We are seeking a
Scientist who 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.
- 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.
- Operating knowledge of suitable computer software packages.
- 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. Collaborate with scientists within
pre-clinical and other departments, and may also participate in key
project teams.
- The ability to handle multiple projects simultaneously and work in a fast-paced environment.
- Demonstrated experience (2 years minimum) interacting/managing extramural programs at Contract Research Organizations.
- Familiarity with GLPs is desirable.
- Review CMO issued batch records, PDR and process deviation reports
- Write QA/QC certified protocols and reports
* A BA/BS or MS in Biological Sciences and 8-10 years of experience in a bioanalytical/analytical laboratory
* PhD in Biological Sciences and 5-8 years of experience in a bioanalytical/analytical laboratory
*
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.
* Ability to write clear, concise technical reports and attention to detail is essential.
* Demonstrated experience managing extramural programs at Contract Research Organizations.
* A record of publications in peer reviewed journals.
* Experience in a broad range of immunology- and biochemistry-based assays as well as small molecule bioanalytical methods.
For immediate and confidential consideration, please email your resume to info@simplybiotech.com or call 858.487.0507.
More information can be found at www.simplybiotech.com.
EOE
* Dose animals by subcutaneous, oral gavage, intraperitoneal and /or intravenous administration.
The qualified Research Associate II will possess:
* BS with a concentration in pharmacology, neurobiology or related field
• Build the laboratory team
• Provide direct supervision of high complexity testing personnel
• Responsible
for implementing and maintaining a Quality Management System (QMS), for
all phases of testing, to include the pre-analytic, analytic, and
post-analytic phases of testing as well as general laboratory systems.
• Verify
test systems have established acceptable performance specifications for
the performance characteristics of accuracy, precision, analytical
sensitivity, and analytical specificity.
• Establish a robust
program for troubleshooting, maintenance and calibration of
instrumentation and equipment used to perform the testing.
• Establish
and maintain an approved Proficiency Testing (PT) program to include an
approved corrective action plan when any PT results are determined to
be unacceptable.
• Establish and maintain quality control and quality assessment programs.
• Establish
and maintain an approved procedure manual and ensure it is available to
all personnel responsible for any aspect of the testing process.
• Establish
policies and procedures for hiring and monitoring testing personnel to
ensure they have the appropriate education and experience, receive the
appropriate training and are competent to perform the testing
procedures.
• Evaluate test results for completeness, accuracy and quality.
• Report test results to clients.
• The requirements for Technical Supervisor under CLIA regulations (42 CFR, part 493).
• A minimum of 7 years related experience.
• Experience in a high complexity CLIA/CAP environment strongly preferred.
• Knowledge of molecular biology or medical genetics preferred.
• Experience with DNA sequencing, PCR, microarrays, robotics and LIMS systems is a plus.
More information can be found at www.simplybiotech.com.
EOE
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
-
Interact with R & D scientists during early purification
development cycle and identify 3-4 key chromatography steps necessary
to purify the recombinant protein to >95% homogeneity
- Provide
leadership and guidance in the design of robust downstream processes
for purification of enzymes for potential transfer to GMP environment
- Supervise the research of other scientists as needed to accomplish project goals in a timely manner
- Provide high quality data on the biochemical and biophysical properties of therapeutic enzyme candidates
- Report results to multidisciplinary research project teams and support company's goals, objectives and priorities
-
Assist in the scientific and career development of associate scientific
staff. Provide input into overall research priorities and manpower
needs
- Experience with new fast-flow and high-capacity
chromatography resins (Material Master File Certified) for purification
of recombinant proteins
- Interface with resin manufacturers to survey new resins as they become available
- Generation of batch records and oversee tech transfer operations at CMO
-
Conduct on-site visits of CMO and oversee technology transfer
activities - Maintain laboratory note books and manage computer files
- Participate in project meetings and provide feed back on experimental work completed
-
Comply with established company policies and procedures, objectives,
quality assurance programs and other environmental standards
- Train junior staff in analytical and protein purification methods
- Train, upgrade and maintain laboratory equipment as needed
- Review CMO issued batch records, PDR and process deviation reports
- Write QA/QC certified protocols and reports
The qualified Scientist will possess:
* A Ph.D in biochemistry , chemical engineering or related
* Experience in downstream process development as it relates to protein recovery and purification
* Prior experience in chromatography procedures to remove product related impurities
*
Knowledge of: Column Chromatography experience is essential.
Experience with common laboratory equipment: Akta, FPLC, HPLC,
Spectrophotometer, and Gel Electrophoresis equipment is required.
* The ability to travel up to 25% of the time
More information can be found at www.simplybiotech.com.
EOE
* Prepare all study binders prior to Study Initiation.
* Prepare drug shipment requests for study drug shipments from vendors to study sites.
* Verify of study drug accountability completeness at site visits.
* Ensure case report forms (CRFs) are accurate, complete, and verifiable against source documents.
* Verify study site screening and enrollment logs are complete and current.
* Participate in collection of data relative to serious adverse events.
* Ensure site compliance with the protocol, CRFs, GCP's, resolution of data queries, and overall clinical objectives.
* Track
clinical data, regulatory documents, patient enrollment, and data
resolutions to assist the timely completion of clinical studies.
* Assist in the creation of model informed consents, case report forms, instruction manuals, and monitoring tools.
* Assure regulatory compliance of investigational sites with company SOP's, FDA, and ICH guidelines.
