Posted today
Job id: a1Wcv0000007lS1EAI
DHVI Scientist I
Durham, North Carolina
Clinical Research & Trials
Contract
Medasource
-$40/hr
-k
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Job Description:
Occupational Summary
The Scientist I will support the development, qualification and execution of analytical methods to enable optimization of processes, formulations and characterization of vaccine products. This incumbent in this position will be involved in all aspects of pharmaceutical and analytical development for GMP production of vaccine products and therapeutics.
Work Performed
Lead pharmaceutical development and successful GMP release including:
- Analytical development: Develop product-specific release and characterization methods
- Qualify methods for product release and complete comprehensive characterization of clinical lots
- Complete GMP testing in line with ICH and regulatory guidance
- Formulation development: Develop formulations to stabilize vaccine products
- Employ analytical characterization tools to inform product formulation design
- Lead formulation & filling of vaccine products including tech transfer and production under GMP conditions
- Execute and document development and GMP activities in compliance with regulatory requirements
- Lead collaboration with other development teams to provide support for development activities and work diligently with cell line development and analytical development functions to understand how the process impacts product quality
- Analyze and interpret data and results of individual and team work, utilizing the data in appropriate decision making; summarize data and present results
- Lead writing and review of technical development reports; write and review protocols for tech transfer and SOPs for GMP production, and present data to project teams and larger settings
- Identify and document innovations including patenting and publishing of scientific results
- May mentor and develop junior staff
Required Qualifications at this Level
Education/Training:
Bachelor’s degree in a science, engineering, or related field. An advanced degree (Master’s, PhD) is preferred.
Experience:
6 years relevant experience in the biopharmaceutical industry or equivalent.
Skills:
- Experience in development of analytical methods and/or product formulations
- Demonstrates innovation in development of diverse analytical methods (HPLC, immunoassays, biochemical methods), molecular or pharmaceutical product formulation (buffer & excipient screening, thermal stability evaluation, biophysical methods) is required. GMP experience is preferred.
- Must work independently to develop specific processes or methods in line with strategic program goals.
- Demonstrated advanced ability in solving complex analytical problems in alignment with strategic project plans.
- Strong oral and written communication skills.
Disclaimer: Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.
EEO:
We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.
Benefits & Perks:
Eight Eleven Group offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
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Your need for talent is our reason for being. This driving mission has been at our core from the onset. When we started in 2000 at 811 Broad Ripple Avenue, we were a team of forward-thinking entrepreneurs determined to find a better way to connect the best and brightest talent with companies looking for future leaders. We still believe in this philosophy. Throughout the years, our passion, credibility, and grit have been the foundation and prowess of what is now Eight Eleven. Though our focus areas have continued to mindfully evolve, our unyielding commitment to relationships and our customers’ needs remain consistent and firmly rooted in our core values.