Biotechnology Jobs

Job Title: Postdoctoral /Research Assoc Company: Confidential Location: Fort Worth, TX Description: Requirements: A Ph.D. degree in biological science is required. Experience in handling, care, and use of experimental animals is mandatory. Candidates must also have experience in microbiological techniques, molecular biology techniques, working with infectious pathogens, as well as good written and verbal communications skills. Responsibilities: The candidate will be responsible for conducting research on vivo model of ocular infection; studying the immune and inflammatory mechanisms of ocular infection; evaluation of gene expression (mRNA and protein) using a variety of techniques including molecular cloning, RT-PCR, IHC, western immunoblotting, monoclonal antibody, transfection, transduction, and RNA interference. The University of North Texas Health Science Center at Fort Worth is an Equal Employment Opportunity/Affirmative Action institution.

Job Title: Excellent Opportunity for QC Microbiologist Company: Lab Support, A Division of On Location: Plymouth, IN Description: OA Lab Support has an excellent opportunity available for QC Micro Lab Technician to work with our client in the food and beverage industry in Plymouth, Indiana. This position is a possible contract to hire opportunity. Job hours could becould be either day or night shift (5am-5pm or 5pm-5am), there is also a weekend rotation on Saturday and Sunday. Hiring company is Europe's number one fruit processing company and one of the leading brand manufacturers of jams, sweets and custard-based dessert. The Company's first North American operation is located in Plymouth, Indiana, where we produce fruit and dairy preparations for a variety of customers including yogurt, ice cream and bakery manufacturers. This position will report to the Lab Supervisor and the Director of Quality Assurance. The ideal candidate will have a strong background in food microbiology. This position will be responsible for the microbiological analysis of the food samples and also for authorizing release of product. The position will also control and audit the environmental conditions of the plant. Experience as a chef or baker would be beneficial as well as SAP experience. The hourly pay range is based on the following education/skill levels in the microbiological field: High School Diploma Must have 4 to 5 years of Micro Lab Experience. Associates Degree Must have 1 to 2 years of Micro Lab Experience. Bachelors Degree No experience. Strong knowledge of MS Office is required. Must be able to demonstrate strong written and verbal communication skills, decision making ability and attention to detail. We offer an excellent benefits and compensation package to include: medical, dental, prescription, vision, 401K, short term and long term disability plans, as well as life insurance. Company: Lab Support, a division of On Assignment Job Status: Full Time, Employee Category: Quality Assurance/Safety Work Experience: 2+ to 5 Years Career Level:Entry Level Education: High School or equivalent Apply Now! Email this Job to a Friend Click here to see all company opportunities

Job Title: Senior Medical Director, Pharmacovigilance (6373) Company: Cubist Pharmaceuticals Location: Lexington, MA Description: 6373 Job Description Position Summary: Reporting to Santosh Vetticaden, M.D., Ph.D., Cubist's CMO and SVP, the Senior Medical Director, Pharmacovigilance (PV) will be responsible for providing leadership to the PV group at Cubist and developing that group into a best-in-industry group capable of meeting the pharmacovigilance need for Cubist products in development and commercialization both now and in the future. This role will require an experienced executive who can not only handle the day to day needs of the PV department, but who can also develop and executive strategic plans for the function within the Company. Cubist is on a growth trajectory and the successful hire will need to ensure that the PV function is well-positioned to support the current and anticipated increased PV needs in the future. Additionally, this role will have ultimate oversight for the following named responsibilities: Developing PV plans for planned or ongoing clinical studies. Managing safety reporting activities outsourced to CROs or other service providers. Working closely with project and study teams to ensure that PV needs are addressed. Working closely with our partners that commercialize Cubicin in countries outside of the United States to ensure PV needs are addressed Maintaining a comprehensive safety signaling program for delegated Cubist products. Developing, implementing, and maintaining pre- and post-approval product-specific risk management plans. Assisting with the development and critical review of various product documents (e.g., investigator brochures, protocols, core data sheets). Participating in the development and monitoring of registry or epidemiologic studies associated with approved products. Serving as product safety expert on assigned teams (e.g., product labeling committees); Performing medical review of individual case safety reports. Analyzing aggregate safety data for periodic report (e.g., PSUR) preparation, internal clinical safety review, and preparation of ad hoc reports such as regulatory authority response documents. Tracking and trending safety issues being monitored and maintaining appropriate documentation of activities and findings. Formulating and implementing SOPs, process flow maps, and other quality documents. Minimum Basic Qualifications: M.D., D.O. or equivalent degree with clinical practice experience (primary care or internal medicine subspecialty preferred) beyond residency. A minimum of 5 years of experience within the pharmaceutical industry, with the most recent 2 years within a global drug safety/pharmacovigilance department, is required. The ideal candidate will have 7 to 10 years of experience. 