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TEMPORARY MANAGER OR SR. MANAGER, BIOANALYTICAL
Posted by jobs January 5th, 2012 .
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Hiring Company: Halozyme Therapeutics

Job Code: 2011-2852-Sr. Mrg

Location: San Diego

Job Type: Preclinical Development – Bioanalytical & Pharmacokinetics

Compensation: $ Commensurate with experience

Description: POSITION SUMMARY:
The qualified individual will be responsible for the development, implementation and interpretation of various bioanalytical (PK, immunogenicity, and pharmacodynamic biomarker) assays used to support pre-clinical and clinical development of product candidates in development. Studies will focus on bioanalytical assay development-quantify in vivo levels of drug (and metabolites) for assessing pharmacokinetic parameters of drug candidates in accordance with current guidelines and industry standards.
The candidate will be an energetic hands-on laboratory scientist responsible for the design, development, optimization, qualification and implementation of bioanalytical assays with proven leadership qualities. This includes planning and execution of various types of assay systems (e.g. enzymatic assays, immunoassay, immunogenicity assays, cell-based assays, biochemical assays, and biomarker assay development) to quantify drug levels and activity in various matrices as well as supervising at least one associate. The individual must be organized and efficient and -able to work on multiple programs independently with minimal direction to meet corporate goals and objectives. A successful candidate will also have strong interpersonal skills to communicate results to colleagues in a timely manner as well as provide oversight for activities at Contract Research Organizations The successful candidate will represent Bioanalytical on.internal and external project teams.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These include, but are not limited to:
• Significant knowledge and hands on experience with an excellent understanding of method development and troubleshooting; preference for experiences with immunoassay techniques, ELISA, neutralizing antibody assay; kinetic assays for enzyme activity, and/or LC/MS quantification.
• Ability to independently design, execute and interpret experiments in order to generate technical reports.
• Clear and effective written and verbal communication skills.
• Strong interpersonal skills including excellent verbal and written communications skills, time management, decision-making, presentation, and human relations skills.
• Lead and supervise the bioanalytical group as well as bioanalytical studies at CROs,
• Collaborate with scientists within pre-clinical and other departments and play a key role
• representing BA on project teams.
• The ability to handle multiple projects simultaneously and work in a fast-paced environment.
• Participate in preparation of regulatory submissions.
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ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:

• Technical support of pre-clinical pharmacology, toxicology, and bioanalytical sciences groups as
required.
• Other functions as determined by the pre-clinical group.

• Other duties as assigned.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

• B.A., B.S. or M.S. in Biological Sciences or equivalent experience, with a
minimum of 12 years of experience in a bioanalytical/analytical laboratory
environment, and demonstrated leadership or management experience for at least
three years. Alternatively, a Ph.D. in Biological Sciences or equivalent experience,
with 8-10 years of experience in a bioanalytical/analytical laboratory environment,
and demonstrated leadership or management experience for three or more years.
• Candidates must have knowledge and work experience in bioassay method
development (e.g. LC/MS, immunoassay, ELISA, ECL biomarker methodology and
strategies, cell-based assays), optimization, qualification/validation.
• Operating knowledge of suitable computer software packages.
• Ability to write clear, concise technical reports and attention to detail is essential.
• Demonstrated leadership or management experience for three or more years.
• Demonstrated experience managing extramural programs at Contract Research
Organizations.
• Familiarity with GLPs is desirable.
• Hands-on experience with regulatory submissions

TECHNICAL KNOWLEDGE REQUIRED:

Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: e.g., ELISA plate reader, MSD, TaqMan, HPLC, Luminex, etc.

Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: Prism GraphPad, Softmax, MSD, JMP, StatLIA, WinNonlin, etc.

INTERNAL AND EXTERNAL RELATIONSHIPS:

• It is imperative that this individual be first and foremost a team player. They will be responsible to ensure that adequate resources are available and provide regular updates to their supervisor and team members. This will require that the individual be transparent and openly communicate information in a timely manner.

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EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.

