Overview
We are seeking a Biologist to support the National Institutes of Healths (NIH) world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Gaithersburg MD. Our NIAID professional technical and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference.
CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality cost-effective programs and research management services. We combine our proven systems with todays most effective evidence-based best practices. Our core practice areas include: clinical research; vaccine research microbiology and infectious disease research development and production; biodefense; global health security; and HIV/AIDS programs.
Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS you will notably improve the lives of people at home and abroad.
Responsibilities
- Develop downstream (purification) processes under the supervision of a project lead scientist for recombinant proteins virus vaccines and virus-like particles (VLP) that may be used as clinical candidates.
- Design and execute mRNA-Lipid Nanoparticle (LNP) process development studies for mRNA-lipid nanoparticle encapsulation.
- Serve as SME with operation and optimization of microfluidic systems e.g. Precision NanoSystem Inc Ignite and Blaze and/or Knauer NanoScaler Impingement Jet Mixers.
- Develop scale down and scale-up operations to advance tech transfer to manufacturing and/or enable troubleshooting.
- Screen and optimize tangential flow filtration processes for mRNA-LNP products to generate preclinical materials and drive tech transfer for clinical manufacturing.
- Design and execute lipid screening studies to evaluate novel lipid components and formulations for use in pre-clinical safety and efficacy studies.
- Collaborate with analytical and formulation scientist to characterize mRNA-LNP formulations and optimize process flows and sample stability.
- Perform in vitro transcription reactions to generate mRNA products.
- Purify research-phase recombinant proteins virus vaccines and/or virus-like particles in collaboration with other groups or external collaborators.
- Work within the purification group to design develop and optimize chromatography and filtration step unit operations to drive process development of clinical trial vaccine candidates and mAb products.
- Collaborate with project management to ensure mRNA-LNP development milestones and study deliverables are met in a timely manner.
- Work to prepare necessary materials (buffers packed columns etc.) for execution of downstream process activities.
- Perform technology transfer of processes to VRC Pilot Plant for manufacture of clinical product through document generation and on-site support.
- Write and review tech transfer documents technical protocols and reports.
- Generate supporting documents as necessary for IND-filings and other regulatory needs.
- Analyze and compile data present at various group/department meetings.
- Performs other duties as assigned.
Qualifications
- Bachelors degree in Bioengineering Chemical Engineering Biochemistry or a related discipline.
- 5-7 years of experience in recombinant protein purification and mRNA-LNP development for GMP clinical-phase products.
- Demonstrated knowledge of maintaining accurate and detailed records.
- Must be a team player who can effectively work with members from cross-functional departments.
- Strong oral and written communication skills.
- Familiarity with computer software including word processing and data evaluation.
Physical Requirements:
The physical requirements described here are representative of those that must be met by a candidate to perform the essential functions of this job. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential job functions.
- Ability to lift or carry less than 25 pounds push or pull less than 25 pounds push or pull 25 45 pounds reach above shoulder level and use both hands.
- Will be required to stand or walk more than 25 of 30 min. bend repeatedly and climb.
- Must have depth perception have correctable near vision ability to distinguish basic colors and perform repetitive activities.
- Ability to work alone and closely with others work on ladders or scaffolding work around machinery with moving parts work with hands in water and work with solvents.
- Will be required to be in contact with laser in instrument.
- Will work with corrosive substances inorganic dust and powders heavy metals plastics solvents and sensitizing agents.
- Must be able to wear personal protective equipment (PPE) including gloves face shields/goggles safety glasses safety shoes lab coat clean room uniform and disposable dust/surgical mask.
Please submit your resume online at . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin age protected veteran status disability status or any other characteristic protected by any applicable federal state or local law.
CAMRIS offers a comprehensive benefits package including medical dental and vision insurance for individuals and families FSAs HSA life and AD&D insurance short- and long-term disability legal services voluntary hospital indemnity critical illness and accident insurances EAP pet insurance 401(k) with employer match and Roth option tuition and professional reimbursement public transportation support in the DMV area a referral bonus program vacation with tenure-based increases PTO 11 paid holidays paid bonding leave and paid supplemental short-term disability.
Employment is contingent upon successful completion of a Public Trust-level background check a requirement for this position under an active federal contract. The background check process may include but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.
Required Experience:
IC
OverviewWe are seeking a Biologist to support the National Institutes of Healths (NIH) world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Gaithersburg MD. Our NIAID professional technical and scientific support personnel are part of a preeminent team focused on positivel...