4+ years of experience with safety signaling, assessment of drug risks and benefits, and safety assessment of marketed drugs and those in development is strongly preferred. Experience in pre- and post-marketing drug safety, with the ideal candidate having global Phase 1-4 experience. Experience Required: Epidemiology training with related field experience is strongly preferred. Excellent interpersonal skills and communication skills, including oral presentation and technical manuscript writing. Competence with technology applications including commercial safety databases. Ability to work effectively as an individual contributor and as project team member; collaborative spirit. Thorough understanding of the regulatory environment for PV, with working knowledge of worldwide regulations and guidelines. Demonstrated record of incisive problem-solving. Ability to analyze and interpret complex and multivariate safety issues. Ability to understand and apply biostatistics and epidemiology methodology. Effective project management skills; ability to prioritize workload and work effectively, sometimes within resource constraints. Ability to recruit and manage external consultants as needed. Demonstrated ability to provide critical and timely insight. Familiarity with industry principles of drug development, pharmacology and toxicology. Desired Competencies and Qualifications: A detail oriented person who also has the ability to think strategically about the "big picture." Possess a high degree of personal and professional credibility enabling successful relationships with large pharmaceutical partners. This hands-on, "roll up the sleeves" executive will have an entrepreneurial attitude with the corresponding entrepreneurial skills. This person will be willing to take risks, have a significant energy level, a driving sense of urgency and a seasoned "make it happen" orientation. The highest degree of Professional Ethics and Integrity. Work Environment: Office Some business travel Walking between offices and buildings Physical Demands: Sitting, working at a computer To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Job Location Lexington, MA, US. Position Type Full-Time/Regular

Job Title: Research Associate III Company: Kelly Services, Inc. Location: Los Angeles, CA Description: Research Associate III Responsible for performing laboratory bench and pilot plant scale experiments, such as alcohol precipitation and filtration process. The incumbent, under minimum supervision, conducts routine and non-routine analytical testing, data tracking and data analysis. Duties Conduct laboratory bench and pilot plant scale protein purification studies using alcohol fractionation processes and filter press separation, including sample collection, sample preparation and sample submission Conduct biological and chemical analyses of in-process samples and final product in a timely manner Prepare study protocols/final reports and maintain data integrity Prepare buffers and solutions Perform equipment maintenance and ensure working area is maintained in a 5S state Ensure personal training requirements are met Qualifications Understanding of biochemistry or protein separation Understanding of plasma fractionation process is preferred Ability to follow written procedures in performing tasks repeatedly Ability to handle multiple tasks concurrently while paying attention to details Self motivated and takes personal responsibility for getting the job done Ability to analyze and interpret scientific and statistical data Strong computer skills (MS Word, MS Excel, MS PowerPoint) Good laboratory skills and writing skills Able to work independently and follow specific instruction to accomplish tasks. Education Masters Degree or PhD in Chemistry or Biochemistry Physical Demands Must be able to lift, push, pull and carry up to 50 lbs In general, the position requires a combination of sedentary work and observing conditions in the facility. Environment Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be work in the work environment Will work in a cold, wet environment and climb up and into large processing tanks for cleaning Will be working in a loud area that requires hearing protection and other protective equipment to be worn Will work around chemicals such as alcohol, acids, buffers and diatomaceous earth that may require respiratory protection. May be required to work or be assigned to a different shift as needed Must be able to work overtime May be required to work in a confined area Inside working conditions Some clean room and cool/hot storage conditions Duration 6 Month Contract with possibility of temp to hire, depending on performance Salary D.O.E Kelly Scientific Resources (KSR) provides consultative scientific staffing solutions for a broad spectrum of industries on a temporary, project, temporary-to-fulltime, and direct hire basis Since 1995, Kelly Scientific has placed over 30,000 scientists with leading companies around the globe. 95% of the Fortune 500 work with us, as well as hundreds of mid and small-cap companies, emerging biotech and boutique research laboratories with tremendous growth potential. KSR is the specialized scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. For more information visit us at www.kellyscientific.com. For immediate consideration, email your resume in a Microsoft Word attachment to: Register to View or fax to Register to View

