FierceBiotech Jobs

[Full-time] Parasitology Assistant Supervisor (night shift) at Opus Scientific

2012-02-13 15:53:24

Location: New Hyde Park, NY
URL: http://www.opusscientific.com

Description:

Opus Scientific has an opportunity on the night shift for an Assistant Supervisor in the Parasitology Department of a large and well established company.

Responsibilities:

Maintain knowledge of department SOPs

Resolve problems through interaction with clients and service representatives.

Perform all routine testing and analyses of client specimens within department

Monitor workflow to ensure client turnaround times are met

Ensure that all logs are recorded according to laboratory standards

Monitor, analyze, review and sign all department quality control (QC) documentation

Ensure equipment is maintained and calibrated

Maintain and monitor service of instruments used in department

Maintain supply of reagents and consumables needed by department

Investigate complaints and incidents within department

Writing performance reviews of department staff

Responsible for scheduling department staff

Assist in development and management of financial budget requirements

Provide business review information to Lab Manager

Assist in personnel management including recruiting, hiring, training, disciplinary/corrective action, terminations and overall performance management

Understand, follow, and enforce laboratory safety and quality control procedures

Other duties and responsibilities as assigned

Qualifications:

BS Medical Technology or Microbiology

Two years of general clinical laboratory management experience.

Experience in diagnosis and epidemiology of parasites of veterinary importance.

Excellent communication skills

Ability to take the initiative to be hands on in the department, provide leadership to the department team leads, and be able to have a heavy focus on production while maintain quality standards.

Salary: $45,000 plus

If this opportunity meets your career goals and you possess the prerequisite skills and experience, submit your resume to jobs@opusscientific.com

Subject line: Parasitology Assistant Supervisor

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[Full-time] ARx Pharmaceutical Formulator at Adhesives Research, Inc.

2012-02-13 11:21:35

Location: Glen Rock. PA
URL: http://www.adhesivesresearch.com

Description:

Responsible for the design and development of new products, creation of new technologies and improvements to existing products.

* Defines project design input and strategy consistent with application requirements; reviews and shares with team members

* Develops formulations and related product constructions including raw materials, experimental evaluations (eg. compatibility, stability, performance, etc.) and specifications

* Designs and conducts experiments on lab and production scale

* Defines test methodologies and requirements; prepares test samples and conducts tests on raw materials, in-process intermediates and / or finished products as required

* Efficiently troubleshoots and solves technical problems

* Participates in the design and specification of production-scale prcoesses and validation

* Requires B.S. in Pharmaceutical Sciences, Chemistry, Chemical Engineering or Polymer/Material Science with a minimum of 2 years experience in pharmaceutical and / or drug delivery systems formulation; advanced degree and more experience preferred

* Polymer formulation and mixing process experience in drug delivery required with coatings experience preferred; transdermal and/or solid dosge form experience preferred

* Knowledge of and experience with cGMP, 21CFR, GLP required; IH and ISO experience preferred

Apply online at www.adhesivesresearch.com Careers, Job Postings

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[Full-time] Research Associate - Protein Formulations at Regeneron

2012-02-13 10:39:16

Location: Tarrytown,NY,United States
URL: http://https://sh.webhire.com/servlet/av/jd?ai=874&ji=2601034&sn=I

Description:

Job Description:

We are looking for a Research Associates in the Protein Formulation Development group, to participate in the development of both liquid and lyophilized protein formulations to Regeneron’s proteins.

Responsibilities:

Initiate and analyze research stability studies

Operate and maintain HPLCs

Perform other analysis SDS-PAGE, FTIR. DSC, IEF, MFI, & UV-Vis

Develop analytical methods

Requirement:

The position requires a B.S./M.S. degree in pharmaceutics, biochemistry, chemistry or biology.

In addition, 1 or more years of relevant laboratory experience in formulation development, analytical development, HPLC, electrophoresis, and UVN is spectroscopy is desired. Excellent oral and written communication skills are a must.

Benefits:

We offer a competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits.

