The ideal candidate will have demonstrated experience with tissue culture on multiple transformed cell lines and/or primary cells. He/she will select cell lines with the desired characteristics, maintain and propagate cell cultures, prepare cell blocks for immunohistochemistry controls and perform cell based assays, cell viability assays, ELISA, western blot, and IHC assays. He/she will clean, sterilize and maintain equipments in the cell culture facility. He/she will develop standard operating procedure for the growth and maintenance of cell lines. In addition, the candidate will maintain good record keeping in notebooks, manage the cell line inventory and database and monitor work to ensure utmost quality and adherence to GLP standards.
The candidate should possess excellent laboratory and data analysis skills, as well as organization, computer software and documentation skills, attention to details, ability to multi-task, excellent time management, and a strong work ethic. Prior experience with cell culture in a fast-paced, high-volume work environment is desirable.
Education: BS in a life science discipline. MS or PhD a plus.
Experience: 5+ years related experience in a laboratory research setting, industrial R&D group or equivalent. Teaching, service or support experiences a plus. Experience with DNA amplification methods, PCR and real PCR instrumentation and software, protein purification and analysis applications and methods, lab and/or process scale chromatography, or laboratory imaging desired.
Skills: Strong written and verbal communication skills. Expertise in problem-solving, data analysis and troubleshooting instrument and experimental problems. Aptitude for computer hardware and software. Customer service and team player. Ability to act independently of supervision.
Requirements:
• Ph.D. in Pharmaceutical Sciences or relevant discipline, with 2 to 5 years of post-doctoral experience in protein formulation, preferably in an industrial setting. Candidates without PhDs but commensurate industrial experience will also be considered.
• Solid knowledge in protein biochemistry and analytical chemistry is essential. Strong hands-on experience with analytical instrumentation (HPLC, electrophoresis) and protein characterization techniques (mass spectrometry, DSC, fluorescence) is critical.
• A demonstrated track record in liquid formulation development for proteins is necessary. Knowledge in lyophilized formulation development is desirable but not essential.
• Current knowledge with IP issues and industry practice/regulatory guidelines on protein formulation and is essential.
• Enthusiasm, willingness to learn, strong work ethic, broad scientific interests and ability to work on multiple projects simultaneously.
• Excellent organizational skills are required, along with demonstrated initiative-taking and innovative thinking within a team environment.
• Excellent interpersonal and communication skills along with the willingness to collaborate within and outside of the team.
• Embrace our core values: Challenge ourselves to excel; Seek and act to achieve the best outcome; Make and keep commitments; Create extraordinary experiences.
Responsibilities (include but are not limited to):
• Assume ownership of a significant portion of the data set-up effort, by retrieving, merging, and cleaning large datasets.
• Play a leading role in conducting exploratory data analysis.
• Support executives and managers in a consultative way throughout ongoing investigations.
• Perform detailed literature review and write up for current projects.
• Communicate effectively with senior management regarding research methodology.
• Help the team by providing unique insights on the data, and evaluate trends as well as emerging themes in data.
Technical Skills & Qualifications:
• Undergraduate degree required; possessing or currently pursuing an advanced degree in psychology, public health, epidemiology, or behavioral statistics preferred.
• Proficiency in using SPSS and SPSS Syntax, conducting data cleaning, and exploratory data analysis on large 100,000 + samples; capable of querying and analyzing complex quantitative and qualitative data sets.
• Proficiency with introductory statistics, as well as some experience with multivariate, multi-level, and forecasting models (e.g. HLM, SEM, ARIMA).
• Some working experience with HLM, AMOS, PASW Forecasting is desired.
• Demonstrated skills using Microsoft Office Suite (Excel/ Word/ PowerPoint).
• Outstanding literature review and writing skills; ability to clearly synthesize, discuss and write about complex concepts in the research literature.
Non-technical Skills & Qualifications:
• Strong analytical thinker, capable of breaking down and working with broad research hypotheses.
• Well-developed problem-solving ability and critical thinking skills.
• Comfort engaging with senior-level administrators.
• Strong interpersonal communication skills.
• Ability to work independently, but also as a member of a team.
• Desire to collaborate with other departments to gather and document requirements and to learn all aspects of program functionality.
If interested please send a cover letter and your CV clearly outlining how your skills and experience meet the requirements of this position. You should also include a writing sample demonstrating literature review, writing and research abilities. Please no phone calls.