Job Title: Investigator Compliance Specialist/Sr. Compliance Specialist Company: Genentech, Inc. Location: South San Francisco, CA Description: ABOUT US For more than 30 years, Genentech has been at the forefront of the Biotechnology industry, using human genetic information to develop novel medicines for serious and life-threatening diseases. Today, Genentech is among the world's leading biotech companies, with multiple therapies on the market for cancer and other serious medical conditions. Our employees cite the chance to make a difference in the lives of patients as the number one reason they enjoy working at Genentech. In hiring new employees, we look for people who are inspired by this mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset. The following opportunity exists in our South San Francisco, CA facility: Investigator Compliance Specialist/Sr. Compliance Specialist Job ID: Register to View South San Francisco, CA RESPONSIBILITIES: Compliance Specialist/Sr. Compliance Specialist- Investigator The Compliance Specialist/Sr. Compliance Specialist - Investigator will conduct and track individual investigation matters related to enforcement within the healthcare industry. This includes, but is not limited to, compliance with laws enforced by the Food and Drug Administration, Health and Human Services Office of Inspector General, Department of Justice and State Attorney Generals and various agencies. The Investigator works closely with HR,Legal, Security functions, and other members of the Healthcare Compliance Office (HCO) across the spectrum of investigations management, from initial report and assessment through investigation and application of disciplinary action. This position reports to the HCO Director of Auditing, Monitoring, Investigations, and Risk Assessments. - Responsible for understanding the Genentech organization, particularly corporate policies and guidelines, as well as internal organizational dynamics. - Collaborate with HR,Legal, Security functions, and other members of the HCO on investigations. - Ensure appropriate processes are in place to fulfill reporting and oversight of compliance related investigations and incidents. - Develop strategies for the investigation data collection and analysis. - Investigate, or coordinate the investigation, using a variety of evidence, including witness interviews, business records, and other official documents. Prepare and coordinate the preparation of complex case documentation to fully Support findings. - Identify and analyze potential trends and/or signals across compliance related investigations and incidents. - Assist with all other compliance-related duties and special projects as assigned. - Effectively work with outside counsel, when applicable. REQUIRED QUALIFICATIONS, CORE COMPETENCIES, AND EXPERIENCE - BS/BA; advanced degree preferred (e.g., JD, MBA). - Relevant Professional Qualifications a plus (e.g., Certified Fraud Examiner). - 3 years (Compliance Specialist) - 5 years (Sr. Compliance Specialist) experience in the pharma/bio-tech field. - Significant experience in conducting investigations (e.g., law enforcement, regulatory agency, internal investigations, forensic Accounting investigations/consulting). - Significant familiarity with US regulatory requirements related to the development,Manufacturing, and Marketing of bio/pharmaceutical products. - Significant familiarity with industry codes and standards related to industry interactions with Healthcare Professionals (e.g., PhRMA Code). - Ability to travel (approximately 25% of the time). For Compliance Specialist: - High competency in the following areas: priority setting, multi-tasking, planning, process and project oriented, oral and verbal communication, strategic ability, organizational agility, effective decision making, results oriented, team participation, time management, ability to work under pressure and with tight deadlines. - Demonstrated ability to collaborate in a complex and fast paced matrix environment. - Excellent written and oral communication skills, with a proven ability to communicate effectively with senior-level executives - Ability to work independently and as part of a team. - Strong analytical and problem solving skills. For Sr. Compliance Specialist (in addition to those listed above): - Takes initiative and has the ability to work without appreciable direction. - Understands and abides by scope of decision making authority. - Makes decisions with minimal delay as appropriate. - Excellent judgment - sizes up situations accurately in own area of work and looks beyond immediate problems to consider underlying causes and seeks to address these. DIVISION: Legal REQUISITION NUMBER: 1 Register to View Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. To learn more about our current opportunities, please visit: http://careers.gene.com and reference Req. # Register to View . Please use ?Web ? BAJobs? when a source is requested. Genentech is an Equal Opportunity Employer.