Comprehensive relocation benefits are available, as required.

Apply online at:

https://sh.webhire.com/servlet/av/jd?ai=874&ji=2601034&sn=I

Company Description:

Regeneron currently markets ARCALYST ® (rilonacept) Injection for Subcutaneous Use and EYLEA ™ (aflibercept) Injection. Regeneron has therapeutic candidates in Phase 3 clinical trials for the prevention of gout flares, central retinal vein occlusion, diabetic macular edema, certain cancers, and rheumatoid arthritis. Additional therapeutic candidates are in earlier stage development programs in cholesterol reduction, allergic conditions, pain, and cancer. If you are looking for an uncommon opportunity — a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals — it’s time to consider Regeneron. Founded on the principle that strong science would lead to important new medicines, Regeneron has become an integrated biopharmaceutical company that discovers, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.

EOE/M/F/D/V

Disclaimer: Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the Internet or in any form and/or method without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex – www.candex.com

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[Full-time] Field Service Engineer (Denver) at Cepheid - US

2012-02-13 05:35:20

Location: Denver, CO
URL: http://track.tmpservice.com/ApplyClick.aspx?id=1379095-2406-4183

Description:

Successful candidate will be responsible for service support for our GeneXpert Product line, focusing on the Infinity system. The job will offer a challenging role for a individual who enjoys the fast pace of a rapidly growing company that has cutting edge technology & market leadership in the Molecular Diagnostic market. - Travel throughout North America & sometimes to Europe on short notice to support the company’s products & field service partners.- Work on-call designated weekends to provide service support w/thin a short period of time.- Partner with the Field Technical Service Support group to do installations & customer training.- Provide support of highly technical &/or sophisticated products.- Achieve & exceed Customer Satisfaction objectives – Perform routine standard procedures to isolate & fix problems in malfunctioning equipment or software. - Document & report the company’s product “design reliability” & “maintenance issues” &/or problems to technical support. – Bachelor’s in Electronics or an Engineering related discipline.- Min 5 yrs experience in field service. – Prior experience of providing hardware & software improvement feedback, lifecycle maintenance,sales support,& technical services preferred.- Capable of handling advanced complaints,troubleshooting,& knowledge of GMP & ISO requirements.- Strong leadership skills w/the ability to effectively supervise others’ when needed.- Possess the ability to work with customers & vendors at both a business & technical level.- Exceptional time management skill.- Conduct presentations of technical information concerning specific projects or schedules.- Experience with computer hardware & software.- Capable of interacting positively across all levels of the organization.- Capable of explaining technical procedures in writing or verbally.- Travel ~75% of the time candidate must live w/thin the territory);territory includes: CO, UT, WY,& NE.- Requires excellent systematic troubleshooting skills utilizing a structured & comprehensive process to determine the root cause & implement corrective action. – Troubleshooting skills w/automation robotics preferred.- Proficient in reporting activities,maintaining local spare parts inventory recording,& travel expenses.If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=1379095-2406-4183

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[Full-time] Field Service Engineer (Boston) at Cepheid - US

2012-02-13 05:31:19

Location: Boston, MA
URL: http://track.tmpservice.com/ApplyClick.aspx?id=1379312-2406-5683

Description:

