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Senior Research Associate Drug Product Jobs

Associate Director Of Drug Product Cmc
By EPM Scientific At Greater Boston, United States
• Interpret raw data, organize results, generate/review reports, and communicate findings to project teams and management
• Extensive experience from Discovery, Pre-formulation, Formulation to Commercialization
• Experienced in formulation design, scale-up, tech transfers, & Quality by Design (QbD) studies.
• Past experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs) – highly coveted
• Experience authoring CMC sections for IND, BLA & MAA is highly sought after
Associate Director/Director - Formulations(Drug Product)
Senior Research Associate Jobs
By Lumanity At United States
1-3 years previous work-related experience with similar responsibilities
Excellent English oral and written communication skills
Strong interest in research and experience conducting academic-type research
Knowledge of the drug development process
Qualitative research data collection and analysis experience
Remote or hybrid working (remote plus working out of one of our local offices in London or Sheffield)
Senior Research Associate Jobs
By Lawrence Berkeley National Laboratory At , San Francisco Bay Area $62,316 - $79,380 a year
Demonstrated knowledge of Molecular Biology techniques including nucleic acid extractions and PCR.
Strong analytical skills including the ability to problem solve and troubleshoot experimental processes and provide analysis.
Strong oral and written communication skills including the ability to organize and share analysis reports.
Demonstrated interpersonal skills including the ability to work autonomously and as part of a diverse collaborative team.
Perform cell culture and cell line maintenance.
Perform complex experimental procedures to support DNA/RNA isolation and QC.
Associate Scientist Ii, Biologics Drug Product Development
By ABBVIE At , Irvine
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
CMC development experience in protein formulation, drug delivery, or analytical functions is preferred
Prior experience with drug product manufacture processes and lyophilization is a plus
Execute formulation composition and drug product process development studies for sterile liquids, lyophilized, and pre-filled dosage forms
Manufacture drug product formulation batches for evaluating formulation stability and/or to support animal studies
Conduct clinical in-use studies to guide dose solution administration
Research Associate, Drug Product Development
By Moderna At , Norwood, Ma
Vacation, sick time and holidays
Volunteer time to participate within your community
Paid sabbatical after 5 years; every 3 years thereafter
Here’s What You’ll Bring to the Table:
Generous paid time off, including:
Senior Product Supply Associate
By Nebraska Medicine At Omaha Metropolitan Area, United States
High school education or equivalent required.
Excellent communication skills, both written and verbal required.
Rudimentary knowledge of basic statistics and data analysis required.
Experience working with, operating, and repairing electronic medical equipment preferred.
Competitive Benefits including retirement match contribution, PTO accrual, tuition reimbursement
Work Schedule: Sunday, Tuesday-Friday with Saturday and Mondays off, 3:00pm - 11:30pm
(Senior) Research Associate Jobs
By Aethon Therapeutics At New York, NY, United States
Knowledge and experience with standard molecular and biochemical laboratory techniques, especially multi-color flow cytometry, Incucyte analysis, and ELISAs.
1-3 years of industry experience in a biotechnology/pharmaceutical company or full-time academic lab experience.
Expertise with standard mammalian cell culture techniques (thawing, culturing, freezing cell lines). Experience with transfection and/or viral transduction is preferred.
Strong verbal and written communication skills to effectively share scientific findings.
Experience or familiarity with immune cell assays, T cell immunology, and/or cancer biology is a plus.