This is a strategic and tactical Product Manager Position. Candidate must be savvy in both reagents and capital equipment, however more focus is on the instrumentation.
We are looking for a real team player with the highest integrity; someone who is looking for a career/ long term position.
We prefer at least 4-5 years of industry specific experience in addition to an MBA. We can only consider candidates who have biotech/biopharm experience.
Essential Duties and Job Functions:
Must meet all requirements for Principal Clinical Research Associate position and have demonstrated proficiency in all relevant areas. Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines. Responsible for development and monitoring of study budgets and timelines. Partners with functional peers to manage, adjust, and revise project timelines/budgets as necessary. Develops RFPs, select CROs/vendors, and manages external resources. Communicates project status and issues and ensure project team goals are met. Participates in development of SOPs, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory, safety documents. Contributes to development of abstracts, presentations, and manuscripts. Recruit, hire, mentor, and manage CPA/CRA direct reports and support their professional development. Participate in training of CPAs and Crass. Successfully develops, implements, and completes clinical trials. Manages designated program budget and timelines. May determine activities critical to company success and priorities within functional area. Anticipates moderately complex obstacles and client difficulties and implements solutions to achieve project goals. May design and use all available vehicles for scientific communication within company. With limited supervision may participate in or lead departmental strategic initiatives. Travel is required.
Knowledge, Experience, and Skills:
Typically requires a BS or BA in a relevant scientific discipline and minimum 8 years relevant clinical experience in the pharmaceutical industry or equivalent. Excellent interpersonal skills, and demonstrated ability to lead is required. Experience in managing staff as well as mentoring and developing junior staff is required. Strong communication and influence skills and ability to create a clear sense of direction is necessary. Must be able to resolve problems using national and international regulations, guidelines, and investigator ineration. Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials. Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required. Experience in developing RFPs and selection and management of CROs/vendors. Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, DNA, etc.) with little supervision. Ability to examine functional issues from a broader organizational perspective. Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision. Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.
We are seeking a creative, self-motivated and entrepreneurial minded individual to provide installation and continuing customer service to our client base.
You must have a technical background in environmental services, waste water treatment, electronics or a related discipline, with 1-3+ years experience, preferably in the field installation area. Excellent communication, interpersonal, and computer skills (including proficiency in Word, Excel, and Outlook) are required. Hands-on experience with electronic instrumentation in adverse environments, working knowledge of wireless systems, ability to perform low level electrical and software functional testing, and a basic understanding of systems containing embedded processors is highly desirable. The ability to travel both local and long distances within the United States is required.
Initially you will
• Perform the on-site installation and maintenance of our remote monitoring systems at sites throughout the United States.
• Assist in analysis of field data.
As the company grows you will
• Work with a team that manages remote installation of our systems and continuing customer support.
• Interface with other team members to rapidly grow the company to over 100,000 installations throughout the country and abroad.
Permanent Resident status required; reimbursement of relocation expenses is not available.
Travel is required. Must have valid driver’s license, good driving record and be able to rent vehicles. Must be capable of lifting 75-100 lbs.
SepSensor is a drug free workplace; must pass a pre-employment drug screen
SepSensor is located near the intersection of Interstates 495 and 290.
Email resume including “Field Technician - Customer Service” in subject line and your salary requirements to: cmccarthy@sepsensor.com
• Participate in the direction, planning, execution and interpretation of the clinical research project through site management and communications both in-house and in the field.
• Assure successful conduct of assigned clinical study sites consistent with applicable regulations, guidelines and policies.
• Assist in ensuring adequate monitoring of study (for example, helping to assure that CRO accomplishes all tasks, that resolution of all issues noted by monitors are documented and appropriate and that corrective and/or preventative action is taken to avoid recurrence as necessary.)
• Create and maintain tools to report and measure study progress. Assist with contractor management and QA especially of monitoring and study management, but also of other area contractors (SMO’s, IVRS, etc.).
Qualifications:
• Requires a strong knowledge of clinical research study design, GCP and regulatory compliance guidelines for clinical trials combined with strong prioritization, organizational and problem solving skills.
• Exhibit attention to detail.
• Extremely accurate and have strong interpersonal communication skills.
• Excellent computer skills including Word, Excel and Power Point.
• Since site visits will be required, must be able to travel 30%.