Successful candidate will be responsible for service support for our GeneXpert Product line, focusing on the Infinity system. The job will offer a challenging role for a individual who enjoys the fast pace of a rapidly growing company that has cutting edge technology and market leadership in the Molecular Diagnostic market. - Travel throughout N. America and sometimes to Europe on short notice to support the company’s products and field service partners.- Work on-call designated weekends to provide service support within a short period of time.- Partner with the Field Technical Service Support group to do installations and customer training.- Provide support of highly technical and/or sophisticated products.- Achieve and exceed Customer Satisfaction objectives – Perform routine standard procedures to isolate and fix problems in malfunctioning equipment or software. - Document and report the company’s product “design reliability” and “maintenance issues” and/or problems to technical support. – Bachelor’s in Electronics or an Engineering related discipline required.- Min 5 yrs experience in field service required. – Prior experience of providing hardware and software improvement feedback, lifecycle maintenance, sales support, and technical services preferred.- Capable of handling advanced complaints, troubleshooting, and knowledge of GMP & ISO requirements is essential.- Strong leadership skills with the ability to effectively supervise others’ when needed.- Possess the ability to work with customers and vendors at both a business & technical level.- An exceptional time management skill is a must.- Ability to conduct presentations of technical information concerning specific projects or schedules necessary.- Experience with computer hardware and software is essential.- Capable of interacting positively across all levels of the organization is essential.- Capable of explaining technical procedures in writing or verbally is essential.- Ability to multi-task and prioritize events and maintain composure under high levels of demand is necessary.- Ability to work independently and be self – motivated is required.- Able to travel approximately 75% of the time.- Requires excellent systematic troubleshooting skills utilizing a structured and comprehensive process to determine the root cause and implement corrective action. If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=1379312-2406-5683

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[Full-time] Site Supply Analyst at Genzyme

2012-02-13 05:22:54

Location: Boston, MA
URL: http://track.tmpservice.com/ApplyClick.aspx?id=1378495-2406-4783

Description:

One of the world’s leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since its founding in 1981, the company has introduced breakthrough treatments that have provided new hope for patients. The company’s areas of focus are rare genetic diseases, multiple sclerosis, cardiovascular disease, and endocrinology. Genzyme is a Sanofi company. Genzyme’s press releases and other company information are available at www.genzyme.com.Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).Site Supply AnalystJob DescriptionThe Materials department interacts and coordinates with many cross functional groups including Quality, Safety, Manufacturing, Global Product Planning, Distribution, and Finance. The candidate would be..The scope of responsibilites include:- Plan and create work orders to support the manufacturing schedule.- Plan and create distribution requirement orders.- Coordinate deliveries to point of use sites & locations.- Coordinate supply requirements with gowning supplier.- Analyze data and make recommendations to assist in making safety stock decisions.- Support control of materials for both direct and indirect materials required to support manufacturingKey Skills:- In-depth, hands-on understanding of supply chain activities required to support commercial manufacturing- Review work order material issue & receipt variances and reconcile with manufacturing.- Identify and resolve conflicts for raw material availability- Maintain Mfg/PRO item master data for site planning requirementsQualifications- AS degree in Supply Chain and at least 3-5 years experience- Strong knowledge of MRP systems (prefer MFG Pro)- Ideal candidate must demonstrate excellent communication skills, strong problem solving- Proven ability to successfully manage the planning of products.- Knowledge and understanding of mfg, quality, supply chain, finance & planning.If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=1378495-2406-4783

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[Full-time] Principal Scientist, Pharmacokinetics at Sterling-Hoffman Life Sciences

2012-02-13 05:07:33

Location: NJ
URL: http://www.sterlinglifesciences.com

Description:

Our client is a publicly traded global pharmaceutical company that is focused on the development, manufacturing and distribution of innovative OTC therapies across a wide array of therapeutic areas. They boast exceptional revenue growth, an experienced management team, and products that are well positioned in their core segments. This is a unique opportunity for someone that wants to put their drive and initiative to work!

Responsibilities

Partial Job Description1) Review bio-analytical method validation reports from CROs and ensure compliance with compendia and other regulatory requirements2) Review summary basis of approval, prescribing information and other relevant literature of marketed products to prepare summaries in support of pharmacokinetic (PK) studies3) Design PK studies for demonstrating bioequivalence (BE) for solid, liquid, topical and specialized dosage forms, including parenterals, ophthalmics, otics, nasal sprays, metered dose inhalers, and transdermal patches4) Develop, review, and recommend scientifically supported PK study BE protocols for ANDAs (and some NDA products)5) Establish in-vitro in-vivo correlations6) Conduct model dependent and model–independent analysis of dissolution or drug release data. Analyze data using statistical tools (SAS, etc.) in order to demonstrate bioequivalence of proposed generics.7)The incumbent will work closely with Product Development scientists in India, US and Israel in designing pharmacokinetic (PK) studies for pharmaceutical products. The incumbent will act as an advisor in clinical drug development, CRO outsourcing, study monitoring, project management, and ensure study designs and their conduct are in compliance with US regulatory requirements.

