Associate Scientist jobs at AstraZeneca - 841 jobs
Sr. Scientist - Beverages
Kerry 4.7
Clark, NJ jobs
Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment.
About the role
We are seeking a highly skilled and innovative RD&A Scientist to join our Beverage team. This role is responsible for developing and optimizing beverage formulations across various formats including sparkling, still, juice, and functional beverages. The ideal candidate will bring deep technical expertise, strong sensory capabilities, and a collaborative mindset to drive product innovation and meet customer expectations.
Key responsibilities
Develop and prepare beverage formulations, syrups, and concentrates at lab and pilot plant scale.
Test and refine formulations to meet specific taste profiles and regulatory standards.
Customize beverage ingredients independently or within cross-functional teams.
Calculate calories and understand the role of sweeteners and nutrients in formulations.
Facilitate sample shipments for internal and external stakeholders.
Support beverage and taste development under GMP and safety standards.
Manage multiple tasks and deadlines with speed and accuracy.
Master formulation techniques for RTD (Ready-to-Drink) and RTM (Ready-to-Make) formats.
Apply exceptional sensory skills to define and discriminate flavor profiles under tight timelines.
Demonstrate a deep understanding of beverage processing techniques and nutritional value calculations.
Communicate formulation concepts effectively in commercial settings with customers.
Apply mathematical skills to work with dilutions, percentages, and ppm calculations.
Exhibit self-motivation and resourcefulness in solving complex formulation challenges.
Qualifications and skills
Bachelor's Degree in Food Science, Biology, Chemistry, or a related Applied Science.
Minimum of 5 years of experience in beverage development and formulation.
Strong scientific and analytical aptitude.
Proficiency in Microsoft Office; experience with SAP is a plus.
Excellent problem-solving skills and ability to work independently and collaboratively.
The typical hiring range for this role is $75,602 to $123,432 annually and is based on several factors including but not limited to education, work experience, certifications, location, etc. In addition to your pay, Kerry offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and retirement contribution (all benefits and incentives are subject to eligibility requirements).
Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov).
Beware of scams online or from individuals claiming to represent us. A Kerry employee will not solicit candidates through a non-Kerry email address or phone number. In addition, Kerry does not currently utilise video chat rooms (e.g., Google Hangouts) to conduct interviews. Refuse any request that asks you to provide payment to participate in the hiring process (e.g., purchasing a “starter kit,” investing in training, or something similar). Kerry will not ask you to pay any money at any point in the hiring process with the exception of reimbursable travel expenses. In addition, any payments made by Kerry will be from official firm accounts bearing the Kerry name.
$75.6k-123.4k yearly 2d ago
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Metallurgical R&D Scientist
HTI 4.3
Augusta, GA jobs
HTI is seeking a Metallurgical R&D Scientist for a brand-new facility in Augusta, GA. This is a great opportunity to work with a state-of-the-art facility and be an important contributor to the growing North American metals supply chain.
What They Offer
Full Medical, Dental, and Vision Benefits on Day 1
401(k) Match
EAP, LTD, STD, and Life Insurance
Competitive Vacation Package
12 Paid Holidays
Relocation Assistance Available
What You Need
Bachelor's Degree in Chemical Engineering, Materials Science, Metallurgy, or a related field
Minimum of 2 years of experience, ideally in R&D, materials analysis, or process engineering
Recent graduates with relevant project or lab experience may be considered
Strong understanding of non-ferrous metallurgy and metal extraction principles, especially copper metallurgy.
Knowledge of pyrometallurgical, hydrometallurgical, and/or electrometallurgical processes
Experience with:
Material characterization and analysis
Process troubleshooting and optimization
Failure analysis and root cause investigation
Familiarity with process simulation or thermodynamic modeling tools (FactSage, Thermo-Calc, HSC, etc.) is preferred but not required
Experience preparing or interpreting process flow diagrams, phase diagrams, and thermodynamic calculations
**Candidates must be eligible to work in the U.S. without sponsorship now AND in the FUTURE**
What Your Role Will Look Like
As the Metallurgical Research & Development Scientist, you will be integral to the development and enhancement of metallurgical processes, particularly in non-ferrous extractive metallurgy with a focus on copper. Collaborating with various departments, you will lead process improvement initiatives through simulation and modeling, contribute to R&D projects, and support the broader organization in achieving its production and efficiency goals.
Key Responsibilities
Collaborate closely with cross-functional teams, including Production, Supply Chain, and Maintenance, to develop and optimize metallurgical processes.
Design and improve processes through simulation, focusing on enhancing production efficiency and effectiveness.
Conduct research and development projects, such as developing new copper alloys and analyzing the impact of using different types of electronic waste.
