drug promotion to our internal groups in support of their activities or functions for example: MLR, MSLs, SciCom, public relations (external presentations and press releases), scientific publications, and sales training (materials and tools).

• Supports regulatory review and approval of advertising and promotion materials and sales training materials for company?s marketed products.

• Assists in the corresponding regulatory submissions to DDMAC.

• Plans, implements and supports various strategic initiatives to improve company?s promotional regulatory compliance

• Collaborates with the Brand team during development of marketing campaigns for new products/new indications

• Serves as the primary regulatory liaison to the Marketing Services group

Responsibilities:

• Travel to major medical meetings and pharmaceutical conventions to monitor promotional exhibits and activities sponsored by the company.

• Monitors Drug Marketing Advertising and Communications (DDMAC) activities and actions

• Assesses impact of DDMAC actions, regulations and communicates that information on an on-going, basis to Marketing, Sales and Pharmaceutical Development Center Personnel

• Provides training to regulatory affairs personnel

• Provides evaluations, recommendations, and support to WW Regulatory Affairs Director/Sr Director

• Ensure compliance with all applicable guidances, regulations and laws.

• Participates and represents Regulatory Affairs in meetings and interacting with members of all development or life cycle management project teams to convey promotional regulatory requirements and develop a strategy to meet divisional goals.

• Communicate regulatory issues to functional areas and transmit regulatory concerns from functional areas to WW Regulatory Affairs management.

• Assists in the establishment and maintenance of Regulatory Affairs operating procedures for the department.

• Actively pursue the improvement of regulatory knowledge by studying the US Code of Federal Regulations and guidance documents as published by FDA, EMEA, ICH guidance as well as those generated by ex-US regulatory agencies (e.g., MHW).

Requirements:

• 8-10 years experience in Regulatory Compliance of Promotional and Advertising Materials in US, with 5+ years in a management role.

• Knowledge of advertising and promotion regulations, guidelines, agency regulatory action history and product labeling requirements.

Other Skills/Abilities

• Self-motivated and highly flexible individual who is able to manage multiple tasks and priorities within a fast-paced environment.

• Demonstrated ability to manage, mentor and train subordinates and manage outside contractors.

• Must have strong strategic and critical thinking, diplomacy, negotiation and excellent oral and written communication skills.

• Project management skills and experience.

• Editorial skills and ability; experience developing and managing technical processes and procedures.

• Excellent presentation skills including ability to tailor information and delivery to audience; present in various formats and delivery methods.

For consideration please contact: stephanie.miller@mindpharm.net

Researchers at North Carolina State University have discovered that
adding tiny bits of gold to a failed HIV drug rekindle the drug's
ability to stop the virus from invading the body?s immune system.

Failed HIV drug gets second chance with addition of gold nanoparticles

The drug, a compound known as TAK-779, was originally found to bind to a specific location on human T-cells, which blocks the HIV virus? entry to the body?s immune system. Unfortunately, the portion of the drug?s molecule that made binding possible had unpleasant side effects.

UK cancer researchers describe a unique protein tag on dendritic cells that can be used in a vaccine therapy in the Journal of Clinical Investigation.



Scientists find new cancer vaccine target - London News

"We have now found a tag on dendritic cells ? called DNGR-1 ? which can be targeted by vaccines.

"Vaccines will carry a sample of the offending molecule and deliver it to DNGR-1 on the dendritic cells. The dendritic cell in turn will present the molecule to the armies of T cells and instruct them to attack."

Alligator blood may put the bite on antibiotic-resistant infections


In collaboration with Kermit Murray and Lancia Darville, both of Louisiana State University in Baton Rouge, Merchant and colleagues collected blood samples from American alligators. They then isolated disease-fighting white blood cells (leucocytes) and extracted the active proteins from those cells. In laboratory tests, tiny amounts of these protein extracts killed a wide range of bacteria, including MRSA (methicillin-resistant Staphylococcus aureus), the deadly bacteria that are moving out of health care settings and into the community. These ?superbugs? are increasingly resistant to multiple antibiotics and cause thousands of deaths each year. The proteins also killed six out of eight different strains of Candida albicans, the researchers say. Their previous research also suggests that blood proteins may help fight HIV, the virus that causes AIDS.

ASQ's BioMedical Division will be presenting a two-day conference entitled "Regulators and Regulations - Who's being protected and how?"  from March 27 to March 28, 2008 at the Hilton Old Town Alexandria, Alexandria, VA. For more information follow this link to the ASQ website, http://tinyurl.com/ystpvy

The study reduced tumor necrosis factor (TNF) by injecting a theraputic called etanercept. 

Reversal Of Alzheimer's Symptoms Within Minutes In Human Study

An extraordinary new scientific study, which for the first time documents marked improvement in Alzheimer?s disease within minutes of administration of a therapeutic molecule, has just been published in the Journal of Neuroinflammation.

Mice were given high fat diets to induce weight gain, then given (Pro3)GIP. 

Human hormone blocker found to help prevent obesity and diabetes: study

This study showed that blocking GIP activity using (Pro3)GIP in mice with established, high fat diet-induced obesity and diabetes results in significant weight loss, improvement of insulin resistance and amelioration of diabetes. These findings represent an interesting new approach to the treatment of obesity and metabolic disturbances.





According to the research team¡¦s Nigel Irwin, Ph.D., "Interestingly, possible parallels exist with the benefits of Roux-en-Y surgery (gastric bypass surgery) in treating gross obesity and associated diabetes in people. In this procedure, nutrients surgically bypass the area of the small intestine, resulting in a deficiency of circulating GIP. We are looking to better understand how and why."

Mice have for the first time been cured of a severe blood disorder


similar to sickle cell in humans through treatment with stem cells created from tissue taken from their


own tails.

Sickle-cell mice cured with their own cells - health - 06 December 2007 - New Scientist

In the treated mice, most of these symptoms were reversed within a week or so. "All improved to almost normal," says Rudolf Jaenisch, head of the research team at the Whitehead Institute for Biomedical Research in Cambridge, Massachusetts, US. "These mice are basically cured."

Cancer-resistant mouse discovered

A mouse resistant to cancer, even highly-aggressive types, has been created by researchers at the University of Kentucky. The breakthrough stems from a discovery by UK College of Medicine professor of radiation medicine Vivek Rangnekar and a team of researchers who found a tumor-suppressor gene called "Par-4" in the prostate.

Living the Scientific Life (Scientist, Interrupted): Bone Hormone Linked to Obesity and Type 2 Diabetes

...exciting new research has shown that bones also act as an endocrine organ. Not only do bones produce a protein hormone, osteocalcin (pictured), that regulates bone formation, but this hormone also protects against obesity and glucose intolerance by increasing proliferation of pancreatic beta cells and their subsequent secretion of insulin. Osteocalcin was also found to increase the body's sensitivity to insulin and as well as reducing its fat stores.