Requirements

Qualifications / Skills Required1) 5 plus years of hands-on experience in independently designing pharmacokinetic studies for ANDAs and/or NDA submissions (preferably oral and topical dosage forms)2) PharmD or PhD in Pharmaceutical Sciences3) Expertise in Pharmacokinetics / Bioequivalence or Bio-pharmaceutics or associated area4) Generic industry experience for filing of ANDAs5) Well versed with FDA and EMEA guidelines on clinical studies and its conduct6) Good understanding of statistical methodology required in clinical sciences7) Demonstrated ability to work independently, manage and prioritize multiple projects, and perform concertedly in a team environment,8) Experience with an industry standard software for Non-compartmental Analysis and PK/PD modeling9)Team oriented, well-organized, strong written and verbal communication skills

TIP: Make sure your resume contains your FULL address (include zip code / postal code). If you are sending your resume, please make sure it is in MS WORD format.

Applicants are encouraged to apply directly by going to: http://bit.ly/wU4e1y

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[Full-time] Senior Clinical Research Associate at Sterling-Hoffman Life Sciences

2012-02-13 04:44:11

Location: MA
URL: http://www.sterlinglifesciences.com

Description:

Our client is a leading biopharmaceutical company.

Responsibilities

Partial Job Description1) Participate in clinical research programs by assisting the development of study protocols, case report forms and clinical reports2) Perform site monitoring visits3) Interface with site coordinators, field clinical staff, Clinical Research Organizations (CRO) and other company representatives4) Ensure that documentation from investigators and investigational sites meet FDA/GCP/ICH requirements5) Assist in designing, planning and implementing clinical research projects6) Assist in the design of study protocol, case report forms, informed consent for sound and thorough data to support the device through the approval process7) Review study records including case report forms, consent forms and other materials8) Assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meet the protocol requirements9) Organize data in systematic manner to allow for efficient and accurate clinical reports10) Perform site visits to ensure regulatory and study requirements being fulfilled11) Serve as a resource to site coordinators, investigators and other staff members regarding investigational products and protocols, including surgical case coverage12) Assist in writing the clinical portion of regulatory submissions13) Interface with clinical, regulatory, sales, marketing and administrative staff

Requirements

Qualifications / Skills Required1) Bachelor’s degree in Health profession, Science and/or Engineering field2) Experience of minimum 4 – 6 years in the medical device or pharmaceutical industry3) Involvement in clinical research activities (preferred)4) Excellent written and oral communication skills5) Computer literacy, proficiency in MS Office, Excel, PowerPoint etc.6) Excellent organizational skills and attention to detail7) Willingness to travel (approximately 35%)

TIP: Make sure your resume contains your FULL address (include zip code / postal code). If you are sending your resume, please make sure it is in MS WORD format.

Applicants are encouraged to apply directly by going to: http://bit.ly/ySZpAE

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[Full-time] Sr. Director, Clinical Affairs at Sterling-Hoffman Life Sciences

2012-02-13 04:42:09

Location: MA
URL: http://www.sterlinglifesciences.com

Description:

Our client is a leading pharmaceutical company.

Responsibilities

Partial Job Description1) Take responsibility for management of high quality clinical research programs to support timely approval of the company’s products2) Lead clinical research programs through development of study protocols, case report forms, study budgets and clinical reports3) Perform site visits4) Interface with investigators, site coordinators, in-house clinical staff, Clinical Research Organizations (CRO) and other company representatives5) Build and manage the clinical affairs organization6) Design, plan and implement clinical research projects7) Perform site visits to ensure regulatory and study requirements being fulfilled8) Ensure that documentation from investigators and investigational sites meet FDA/GCP/ICH requirements9) Prepare study protocols, case report forms, informed consent documents for sound and thorough data to support the device through the approval process10) Assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meet the protocol requirements11) Train study personnel on product and procedure and proctor surgical cases12) Organize data in systematic manner to allow for efficient and accurate clinical reports13) Assist in writing the clinical portion of regulatory submissions14) Provide clinical and technical feedback to design and development groups

