Location: Silver Spring, MD
Company: Kikiktagruk Inupiat
Oak (WO).
OPQ is an umbrella organization overseeing the activities of the Chemistry, Manufacturing, and Controls (CMC) review process and drug testing and scientific evaluation of drug products in support of the regulatory components of FDA. This includes backssment of product and process designed, evaluation of product quality in light of established standards and setting and maintaining new quality standards.
DPQR conducts regulatory research on continuous manufacturing as part of an interdisciplinary research approach to address emerging product quality issues. DPQR is doing research on continuous drug substance manufacturing to address regulatory challenges faced by the Agency
for this innovative technology. Duties/Responsibilities: Collaborates with DPQR staff to identify appropriate PAT equipment and methods based on expertise to advance product quality research goals including writing research proposals and protocols Collaborates with DPQR staff to identify prospective applications for PAT implementation, model development, and validation Develops and validates PAT models to predict manufacturing process performance and/or product quality attributes Documents and communicates research results generated from studies including writing technical reports and scientific papers, as well as delivering oral and poster presentations Works with DPQR management to coordinate
activities for the PAT group within DPQR Works with DPQR management to establish collaborations with other PAT groups within the FDA Works with DPQR management to establish collaborations with external stakeholders on advancing the utilization of PAT in medical development and manufacturing Develops training materials and courses on PAT applied to medical development and manufacturing Develops white papers on emerging topics in PAT for medical development and manufacturing Routinely updates management on the status and progress of the PAT-related research projects Minimum Requirements: Requires a bachelor's degree or higher in a science or engineering discipline (e.
g. chemical/mechanical engineering) Minimum four (4) years of experience in applying PAT to address scientific questions. Industrial or government experience applying PAT for processes and/or physical systems. Knowledge and hands-on experience with PAT instruments that can be applied to medical manufacturing including unit operations that involve particles, flowing powders, solutions, and suspensions (e. g. near infrared, Fourier transform infrared, and Raman spectroscopy, etc. ). Knowledge of chemometrics, multivariate modeling approaches, and data processing methods that can be applied to large data sets (e.
g. principal component analysis, partial least squares analysis, linear discriminant analysis, etc. ). Knowledge and hands-on experience with a range of software platforms used for multivariate analysis (e. g. Unscrambler, SIMCA, MATLAB, Eigenvector, Python, etc. ) and willingness to learn platforms as needed. Knowledge of PAT model development, verification, and validation practices. Attention to Detail - being thorough when planning, developing, and carrying out vital tasks in supporting research projects including PAT method documentation. Customer Service - assisting others in the resolution of issues when integrating PAT, developing models, or interpreting results.
Collaboration - willing to participate in interdisciplinary projects working with members and managers on product quality research projects and initiatives. Written Communication - expressing highly technical information (e. g. ideas or facts) to individuals or groups effectively, taking into account the audience and nature of the information, including scientific publications. Oral Communication - expressing highly technical information (e. g. ideas or facts) to individuals or groups effectively, taking into account the audience and nature of the information.
Problem Solving - conducting extensive investigation and analysis to determine the nature and scope of problems and devise solutions. Working knowledge of medical development and manufacturing is a plus. Apply online at our website: kikiktagruk. / Disclaimer: This is not to be an exclusive list of all responsibilities', duties, and skills required of the person in this job. KIC is an Equal Opportunity Employer. KIC considers all applicants for employment without regard to race, color, interaction, national origin, religion, age, physical or mental disability, family responsibility, marital status, interactionual orientation, political affiliation, veteran's status or any other legal protected status.
Pursuant to The Alaska Native Claims Settlement Act 43 U. S. C. Sec. 1601 et seq. and federal contractual requirements, Kikiktagruk Inupiat Corporation, may legally grant certain preference in employment opportunities to KIC Shareholders and their Descendants. EOE/AA/M/F/D/V. Please view Equal Employment Opportunity Posters provided by OFCCP here. Successful candidate must pass, comply and adhere to KIC's Drug and Alcohol policy/testing requirements and pass a thorough background check including fingerprinting.
characterize drug induced changes in cell proteomics and immuno-proteomics. RESPONSIBILITIES: Develop and validate chromatographic and mass spectrometry-based assays for immuneproteomics of HLA presented peptides and small molecules. Produce reports for reliable, sensitive, and validated immunological methods of analyses (prepares, edit, and designate project reports) Perform analysis of mass spectrometry data in order to identify sequences of peptides and modifications using software including PEAKS.
Preparation of standard operating procedures (SOP) and protocols for method validation of immunological assays. Ensure that all work is in compliance with all pertinent SOPs and safe work
practices. Other duties as assigned. MINIMUM REQUIREMENTS: PD in Life Health and Medical Sciences, Biochemistry or any other related field with 2+ years of laboratory experience with immunology and biochemistry and the ability to work independently.
MS in Life Health and Medical Sciences, Biochemistry or any other related field with 5+ years of laboratory experience with immunology and biochemistry and the ability to work independently. Experience in developing and validating analyses of immune biologics and proteins by LCMS. Experience in isolating HLA molecules, affinity purifying peptides from HLA and then performing immune-proteomics using LCMS to characterize the peptides. Basic
office software skills (Word, Excel, Powerpoint, Sigmaplot, Access or File Maker Pro databases etc.
) are required and basic statistical data analysis skills are highly desired. Experience in Mass spectrometry software PEAKS for data analysis. If interested, please apply at kikiktagruk. / Disclaimer: This is not to be an exclusive list of all responsibilities', duties, and skills required of the person in this job. KIC is an Equal Opportunity Employer. KIC considers all applicants for employment without regard to race, color, interaction, national origin, religion, age, physical or mental disability, family responsibility, marital status, interactionual orientation, political affiliation, veteran's status or any other legal protected status.