Utilize process simulation software to model and simulate metallurgical processes, implementing improvements to existing operations.
Prepare detailed process flow diagrams and perform calculations related to mass balance, heat balance, and phase diagrams.
Support other departments by providing expertise on chemical and material compositions and addressing process-related questions.
Ensure compliance with environmental, health, and safety standards, contributing to the development of operating instructions and risk assessments.
Participate in the ongoing development of R&D labs on-site, with a focus on future process improvements and innovations.
$52k-74k yearly est. 5d ago
Scientist - Downstream Process Development
Kelly 4.1
Gaithersburg, MD jobs
Kelly Government Solutions is seeking a Scientist - Downstream Process Development to work on-site with the Vaccine Production Program at the National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH) in Gaithersburg, MD.
KEY TASKS/SERVICES
(1) Support the Purification group of the Vaccine Production Program (VPP) Labs of the Vaccine Research Center (VRC).
(2) 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 vaccine candidates.
(3) Serve as a functional lead in chromatography process development unit operations.
(4) Provide critical process step assessment and experimental design to define optimal process parameters for chromatography unit operations.
(5) Train team members in large-scale unit operation such as AxiChrom column packing and Pilot-scale chromatography execution.
(6) Work independently and collaboratively within the purification group to design, develop and optimize chromatography and filtration step unit operations to support process development of clinical trial vaccine candidates and mAb products.
(7) Purify research-phase recombinant proteins, virus vaccines and/or virus-like particles in support of other groups at the VRC.
(8) Work to prepare necessary materials (buffers, packed columns, etc.) in support of downstream process activities.
(9) Perform protein/small molecule conjugation experiments to support method development or conjugate-based vaccine candidates.
(10) Support technology transfer of processes to VRC Pilot Plant for manufacture of clinical products including authoring process descriptions, reports, and on-floor support.
(11) Author training documents, process documents and summaries, instrument SOPs, technical reports, protocols, and other supporting documentation.
KEY REQUIREMENTS
(1) Ph.D. in Bioengineering, Chemical Engineering, Biochemistry, or related scientific discipline
(2) Extensive experience in recombinant protein purification development for GMP clinical-phase products
(3) Familiarity with monoclonal antibody and multi-specific antibodies, recombinant protein vaccine and nanoparticles; mRNA and mRNA/LNP vaccines.
$68k-93k yearly est. 5d ago
R&D Scientist
EPM Scientific 3.9
Chicago, IL jobs
Are you passionate about science and organization? We're looking for a hands-on scientist who can also drive project coordination across R&D and analytical initiatives. This role blends technical expertise with leadership in planning and communication.
What You'll Do
Track and manage R&D and analytical projects, ensuring timelines and priorities are met.
Maintain project dashboards and prepare concise progress updates for leadership.
Support formulation experiments, sample prep, and analytical testing (HPLC, dissolution, stability).
Collaborate with QA, Regulatory, and Operations to align deliverables.
Recommend process improvements and help implement standardized tools.
What We're Looking For
Education: Bachelor's or Master's in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
Experience: 3-6 years in pharmaceutical R&D, analytical chemistry, or formulation science.
Familiarity with HPLC and method development.
Strong organizational and communication skills.
Comfortable balancing lab work with coordination responsibilities.
Why Join Us
Competitive salary + comprehensive benefits.
Health, dental, vision coverage.
Retirement plan with company match.
Paid time off and holidays.
Collaborative, science-driven environment.
$70k-96k yearly est. 5d ago
Quality Control Chemist (Pharmaceutical Manufacturing)
HTI 4.3
Greenville, SC jobs
Human Technologies, Inc. has multiple openings for Quality Control Chemists with a large pharmaceutical manufacturing company located in Greenville, SC. These are direct-hire, full-time, onsite positions. Our client company offers a competitive benefits package and strong opportunities for growth and advancement.
Salary range: $55,000 - $65,000/year, depending on experience
Shifts available:
First shift: Mon-Fri 7am-4:30pm
Second shift: Mon-Fri 4pm-2:30am
REQUIREMENTS:
Must currently reside in the Greenville, SC area
Must have Bachelor's degree in Chemistry or Biology
Must have 1+ year of recent chemistry lab experience, including HPLC experience (college lab courses and/or work experience)
Training or experience in chromatographic software, instrument troubleshooting, and titrations/wet chemistry experience are preferred.
Experience in an FDA-regulated manufacturing industry is a plus.
Strong written and verbal communication skills.
Must be authorized to work in the United States without visa sponsorship (now and in the future).
JOB DUTIES:
Analyze raw materials, stability samples, and finished products to ensure they meet all quality and compliance requirements.
Accurately follow all established SOP's/processes and safety procedures.