Requirements

Qualifications / Skills Required1) Bachelor’s degree in Health profession, Science and/or Engineering field; advanced degree (preferred)2) Experience of 10 years in the medical device industry3) Experience of 5 years in a manager’s role4) Demonstrated experience in managing clinical research studies5) Proven track record of ever increasing responsibilities6) Possess strong leadership abilities enabling her/him to manage people and effectively drive projects in accordance with established departmental objectives7) Ability to work independently to drive projects in accordance with established company objectives8) Proven skills in leadership, management, communication and business strategy9) Self-starter10) Excellent written and oral communication skills11) Strong interpersonal and analytical skills12) Computer literacy, proficiency in MS Office, Excel, PowerPoint etc.13) Excellent organizational skills and attention to detail14) Willingness to travel (approximately 20%-35%)

TIP: Make sure your resume contains your FULL address (include zip code / postal code). If you are sending your resume, please make sure it is in MS WORD format.

Applicants are encouraged to apply directly by going to: http://bit.ly/w7Arh7

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[Full-time] Sr. Manager, Scientific & Medical Writing Job at Celgene Corporation

2012-02-11 00:00:04

Location: Summit, NJ, US
URL: http://jobs.celgene.com/job/Summit-Sr_-Manager%2C-Scientific-&-Medical-Writing-Job-NJ-07901/1722321/?feedId=696&campaignId=29&utm_source=FierceBiotech&utm_campaign=Celgene_Tier1

Description:

Job Title:
Sr. Manager, Scientific & Medical Writing

Job ID:
12818

Location:

Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time

Regular/Temporary:
Regular

Category:

Clinical

Department:

Scientific & Medical Writing – 3673

Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Masters degree in Biomedical Science (PhD, PharmD, MD preferred) with 5+ years in the pharmaceutical industry, in a CRO, and/or graduate level research work, including 4+ years’ writing experience and 1+ years staff management.

Responsibilities will include, but are not limited to, the following:

* Contribute to the strategy for document preparation, SOPs and guideline documents including time frames that meet or exceed company standards and the document review processes.
* Contribute to management of outsourced medical writing resources, in assigned product areas
* Revise and update content templates for clinical documents that are consistent with FDA and ICH
* Working with other relevant line functions, prepare phase 1 – IV clinical and regulatory documents and submissions, including Investigator Brochures, clinical study reports, integrated summaries of efficacy and safety, registration dossiers, package inserts, and responses to health authorities.
* Train and guide other writers (in-house or contract) in company policies and procedures related to document preparation, in assigned therapy areas.
* Review work of other writers (in-house or contract) for accuracy, quality, focus, and adherence to format and stylistic requirements, in assigned therapy areas.
* Facilitate document review meetings and discussions.
* Participate in study and clinical team meetings and assist the teams in resolving issues related to document preparation.
* Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
* Preparation of presentations for major external meetings.
* Transfer and present clinical / regulatory data to Marketing for journal submissions.

Skills/Knowledge Required:

* Previous leadership or supervisory experience
* Knowledge of FDA and ICH guidelines
* ?Ability to analyze industry trends for study reports and international dossier preparation, including electronic document submissions (eCTD), and synthesize standardized solutions
* ?Extensive experience writing all types of clinical & regulatory documents and with registration dossiers for worldwide use
* ?Knowledgeable in preclinical development including discovery, toxicology etc.
* ?Ability to work with complex projects and within cross-functional teams
* ?Experience working with CROs
* ?Expertise in multiple therapeutic areas
* ?Excellent grammatical and communication skills, both written and oral
* ?Expertise in MS WORD, including the ability to solve technical problems with WORD templates

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the “at-will” employment relationship between the employee and Celgene.

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