TRAVEL:

Travel may be required up to 20% of your time

Link for more information: http://www.halozyme.com/Careers/Career-Opportunities/default.aspx

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TEMP TO HIRE – ASSOCIATE DIRECTOR – BIOANALYTICAL TECHNICAL OPERATIONS
Posted by jobs January 5th, 2012 .
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Hiring Company: Halozyme Therapeutics

Job Code: 2011-2853-AD

Location: San Diego

Job Type: Preclinical Development – Bioanalytical & Pharmacokinetics

Compensation: $ Commensurate with experience

Description: POSITION SUMMARY:
The qualified candidate will be a highly motivated and seasoned professional with experience in bioanalytical testing to support the development of recombinant biopharmaceuticals. The candidate will oversee technology transfer and technical operations for specific GLP bioanalytical (PK, immunogenicity, and pharmacodynamic biomarker) assays that support pre-clinical and clinical testing of specific recombinant biological product candidates.

The candidate will be responsible for technical operations to support specific assays and critical reagents at CRO’s used to quantify in vivo levels of protein drugs and anti-drug antibodies in accordance with current guidelines and industry standards. The individual will also be responsible for compiling datasets to support regulatory filings for specific programs.
The individual must be organized and efficient and able to work on multiple programs independently with minimal direction to meet corporate goals and objectives. A successful candidate will also have strong interpersonal skills to communicate results to colleagues in a timely manner as well as provide oversight for activities at Contract Research Organizations. Finally, the candidate will generate documentation to support regulatory filings.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These include, but are not limited to:

• Significant knowledge and experience working within the regulatory framework and considerations for bioanalytical testing of recombinant biotechnology-derived products.
• Significant knowledge and experience in the pharmacokinetic evaluation of parenteral therapeutics, drug metabolism, and protein/drug properties governing their in-vivo distribution.
• The applicant must possess the ability to work effectively in a fast paced start-up setting.
• Clear and effective written (report writing) and oral communication (presentation) skills are essential.
• The candidate must have the ability to work independently as well as in a team environment.

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:

• Technical support of pre-clinical pharmacology, clinical, and bioanalytical sciences groups as
required.
• Other functions as determined by the pre-clinical group.
• Other duties as assigned.

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EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

• Advanced degree (PHD, MD, MSc or M. Pharm) in Pharmacology or related discipline is required.
• Significant knowledge and experience working within the regulatory framework and considerations for bioanalytical testing of recombinant biotechnology-derived products.
• Bioanalytical background with at least 8-10 years experience hands on experience in a pre-clinical and clinical drug development environment.
• At least 3 years experience in evaluation of biological therapeutics, preferably in a clinical or non-clinical setting biologics environment.
• In depth knowledge of PK and PK/PD evaluation techniques preferred. Experience of working in a team environment a plus.
• Knowledge of regulatory requirements and experience in dealing with regulatory authorities either through written summaries or oral presentations is desired, but not essential.
• The individual must be very effective at technical and scientific problem solving in a project driven, multi-disciplinary international environment, able to focus and work on
several projects simultaneously and must possess excellent interpersonal, leadership and
• teamwork skills with very good organizational skills.
• Must be fluent in written and spoken English.

TECHNICAL KNOWLEDGE REQUIRED:

Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: e.g., ELISA plate reader, MSD, TaqMan, HPLC, Luminex, etc.

Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: Prism GraphPad, Softmax, MSD, JMP, StatLIA, WinNonlin, etc

INTERNAL AND EXTERNAL RELATIONSHIPS:

• It is imperative that this individual be first and foremost a team player. They will be responsible to ensure that adequate resources are available and provide regular updates to their supervisor and team members. This will require that the individual be transparent and openly communicate information in a timely manner.

EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.

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TRAVEL:

Travel may be required up to 30% of your time

TO APPLY: Please apply directly online by going to the URL provided.

Link for more information: http://www.halozyme.com/Careers/Career-Opportunities/default.aspx

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Web developer
Posted by jobs December 9th, 2011 .
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Hiring Company: Ambry Genetics

Location: United States

Job Type: Full time

Compensation: $ Ambry Genetics offers a competitive salary commensurate with experience and qualifications. Benefits include health, dental, vision, 401K and 125c.