Pursuant to The Alaska Native Claims Settlement Act 43 U. S. C. Sec. 1601 et seq. and federal contractual requirements, Kikiktagruk Inupiat Corporation, may legally grant certain preference in employment opportunities to KIC Shareholders and their Descendants. EOE/AA/M/F/D/V
strains continue to emerge and spread rapidly worldwide. This poses challenges to diagnosing infected individuals and developing new vaccines and therapies. Therefore, it is imperative that the Food and Drug Administration (FDA) determine if newly developed tests for screening the blood supply can accurately detect all the existing and emerging HIV strains in blood samples.
One of our ongoing studies is that HIV virus panel study will help FDA in its global collaborations aimed at ensuring there are accurate HIV diagnostic tests and safe and effective vaccines available to respond to the changing population of AIDS viruses. HIV virus panel study will provide new insights and will support
development of improved diagnosis, disease monitoring, drug design, and vaccines. OBRR has also helped to produce a new FDA document that offers guidance to blood donor facilities in identifying donors at increased risk for being infected with the variety of HIV-1 called " group O.
" This will help to screen out donors who might be infected based on having spent time in certain parts of Africa or having received blood transfusions or engaged in interactionual activity with residents or former residents in those areas. Duties/Responsibilities: Extract and purify HIV RNA from cultured virus, perform reverse transcript HIV RNA to c DNA, use established primer pool and multiple
PCR methods to amplify the c DNA for Sanger or NGS Sequencing analysis.
Develop new methods and optimize the new systems to amplify highly diversify HIV-1 strains for whole genomic sequence. Sanger and NGS sequencing the PCR products from task 1 and 2. Initial the bioinformatics analysis to determine whole length HIV-1 genomic contigus, identify the genotype and HIV Circulating Recombinant Forms (CRFs). Prepare the aliquoted isolates to delivery to collaborators for Viral Load (VL) test and RNASeq studies. Minimum Requirements: A Ph D or Master degree in any branch of Life Science Research experience in virology or molecular biology area (HIV preferred). Training in the safe handling of human blood samples Experience in Biosafety Level 2 plus and Level 3 laboratories Experience with analysis of human genome data and HIV sequencing data preferred.
Apply online at our website: kikiktagruk. / Disclaimer: This is not to be an exclusive list of all responsibilities', duties, and skills required of the person in this job. KIC is an Equal Opportunity Employer. KIC considers all applicants for employment without regard to race, color, interaction, national origin, religion, age, physical or mental disability, family responsibility, marital status, interactionual orientation, political affiliation, veteran's status or any other legal protected status.
Pursuant to The Alaska Native Claims Settlement Act 43 U. S. C. Sec. 1601 et seq. and federal contractual requirements, Kikiktagruk Inupiat Corporation, may legally grant certain preference in employment opportunities to KIC Shareholders and their Descendants. EOE/AA/M/F/D/V. Please view Equal Employment Opportunity Posters provided by OFCCP here. Successful candidate must pass, comply and adhere to KIC's Drug and Alcohol policy/testing requirements and pass a thorough background check including fingerprinting.
human and animal health. We are a fast growing company and seek professional individuals to join our diverse and talented team of employees. We currently have a position for a Research Associate located at Walter Reed Army Institute of Research in Silver Spring, MD.
This position will be supporting Shigella vaccine development. KEY RESPONSIBILITIES Conducts bench research on Shigella (or other enteric pathogens) to include large scale production of purified proteins and LPS, immunogenicity, biochemistry and mechanisms of action of Shigella subunit vaccines. Assist in the evaluation of Shigella vaccines in clinical and pre-clinical studies to include immunizing small animals, collecting
blood, lymph nodes mucosal washes, and determining the immune response elicited after vaccination using cellular proliferation, antibody secreting cell (ASC), ELISA, and immunobead multiplexing assays.
Establishes and/or develops laboratory procedures and analyzes and/or evaluates research data; participates in a cooperative effort to accomplish goals of the laboratory; maintains proficiency and expertise in the field of research. Utilizes professional knowledge of: theories, principles, methods, and techniques of immunology, cell biology, and microbial pathogenesis, such as ELISA, ASC assays, cellular proliferation assays, western blotting, cell culture, small animal handling (such as
mice or guinea pigs), and aseptic technique. (NOTE: Work involving animals requires medical evaluation by a physician including animal allergy and immunization review.
) Duties shall be performed with daily interaction and technical oversight provided by the Principle Investigator. POSITION REQUIREMENTS Requires a Bachelor's degree in a scientific discipline. Must be able to pass background checks. Must be a U. S. Citizen or Green Card Holder with the right to work for any employer in the U. S. COMPENSATION/BENEFITS TMG offers comp. pay and benefits pkg. including health insurance; paid holidays, PTO; EAP; Education Assistance, 401(k) and College Savings Plan.
The Mc Connell Group is an equal opportunity employer EOE M/F/Disabled/Vet Job Posted by Applicant Pro
Research & Development (R&D) jobs are positions focused on creating new products, enhancing existing ones, or discovering new knowledge to advance technology. Individuals in these roles typically work for companies aiming to innovate and maintain competitiveness. Key characteristics of R&D jobs include problem-solving, creativity, a strong technical background, and the ability to work collaboratively. R&D professionals often engage in experimental testing, data analysis, and continuous learning to achieve breakthroughs in sciences, engineering, or other fields. The nature of these jobs is inherently dynamic, requiring adaptability and a forward-thinking mindset.