* Write visit reports and follow-up letters to investigators.
* Set up files, archive study documentation, correspondence and completed case report forms.
The qualified CRA II will possess:
* Bachelor's degree in a clinical or health related field, in life sciences or equivalent qualifications. Prefer RN or BSN.
* 3+ years prior experience in monitoring and managing clinical sites.
* The ability to travel up to 30% of the time
More information can be found at www.simplybiotech.com.
EOE
We are seeking a Medical Director of
Clinical Development & Medical Affairs who will be responsible for
the safety and medical monitoring activities of multiple clinical
trials, and will also participate in the development and authorship of
clinical trial protocols, data analyses, clinical study reports, and
other clinical documents. The position may involve both pre-marketing
and post-marketing clinical trials.
-ensuring that all company clinical trials
are conducted according to GCP and all applicable regulatory
requirements, with a focus on the safety and medical monitoring aspects
of the trials;
-working in collaboration with clinical operations
personnel who will provide complementary oversight of clinical trials
with regard to operational aspects;
-being the company's first point
of contact for the investigational study sites with regard to questions
about patient eligibility in trials, protocol waivers, safety issues,
regular review of safety parameters and generation of periodic safety
reports, and the receipt and processing of SAEs, including authorship
of narratives for SAEs and participation in IND expedited safety
reports;
-playing a role in post-marketing pharmacovigilance,
working in conjunction with the company's marketed drugs call center
and receiving and processing post-marketing ADR reports, including the
generation of narrative and completion of MedWatch forms and the
authorship of Periodic Safety Update Reports; and
-performing other duties as assigned.
The qualified Medical Director / VP will possess:
* MD degree
* Minimum of 5 years of clinical practice patient care experience
* Board Certification (BE/BC) preferred, ideally in oncology
*
Excellent working knowledge of FDA regulations and expectations, Good
Clinical Practice, ICH guidelines, and clinical drug development
* Intimate knowledge of and high level expertise in the day-to-day medical monitoring of pre-marketing clinical trials
* Demonstrated experience and expertise in the primary authorship of multiple clinical trial protocols
* Demonstrated experience and expertise in the primary authorship of summaries of data from clinical trials
*
Demonstrated experience and expertise in the primary authorship of
clinical study reports, including oversight of the generation of
tables, figures and listings from the study database, preferred
More information can be found at www.simplybiotech.com.
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The qualified Sr. Quality Engineer will possess the following:
* BS in Engineering
* 3-5+ years medical device engineering experience
More information can be found at www.simplybiotech.com.
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* BS in Mechanical Engineering or Biomedical Engineering
* Knowledge of QSR, GLP, and relevant medical standards
More information can be found at www.simplybiotech.com.
EOE
The qualified Clinical Lab Technician II will possess the following:
* High School Diploma / GED and 3+ years of experience
* BS in a scientific field and 6+ months experience working in a CLIA/CAP environment
* Microsoft office skills strongly preferred
* California Phlebotomy certificate strongly preferred
More information can be found at www.simplybiotech.com.
EOE
We are currently seeking a
Pharmaceutical Chemist for a rapidly growing company. In this role, the
qualified candidate will conduct preformulation testing, formulation
development, stability testing, and methods development on chemistry
related studies to advance the development of drug candidates.
- Perform ongoing stability testing for methods
- Conduct preformulation studies to support future formulation efforts
- Work with supervisor to develop potential formulations
- Exercise technical discretion in the design, execution and interpretation of experiments
- Participate in meetings, conference calls, and other interactions with clients
- Prepare reports, summaries, protocols, batch records, and quantitative analysis
- Maintain a high level of professional expertise through familiarity with scientific literature
- Follow and prepare necessary SOPs
The qualified Pharmaceutical Chemist will possess:
* BS/BA science degree
* Excellent communication skills (you will be interacting with clients regularly)
* 5 years experience with:
-
HPLC, dissolution, and general wet chemistry experience such as: method
development, reversed-phase chromatography, ion-exchange
chromatography, UV/Vis spectroscopy, and Karl Fisher analysis.
-
Current analytical methodology experience and knowledge of GLP and GMP
regulations such as: method qualification, test method preparation,
product specification development for pharmaceutical products.
-
Preferably, preformulation and formulation development experience such
as: preformulation analysis of small molecules or peptides, oral
formulation development, and injectable formulation development.
For immediate and confidential consideration, please email your resume to info@simplybiotech.com or call 858.487.0507.
More information can be found at www.simplybiotech.com.
EOE
* Coordinate and execute release testing on all phases
* Perform ongoing GMP stability testing
* Validate, qualify and transfer analytical methods
* Coordinate testing with third party vendors
* Interpret and trend stability data
Follow and prepare necessary SOPs
Lead a team (conference calls, meeting, etc)
BS/BA in Life Science
Quality Control Experience (3+ years)
* Proven leadership ability (1-2 years)
Excellent laboratory protocol
* Outstanding oral and written communication
HPLC,
dissolution, and general wet chemistry experience, including: method
development, reversed-phase chromatography, ion-exchange
chromatography, UV/Vis spectroscopy, and Karl Fisher analysis.
Current
analytical methodology experience and knowledge of GLP and GMP
regulations, including: method validation, test method preparation,
product specification development for pharmaceutical products
For immediate and confidential consideration, please email your resume to info@simplybiotech.com or call 858.487.0507.
More information can be found at www.simplybiotech.com.
EOE
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