Job Title: Associate Medical Director - Neurology - Northeast-1001485 Company: EMD Serono Location: Rockland, MA Description: At EMD Serono, Inc. our strength is our people! About the Company EMD Serono, Inc. is a leader in US biotechnology, focusing on reproductive health, metabolic endocrinology, and neurology. More than 500 people work in the world-class facilities in Rockland, MA, and approximately 250 work in the field. Description The Associate Field Medical Director is responsible for developing and maintaining a close relationship with Medical Affairs and utilizing materials to communicate the benefits of our products and to explain safety related issues. They will also conduct training activities to internal and external parties (sales, medical science liaisons, healthcare providers, managed care, etc.). They must be well versed in the advanced science and medicine of the specific disease process, treatment data and safety concerns and share this knowledge appropriately in the conduct of their function relative to EMD Serono's products. This field based position requires approximately 75% travel to regional or national areas in need of medical support Specific Responsibilities include: Participate in planning, execution and interpretation of the medical coverage for the specified therapeutic area. Must be able to discuss and support the ongoing safety issues and support all training activities. Represent EMD Serono, Inc. at specific educational events, programs, medical meetings, conventions and congresses, managed care presentations and Advisory Boards Identify areas for research collaboration with institutions and unsolicited research proposals for studies that would add new information on EMD Serono's science and medicine Actively involved in the training of product representatives; Medical Science Liaisons, Marketing, Nurse Educators, MS Life Line (MSLL) and new hires Qualifications EDUCATION/ PROFESSIONAL SKILLS & EXPERIENCE M.D. or D.O. Degree required. Fellowship or residency training and clinical experience in specific therapeutic area is preferred Previous experience in supporting and/or partnering with Sales, Research and Development, Regulatory and Pharmacovigilence is preferred Previous experience in analyzing, writing and publishing medical literature is preferred as well as experience in conducting formal presentations to healthcare providers Experience within the Biopharmaceutical Industry is preferred Excellent scientific presentation and public speaking skills are essential Clinical opinion leaders should perceive the physician in this position as a peer in their area of specialization Click the link below and open the door to the future by submitting your resume today! EMD Serono 1001485 Awards & Recognition June 2009, The Boston Business Journal recognizes EMD Serono as one of the Best Places to Work! May 2009, The Scientist magazine names EMD Serono one of the best place to work in the life sciences industries! October 2008, EMD Serono Named as a Top Employer by Science Magazine! more The Company is an Equal Employment Opportunity Employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, disability, military or veteran status, genetic information, or any other classification protected by applicable federal, state, and local law.