Self-motivation and adaptability to evolving project priorities and responsibilities.
Scientist, Drug Product Development
By Moderna At Norwood, MA, United States
Participate in Drug Product teams responsible for Drug Product formulation and process development for pipeline and lifecycle management projects
Experience in clinical or commercial Drug Product (or related) GMP technology transfer and validation would be a plus.
Experience working in matrix project teams with members from peer groups, CMC teams, R&D, CMOs and CROs.
Knowledge of GMP and GLP compliance
Family care benefits, including subsidized back-up care options and on-demand tutoring
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
Fellow, Drug Product Development
By Moderna At Norwood, MA, United States
Prior management and mentorship experience; passion for people management and development
Minimum of 10 years (PhD), 14 years (MS), 16 years (BS) industry experience in biopharmaceutical development
Experience in managing development teams and serving on or leading such teams comprising membership from various functional areas
Experience in parenteral Drug Product development and commercialization, including working closely with external CDMOs.
Family care benefits, including subsidized back-up care options and on-demand tutoring
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
Research Associate, Product Transfer
By Quanterix At Billerica, MA, United States
Experience recommending how to correct component or assay issues, primarily through formulation optimization and lab techniques.
Support Manufacturing, Quality Control and Assay Development by shadowing the process and providing beneficial feedback and knowledge on the process.
Experience with development and/or validation of assay products is a plus.
Knowledge of chemistry and raw materials a plus.
Must be detail oriented with excellent organizational, record keeping, and communication skills.
BS in Chemistry, Biochemistry, Engineering, or Life Science (with 2+ years relevant experience).
Senior Expert Science & Technology (Drug Product Lead)
By Novartis At Durham, NC, United States
Communicate effectively across organizational interfaces i.e. project-management, line functions, senior management, etc.
Proactively identify scientific, technological and strategic risks, propose creative solutions and communicate key issues to the appropriate management level
Strong working knowledge of regulatory CMC expectations with significant experience with IND/BLA submissions
Previous experience in drug product process development; prior experience in adeno-associated virus and/or lentivirus gene therapy process development preferred
Proven leader that can effectively operate in a cross-functional, matrix environment and successfully manage multiple programs / priorities simultaneously
A collaborative attitude, excellent communication skills and problem solving mentality are essential for success
Senior Research Associate Jobs
By Kelly At Greater Eugene-Springfield Area, United States
Hands-on experience with in vitro cell-based assays and ELISA assays is needed.
Screening assays for inhibition of cell proliferation and other general bioassays, including ELISA assays and PCR-based assays.
Preparation of necessary buffers and solutions will be needed if not purchased.
Keeping accurate records of experimental data and writing reports in a timely manner.
Research Associate, Drug Product Development
By Moderna At Norwood, MA, United States
Relevant Experience: 0 – 2 years post Master’s Degree or 0 – 4 years post Bachelor’s Degree.
Exceptional laboratory skills with ability to work efficiently and productively in a highly dynamic environment
Knowledge of statistical design of experiments (DoE) and analysis
Knowledge of nucleic acid chemistry and biology is a plus
Preferred: Experience in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry
Preferred: Experience with nanoparticle formulation technology
Research Senior Associate Jobs
By Citi At New York, NY, United States