Description: Ambry Genetics is a thriving and fun company that provides molecular diagnostics and biotechnology services. The company is located in Aliso Viejo, California, and is rapidly expanding across multiple markets. We are seeking to hire a full-time Web Developer with an emphasis on visualization and presentation of biology data.

Roles and Responsibilities:

As a Web Developer in the Bioinformatics Department, the person will have the opportunity to work with scientists and programmers in various departments to develop a variety of web tools and programs with the emphasis on presenting and visualizing biological data. This is an amazing opportunity to get in to one of the fastest growing fields in the health care industry.

Required Qualifications:

• LAMP stack (Linux, Apache, PHP, MySQL).
• HTML, CSS, JavaScript, SQL, jQuery, jQuery UI.
• Knowledge of web standards and browser compatibility issues.
• Highly self-motivated, able to work independently and efficiently to meet deadlines.
• B.S. degree in Computer Science with at least 3 years of web development experience, or equivalent experience.

  Preferred Qualifications

• Preference given to candidates with experience developing in the healthcare/biotech R&D.
• Excellent organizational and time management abilities.
• Excellent oral and written communication skills.

Interested candidates should submit a letter of interest and curriculum vitae to xli@ambrygen.com

Link for more information: http://www.ambrygen.com/Careers.html#Bioinformatics Web Developer

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Bioinformatics Analyst
Posted by jobs December 9th, 2011 .
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Hiring Company: Ambry Genetics

Location: United States

Job Type: Full time

Compensation: $ Ambry Genetics offers a competitive salary commensurate with experience and qualifications. Benefits include health, dental, vision, 401K and 125c.

Description: Ambry Genetics is a thriving and fun company that provides molecular diagnostics and genomic services. The company is located in Aliso Viejo, California, and is rapidly expanding across multiple markets. We are seeking to hire a full time Bioinformatics Analyst to primarily analyze clinical sequencing data and help bioinformatics scientists to test bioinformatics pipeline.

Requirements:

Candidates should have a Bachelor or Master’s degree in Bioinformatics, Computer Science, Biology or a related field with practical experience analyzing sequencing data.

Preferred experiences:

• Work experience with Perl or Python, and VBA.
• Work experience with Linux/Unix system.
• Familiarity with SQL and PHP.
• Familiarity with the concepts of molecular biology and genomics.
• Practical experience in analyzing sequencing data, desirable next-gen sequencing.
• Motivated to work full time on sequencing projects using bioinformatics tools, and willing to learn new relevant skills.
• Ability to work both independently and in a team environment of a fast-moving genetic service company.
• Good oral and written communication skills.

Ambry Genetics offers a competitive salary commensurate with experience and qualifications. Benefits include health, dental, vision, 401K and 125c. Interested candidates should submit a letter of interest and curriculum vitae to xli@ambrygen.com.

Link for more information: http://www.ambrygen.com/Careers.html#Analyst

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Assay Validation Consultant
Posted by jobs November 22nd, 2011 .
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Hiring Company: Virapur

Job Code: 112211

Location: San Diego

Job Type: Validation

Compensation: $ TBD

Description: I am looking for someone to work directly with me in outlining a validation plan for an immunoassay. I need someone who has full knowledge of the issues with a typical biological assay and can guide me in writing the plan as well as the validation report. Some statistical knowledge pertinent to assay validation. The consultant should be able to put into words the validation assessment parameters that are pertinent to this assay. Limited project and short term effort which could be accomplished in part by email and phone.

Link for more information: http://www.virapur.com/assay_services/assay_services.php

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Quality Control Analyst
Posted by jobs November 18th, 2011 .
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Hiring Company: PaxVax, Inc.

Job Code: 2055

Location: Sorrento Valley

Job Type: Biotechnology

Compensation: $ DOE

Description: Specific Responsibilities:

• Perform assigned quality control testing, which may include, but is not limited to cell based titer assay, moisture analysis, disintegration, and PCR.