Job Title: Senior Manager Regulatory Affairs CMC Company: Shionogi USA, Inc. Location: Florham Park, NJ Description: Shionogi Inc. Senior Manager Regulatory Affairs CMC Shionogi Inc. is the US subsidiary of a leading Japanese pharmaceutical company, Shionogi & Co., Ltd. We are in the unique position of having the financial backing of a well-established, leading Japanese pharmaceutical company, matched with the entrepreneurial spirit of a start-up company. Responsibilities Develop effective CMC regulatory strategy for assigned development projects and/or marketed products and recommend such strategies to the Regulatory Affairs Management or other colleagues as appropriate. Provide interpretive analyses of complex regulatory guidance documents, regulations or directives that impact Shionogi products and operations and advise manufacturing/QA groups regarding their applicability and impact. Maintain awareness of and expertise in CMC related regulations and guidelines Review CMC documentation for regulatory submissions, providing advice regarding regulatory acceptability of plans for drug development, labeling, or responses to health authorities. Ensure consistency, completeness, and adherence to FDA standards for all regulatory submissions Author and maintain CMC sections of IND and NDA applications, supplements and annual reports and renewals pertaining to on-going application maintenance in accordance with established timelines and submission dates. Liaison with FDA Chemistry Reviewer on product related issues. Lead CMC submission activities for assigned projects. Make quality regulatory decisions as necessary, balancing risks and benefits. Represent Regulatory CMC in interdisciplinary regulatory and technical project teams. Review and approve change control documents. Provides feedback requesting appropriate documentation and provide regulatory strategy. Track, maintain and coordinate multiple CMC project timelines and coordinate on-going activities across multiple functions. Communicate critical topics to appropriate management level. Qualifications Minimum 4 years regulatory affairs CMC experience. Minimum 8 years experience in the pharmaceutical industry. Some manufacturing or quality assurance is required. A Bachelor's Degree in Chemistry, Pharmacy or Biology required. Demonstrated knowledge of U.S. CMC regulatory requirements for pharmaceutical development and prior hands-on experience writing CMC submissions, including DMFs, NDAs, INDs, Supplements and annual reports. eCTD experience preferred. Track record in successfully leading/working in interdisciplinary teams, and of planning, coordinating and leading activities simultaneously on multiple projects. Ability to effectively organize and prioritize tasks to achieve established deadlines. Strong verbal and written communication skills. Good organizational skills. We offer a competitive compensation package and a comprehensive benefits program. For consideration, please email your resume/CV to Register to View -usa.com . Equal Opportunity Employer. PRINCIPALS ONLY PLEASE.

Job Title: Research Associate Company: Kyowa Hakko Kirin Ca, Inc. Location: La Jolla, CA Description: At Kyowa Hakko Kirin California, Inc. (KKC), we believe our team is the reason for our success and we are interested in quality people with a winning attitude to join our team! www.kyowa-kirin-ca.comKyowa Hakko Kirin California, Inc. is a wholly owned U.S. subsidiary of Kyowa Hakko Kirin. Kyowa Hakko Kirin California was established in San Diego, California in 1988, and acts as KHKs primary drug discovery research facility in the US, facilitating the companys pharmaceutical development efforts in North America.. Kyowa Hakko Kirin California utilizes proprietary antibody engineering technologies (including human/humanized antibody and Potelligent) in its research and development program of antibody based therapeutics for infectious and autoimmune diseases.Our dedicated team is a focused and interactive group involved in pursuing innovative biomedical research and technologies targeted towards the development of novel therapeutics. To further expand our research efforts on infectious diseases and disorders of the immune system, KKC has been a major corporate sponsor of the La Jolla Institute for Allergy and Immunology (LIAI), a not-for-profit research institute, since 1988. Research Associate (Molecular Biology):This position will contribute to the development of novel antibody therapeutics for autoimmune and infectious diseases. Primary Responsibilities:?Cloning new antibody target molecules?Expression of recombinant proteins in various expression systems?Generation of stable transgenic cell lines ?Creation of reagents used for screening purposes during the process of monoclonal antibody generation. ?Immunologic characterization of samples from in vivo proof of concept studies for antibody therapeutics

Job Title: Analytical Chemist & Senior Microbiologist Company: Company Confidential Location: Commerce, CA Description: We are a leading food and environmental testing laboratory that is rapidly growing and we arelooking to expand our team. We are looking for an Analytical Chemist andSenior Microbiologist. AnalyticalChemist Description Our Lab is looking for an OrganicChemist to join our team. A qualified candidate must be responsible, organized, self-motivated, be able to work in an extremely fast-paced setting, be able to adapt quickly, and work well in a team setting. Candidate must have a degree in Chemistry. This position involves development and application of sophisticated methods utilizing LC/MS/MS instruments. Hands-on experience using this instrument is a must. Candidate will assist in reviewing protocols, technical reports and standard operating procedures (SOP's). Candidate must possess strong organization, communication and time management skills. Effective problem solving and trouble-shooting skills are also a must. Position Requirements BS in Chemistry required but MS in Chemistry preferred. At least 1-2 years hands-on LC/MS/MS experience. Work independently and interact well with other team members. Familiarity with Chemistry and other chromatographic instrumentation. Senior Microbiologist Senior Microbiologist duties include but are not limited to: receiving samples, logging in samples, preparing serial dilutions, preparing enrichments, and initiating analyses. Coordinating challenge studies and shelf-life studies. Analytical techniques include: pour plating, spread plating, MPN tubes, petrifilm, pathogen enrichments, pathogen confirmations, running automated-PCR and ELISA assays. A successful candidate must be able to work in a fast paced environment, work well with others, work efficiently with minimal supervision, have flexible availability, and a positive attitude. Knowledge of aseptic technique and good laboratory practices a must. BS in a related science is required. BS or MS in microbiology/food science is a plus. This is a full-time position, flexible schedule required, may include weekends.