Overview
We are seeking a Biologist to support the National Institutes of Healths (NIH) world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Gaithersburg MD. Our NIAID professional technical and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference.
CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality cost-effective programs and research management services. We combine our proven systems with todays most effective evidence-based best practices. Our core practice areas include: clinical research; vaccine research microbiology and infectious disease research development and production; biodefense; global health security; and HIV/AIDS programs.
Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS you will notably improve the lives of people at home and abroad.
Responsibilities
- Develop downstream (purification) processes under the supervision of a project lead scientist for recombinant proteins virus vaccines and virus-like particles (VLP) that may be used as clinical candidates.
- Design and execute mRNA-Lipid Nanoparticle (LNP) process development studies for mRNA-lipid nanoparticle encapsulation.
- Serve as SME with operation and optimization of microfluidic systems e.g. Precision NanoSystem Inc Ignite and Blaze and/or Knauer NanoScaler Impingement Jet Mixers.
- Develop scale down and scale-up operations to advance tech transfer to manufacturing and/or enable troubleshooting.
- Screen and optimize tangential flow filtration processes for mRNA-LNP products to generate preclinical materials and drive tech transfer for clinical manufacturing.
- Design and execute lipid screening studies to evaluate novel lipid components and formulations for use in pre-clinical safety and efficacy studies.
- Collaborate with analytical and formulation scientist to characterize mRNA-LNP formulations and optimize process flows and sample stability.
- Perform in vitro transcription reactions to generate mRNA products.
- Purify research-phase recombinant proteins virus vaccines and/or virus-like particles in collaboration with other groups or external collaborators.
- Work within the purification group to design develop and optimize chromatography and filtration step unit operations to drive process development of clinical trial vaccine candidates and mAb products.
- Collaborate with project management to ensure mRNA-LNP development milestones and study deliverables are met in a timely manner.
- Work to prepare necessary materials (buffers packed columns etc.) for execution of downstream process activities.
- Perform technology transfer of processes to VRC Pilot Plant for manufacture of clinical product through document generation and on-site support.
- Write and review tech transfer documents technical protocols and reports.
- Generate supporting documents as necessary for IND-filings and other regulatory needs.
- Analyze and compile data present at various group/department meetings.
- Performs other duties as assigned.
Qualifications
- Bachelors degree in Bioengineering Chemical Engineering Biochemistry or a related discipline.
- 5-7 years of experience in recombinant protein purification and mRNA-LNP development for GMP clinical-phase products.
- Demonstrated knowledge of maintaining accurate and detailed records.
- Must be a team player who can effectively work with members from cross-functional departments.
- Strong oral and written communication skills.
- Familiarity with computer software including word processing and data evaluation.
Physical Requirements:
The physical requirements described here are representative of those that must be met by a candidate to perform the essential functions of this job. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential job functions.
- Ability to lift or carry less than 25 pounds push or pull less than 25 pounds push or pull 25 45 pounds reach above shoulder level and use both hands.
- Will be required to stand or walk more than 25 of 30 min. bend repeatedly and climb.
- Must have depth perception have correctable near vision ability to distinguish basic colors and perform repetitive activities.
- Ability to work alone and closely with others work on ladders or scaffolding work around machinery with moving parts work with hands in water and work with solvents.
- Will be required to be in contact with laser in instrument.
- Will work with corrosive substances inorganic dust and powders heavy metals plastics solvents and sensitizing agents.
- Must be able to wear personal protective equipment (PPE) including gloves face shields/goggles safety glasses safety shoes lab coat clean room uniform and disposable dust/surgical mask.
Please submit your resume online at . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin age protected veteran status disability status or any other characteristic protected by any applicable federal state or local law.
CAMRIS offers a comprehensive benefits package including medical dental and vision insurance for individuals and families FSAs HSA life and AD&D insurance short- and long-term disability legal services voluntary hospital indemnity critical illness and accident insurances EAP pet insurance 401(k) with employer match and Roth option tuition and professional reimbursement public transportation support in the DMV area a referral bonus program vacation with tenure-based increases PTO 11 paid holidays paid bonding leave and paid supplemental short-term disability.
Employment is contingent upon successful completion of a Public Trust-level background check a requirement for this position under an active federal contract. The background check process may include but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.
Required Experience:
IC
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