• Maintenance of mammalian cell cultures

•Qualification and validation of QC test methods.

• Writes and revises standard operating procedures and other related GLP/GMP documentation.

• Performance of data entry and trend analysis and ensures laboratory data integrity and traceability.

• Manages test samples, reagents and reference standards used in the laboratory.

• Develop and optimize QC test methods, as required.

• Reviews data obtained for compliance to specifications and reports abnormalities.

• Trains personnel on quality control methods and procedures
• Provides back-up assistance for other QC systems such as the Environmental program and raw materials.

Qualifications:

•Degree in Biology or Life Sciences related discipline with a minimum of three (3) years experience performing assays in a GMP-regulated environment.

• Possess a strong work ethic along with a solid organizational, time management, problem-solving, decision-making, judgment, and interpersonal skills.

• Demonstrate an ability to think and act independently; accept supervision, work quickly and accurately in a fast-paced environment, critically analyze data and proactively solve problems.

Background:

PaxVax is an innovative and fast-paced vaccine start-up company developing vaccine candidates against several important infectious diseases, including influenza, cholera and HIV. The Company’s first vaccine candidate for H5N1 or “bird flu” recently completed a successful Phase 1 clinical trial. In the coming year PaxVax plans to initiate three additional clinical trials on its candidates. The Company has committed funding of over million to support its operation including R&D and its own licensed GMP manufacturing facility. PaxVax has 45 employees organized by functional departments and cross-functional project teams for each of its vaccine candidates. PaxVax is a double bottom line business focused on delivering both financial as well as social returns in global health.

Benefits: Company sponsored employee medical and dental benefits, 401k, STD & LTD coverage. Competitive compensation. No relocation assistance is available.

PaxVax is an Equal Opportunity Employer.

Link for more information: http://www.paxvax.com

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Project Manager – Leader
Posted by jobs November 18th, 2011 .
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Hiring Company: PaxVax, Inc.

Job Code: 2056

Location: Sorrento Valley

Job Type: Biotechnology

Compensation: $ DOE

Description:

Summary of Position:

The Project Manager will be a key member of the Project Management team, reporting directly to the Vice President of Project Management and located at our San Diego site. The Project Manager will work closely with internal functional department heads (research, manufacturing, clinical) and external vendors and consultants (toxicology and regulatory) to oversee and direct the schedule and budget of candidate vaccine programs. The Project Manager will also assist the VP in the growth and development of project management systems for the company including project leadership and financial reporting and integration.

Primary Responsibilities:

o Develop and monitor project plans, resources, timelines and budgets to ensure alignment with corporate objectives

o Schedule, lead and facilitate project team meetings: prepare and issue agendas, presentations, minutes, action items; Communicate regularly with milestone champions to track milestone achievements and monitor key deliverables

o Facilitate and resolve any conflicts between functional departments amongst the senior executive team

o Work closely with CFO and finance department to develop and track project expenses, internal and external, FTE hours, and vendor billings and identify variances to budget and communicate issues that could impact that budget

o Analyze contracts (MTAs, CDAs, etc) and proposals and identify potential issues in advance and suggest measures to mitigate and/or manage risks

o Prepare and issue requests for proposals, schedule presentations as needed, and summarize proposals for executive team/VP.

o Keep executive team/VP informed of current and anticipated expenses of key contracts. May troubleshoot invoices and work with internal accounting staff and vendors to correct any problems

o May manage vendor relationship and expectations and builds a collaborative relationship with the vendor

o Review and write business correspondence

o Research potential funding sources to coincide with the funding focus of the company

o Manage the grant funding budget and accounting process as needed

Requirements:

o BS required, MS/Ph.D preferred

o Requires 5 years of successful project management experience in life science industry

o Expert knowledge of basic science and drug development functional areas: cellular assays, preclinical models of efficacy and toxicology, clinical and regulatory affairs, clinical operations, formulation and manufacturing. (Specific experience with biologics and/or vaccine experience is a plus)