Job Title: Temporary field biologists needed ASAP Company: Location: Tampa, FL Description: Organization: GPI SOUTHEAST, INC. Title: ENTRY LEVEL BIOLOGISTS/TEMPORARY POSITION (through 10/31/10) Location: Charlotte County, FL, USA (Cecil M. Webb Management Area) and Hernando County (Chassahowitzka Wildlife Refuge) Application Deadline: 9/1/10 Posted: 8/25/10 Firm Profile: GPI Southeast, Inc. (GPI-SE) is a Florida subsidiary of the Engineering News Record Top 100 Engineering consulting firm, Greenman-Pedersen, Inc. (www.gpinet.com), established in 1966. GPI?s Florida offices specialize in natural resource issues important to water suppliers, municipalities, land managers, and permitting agencies, assisting them with the monitoring, management, and protection of their ecological resources. GPI-SE?s environmental team, primarily located in Tampa, includes 8 highly experienced and dedicated environmental professionals that perform specialized ecological monitoring and reporting projects including: water use permitting and compliance, quantitative vegetation monitoring; environmental impact and wetland health assessments; habitat mapping; water quality permitting and compliance; threatened and endangered species surveys; statistical and spatial analyses; database and geodatabase design/data management; wetland jurisdictional delineations; conservation easement baseline documentation reporting; and mitigation design and implementation. Job Description: GPI-SE is looking for 2-4 entry level Biologists to assist with vegetative field monitoring to start immediately. The project period will occur between September 7, 2010 - October 31, 2010 (plus/minus a couple of days/weeks), and is located at sites in Hernando and Charlotte County. Training will be provided, though applicants should have familiarity with collecting ecological field data, comfort using GPS Trimble and other field equipment, and the ability to withstand long field days in Florida?s harsh summer climate. Work will be performed in uplands and wetlands. While the project is physically and mentally demanding, it also is a lot of fun and a great experience and may lead to future employment opportunities with GPI-SE. Minimum Requirements ? Bachelors of Science degree in the natural sciences (e.g., biology, botany, ecology, environmental science, zoology) ? Ability to work efficiently during hot summer conditions, often without shade, with diverse team members. Work is conducted in a smoke-free environment. ? Ability to work well with others. ? Willingness to share residency at rental properties/lodging facilities during project workdays. ? Comfort using field equipment, including a compass. ? Plant identification experience, especially exotic species, preferred. Desired Skills ? Knowledge of basic plant ecology and community characteristics and definitions. ? Experience in the use of plant community monitoring methods including: basal area estimation using BAF prism, transects, and quadrats for cover estimation. ? Experience navigating by GPS, including in areas of dense vegetation and canopy. ? Experience collecting and recording field data, specifically with a Trimble unit. Benefits and Pay This is a temporary position, thus no benefits are offered. The pay rate is $14hr, commensurate with experience, with a possibility for some straight pay overtime. *Project applicants will commute daily to project site at Chassahowitzka daily for first half of project (no mileage), and live during the week in rental property/lodging (provided) near Cecil Webb Mgmt Area for 1+ months during 2nd part of project. If interested, please send resume (preferably by email) to: Scott M. Deitche Water Resources Project Manager GPI Southeast, Inc. Register to View Register to View