EEO is the Law Supplement

Senior Research Associate, Dmpk
By Biomea Fusion At San Carlos, CA, United States
BS/MS degree in chemistry, pharmaceutical science, or related scientific discipline with 3+ years of relevant experience
Hands-on experience in method development and quantitative analysis of small molecule using LC-MS/MS instruments is highly desirable
Experience with in vitro ADME assays
Working knowledge of Phoenix WinNonLin software for PK analysis is a plus
Excellent communication and writing skills
Conduct LC-MS/MS method development to support drug/metabolites and biomarker analysis
Senior Research Associate Jobs
By Bruker At San Jose, CA, United States
Highly motivated with excellent attention to detail. Good communication (oral and written) and collaboration skills.
Experience in cell culture and tissue preparation techniques.
Experience in troubleshooting and optimization of molecular biology assays including reagent formulation and workflow optimization.
Experience in product development including product release.
Advanced fluorescence imaging techniques. Experience in microscopy image analysis.
Additional Desirable Skills To Have
Senior Research Associate (Sra-Rr)
By BioSpace At Brisbane, CA, United States
Education, Experience And Skills Requirements
Any suitable combination of education, training, or experience is acceptable.
Evaluate new technologies and methodologies to support and advance analytical capabilities on the therapeutic products.
Handle and troubleshoot instrument issues such as on DNA sequencers and qPCR instruments.
Represent as subject matter expert on analytical molecular assays to support Chemistry, Manufacturing and Controls (CMC) team on new pharmaceutical products.
Supervise 2 Research Associate Contractors.
Senior Drug Safety Associate
By ONO PHARMA USA At Cambridge, MA, United States
Assists in the creation of the project specific documents such as safety management plans, narrative templates etc.
Escalates product/vendor related issues to the senior management
3 - 5 years of drug safety experience in a biotechnology, and/or pharmaceutical company.
Working knowledge of ICH/GCP guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries and GVP scope (Good Pharmacovigilance Practice.
Excellent written and verbal communication skills and must be detail oriented
Must have excellent communication and presentation skills (written and verbal).
Senior Research Associate Jobs
By Joulé At Bridgewater, NJ, United States
Experience working with cellular imaging-based instrument, fluorescence microscope, or flow cytometer is a plus
Experience working with immune cells, hematopoietic stem cells, and cancer cells is a plus
Experience working with enzymatic assays is a plus
Experience with statistical analysis programs is a plus
Perform in vitro assays including enzymatic assays, ELISA, and Luminex multiplex immunoassays
Perform molecular biology techniques such as Western Blot, PCR, and qPCR
Principal Research Associate, Drug Product Development
By Moderna At Norwood, MA, United States
Participate in Drug Product teams responsible for Drug Product formulation and process development for pipeline and lifecycle management projects
Exceptional laboratory skills and demonstrated knowledge in fill/finish unit operation characterization and scale up
Experience in clinical or commercial Drug Product (or related) GMP technology transfer and validation would be a plus.
Knowledge of GMP and GLP compliance
Family care benefits, including subsidized back-up care options and on-demand tutoring
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

Are you looking for a challenging and rewarding Senior Research Associate Drug Product position? We are looking for a highly motivated individual to join our team and help us develop innovative drug products. You will be responsible for conducting research and development activities, designing and executing experiments, and providing technical support to the team. If you have a passion for drug product development and a desire to make a difference, this is the perfect opportunity for you!

Overview A Senior Research Associate Drug Product is a professional who is responsible for researching and developing new drug products. They work closely with scientists, engineers, and other professionals to ensure that the drug products meet the highest standards of safety and efficacy. They are also responsible for ensuring that the drug products are manufactured in accordance with all applicable regulations. Detailed Job Description A Senior Research Associate Drug Product is responsible for researching and developing new drug products. This includes conducting laboratory experiments, analyzing data, and developing new drug products. They must also ensure that the drug products meet the highest standards of safety and efficacy. They must also ensure that the drug products are manufactured in accordance with all applicable regulations. The Senior Research Associate Drug Product must also be able to communicate effectively with other professionals, such as scientists, engineers, and regulatory personnel. They must also be able to work independently and as part of a team. Skills Required
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Knowledge of drug development processes and regulations
• Knowledge of laboratory techniques and equipment
• Ability to interpret and analyze data
• Ability to work under pressure and meet deadlines
Qualifications
• Bachelor’s degree in a relevant field, such as chemistry, biology, or pharmacology
• Master’s degree or higher in a relevant field is preferred
• At least 5 years of experience in drug product research and development
• Knowledge of Good Manufacturing Practices (GMPs)
Knowledge
• Knowledge of drug development processes and regulations
• Knowledge of laboratory techniques and equipment
• Knowledge of Good Manufacturing Practices (GMPs)
Experience
• At least 5 years of experience in drug product research and development
• Experience in working with scientists, engineers, and regulatory personnel
Responsibilities
• Research and develop new drug products
• Ensure that the drug products meet the highest standards of safety and efficacy
• Ensure that the drug products are manufactured in accordance with all applicable regulations
• Communicate effectively with other professionals, such as scientists, engineers, and regulatory personnel
• Work independently and as part of a team
• Interpret and analyze data
• Work under pressure and meet deadlines