o Ability to quickly assess problems/situations and provide effective resolution/solutions as well as proven success at team leadership, facilitation and conflict resolution

o In depth knowledge of Microsoft Project and Microsoft Project Server required

o Detail oriented and extremely organized; ability to prioritize multiple project deliverables

o Strong mathematical/financial skills, familiarity with project cost accounting, government contracts

o Ability to multi-task and prioritize efficiently across multiple projects/sub-projects

o Strong analytical and interpersonal skills, as well as the ability to motivate and influence; vendor interface experience and strong negotiating skills

o Excellent written and oral communication skills

o Ability to multitask and work both in a team environment as well as independently as required

o Ability to handle details of a highly confidential and critical nature

o Proficiency with Microsoft Office products, in particular Word, Excel, PowerPoint, Outlook and Visio

o Language skills a plus

Background:

PaxVax is an innovative and fast-paced vaccine start-up company developing vaccine candidates against several important infectious diseases, including influenza, cholera and HIV. The Company’s first vaccine candidate for H5N1 or “bird flu” recently completed a successful Phase 1 clinical trial. In the coming year PaxVax plans to initiate three additional clinical trials on its candidates. The Company has committed funding of over million to support its operation including R&D and its own licensed GMP manufacturing facility. PaxVax has 45 employees organized by functional departments and cross-functional project teams for each of its vaccine candidates. PaxVax is a double bottom line business focused on delivering both financial as well as social returns in global health.

Benefits: Company sponsored employee medical and dental benefits, 401k, STD & LTD coverage. Competitive compensation. No relocation assistance is available.

PaxVax is an Equal Opportunity Employer.

Link for more information: http://www.paxvax.com

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Research Associate – Cell Culture
Posted by jobs October 17th, 2011 .
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Hiring Company: Stemgent, Inc.

Location: San Diego, California

Job Type: Full-time

Description: The Research Associate – Cell Culture will execute functional cell-based assays, analyze data and interpret results.

Responsibilities include:

• Testing of raw material and finished goods per in-house procedures.

• Maintenance of mammalian cell lines, including monitoring cell density, viability and seeding cells at desired densities.

• Development and execution of cell-based assays for evaluating protein activity.

• Characterization of cells by immunocytochemistry and flow cytometry.

• Design, implementation and revision of standard operation procedures (SOP’s).

• Maintain accurate and up-to-date records and reports.

Requirements:

The candidate must be detail oriented, able to strictly adhere to methods/SOP’s, possess excellent documentation skills, and have at least two years of experience in a cell culture laboratory.

Outstanding work ethic, highly motivated, creative problem-solving, excellent communication skills, the ability to work well in a team setting, and flexibility are also required. A familiarity of GLP and industry standards pertaining to Quality Control procedures, documentation, and testing is desirable.

• A minimum of a Bachelor of Science degree with 2+ years cell culture experience, preferably in an industrial setting.

• Advanced laboratory skills, including knowledge of lab equipment such as a plate reader and fluorescent microscope.

• Experience with culture of multiple mammalian cell lines as well as with cell-based proliferation assays.

• Familiarity with characterizing cells by flow cytometry and/or immunofluorescence.

• Ability to design and execute experiments, analyze results, troubleshoot experiments, and formulate conclusions.

• Excellent organizational skills, including the ability to efficiently evaluate, prioritize, and handle multiple tasks.

• Proficiency in generating and promptly delivering project reports.

• Excellent communication skills, both written and verbal.

• Solid computer software skills including Microsoft Word, Excel and PowerPoint.

Stemgent, Inc. is engaged in working alongside some of the world’s leading stem cell scientists in developing innovative reprogramming technologies and stem cell solutions for the advancement of stem cell research. Our mission is to support the research community who use stem cells in a range of settings and applications by providing validated reagents, training and custom cell line services. By providing access to cutting-edge, reproducible products, researchers can focus on their experiments. Stemgent’s scientific development sites are located in both Cambridge, Massachusetts and San Diego, California. For more information on Stemgent, please visit: http://www.stemgent.com.