HPLC and GC methodology and analyses, including preparations (extractions, dissolution, ISE separation, etc.)
Titrations, USP/NF limit tests, identifications, TLC, etc.
Accurately document all test/analysis data in a timely manner; perform reviews of laboratory documentation.
Testing and release of manufactured bulk products for packaging.
Assist with inventory of required lab materials.
Maintain a clean and safe workspace.
Equal Opportunity Employer
$55k-65k yearly 5d ago
Drug Product Analytical Development Scientist
Eurofins Us Network 4.4
Groton, CT jobs
Groton, CT, USA Full-time ** Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
**Job Description**
+ Design and guide analytical strategies to support manufacturing process development.
+ Lead the planning, development, execution, and data interpretation performed by other scientists in a collaborative, matrixed environment.
+ Oversee and review the development, validation, and transfer of analytical methods to ensure robust and reliable data generation.
+ Manage stability studies to assess degradation pathways and establish shelf-life parameters.
+ Develop impurity control strategies to ensure product quality and regulatory compliance.
+ Experience with a wide range of analytical testing including dissolution, HPLC/UPLC, SFC, disintegration, compendial testing (e.g., excipients / packaging release testing), generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV) and compound specific methods
+ Collaborate with cross-functional teams to identify and apply the most effective analytical techniques, including the use of computational modeling, predictive tools, and data visualization platforms.
+ Evaluate scientific data to draw clear conclusions, guide future work, and communicate findings through presentations, technical reports, and other media.
+ Contribute to regulatory submissions by authoring relevant sections of the quality modules, ensuring alignment with global standards and expectations.
+ Maintain compliance with GLP/GMP standard and safety protocols
**Qualifications**
+ PhD in Chemistry, or related field, with 3+ years of pharmaceutical R&D experience or a B.S./M.S. with 15+ years
+ Strong oral and written communication skills.
+ Experience in a regulated laboratory environment (GLP/GMP).
+ Proven ability to lead scientific projects and mentor team members.
+ Proficiency in analytical instrumentation and techniques.
+ Familiarity with regulatory documentation and submission processes.
**Additional Information**
+ Position is full-time, Monday-Friday, 8:00 am - 5:00 pm.
+ Candidates currently living within a commutable distance of Groton, CT are encouraged to apply
+ Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
+ Life and disability insurance
+ 401(k) with company match
+ Paid vacation and holidays
+ **\#LI-EB1**
+ Authorization to work in the United States indefinitely without restriction or sponsorship
**Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.**
At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Your Role: Technical Services Manufacturing Scientist - Downstream
The Technical Services & Manufacturing Science (TS/MS) Scientist is responsible for providing Primary and/or Secondary loop technical support for commercial downstream operations at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The position is a subject matter expert with respect to mAb products and processes and is engaged in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting and continuous improvement activities. The TSMS scientist plays a key role in day-to-day operations and delivery of technical projects.
Your Responsibilities:
Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products. This includes troubleshooting, participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events.
Act as the Process Teams product and process subject matter expert for purification processes which may include chromatography, tangential flow filtration, and centrifugation.
Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements.
Develop / execute projects to address process performance issues and deliver improvement opportunities.
Author and provide critical review of technical documents including, but not limited to; batch records, SOPs, PFDs, process recipes, risk assessments, investigations, technical studies, protocols, and reports.
What You Need to Succeed (minimum qualifications):
Education: Bachelor's degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
Experience: Experience in the Biotech / Pharmaceutical industry.
Detailed understanding of biopharmaceutical production processes and technologies. Working knowledge of cGMP standards and experience working in a regulated environment. Proven analytical thinking and problem-solving skills.
What will give you a competitive edge (preferred qualifications):
MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline.
Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes.
Experience in tech transfer, scale up, and validation of biopharmaceutical processes.
Experience with SAP, JMP, Veeva Vault, RCI, FMEA and QRM tools.
Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.
Additional Information:
Location: Elwood, Kansas.
Day shift position. Weekend work on a rotation to provide process support to ongoing operations.
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco, we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages for eligible roles
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Up to 6% 401K matching
#LI_MNLC
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
$59k-78k yearly est. Auto-Apply 52d ago
Technical Services Manufacturing Scientist (TSMS) Associate- Pilot Scale
Elanco 4.9
Elwood, KS jobs
At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose™ - to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Your Role: Technical Services & Manufacturing Science (TSMS) Associate -Pilot Scale
The Technical Services & Manufacturing Science (TSMS) Associate is responsible for providing operational and technical support for commercial and pilot laboratory operations at the Elwood, Kansas, monoclonal antibody (mAb) manufacturing facility. The position is a subject matter expert with respect to mAb products and processes and is engaged in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting, and continuous improvement activities.
Your Responsibilities:
Support the execution and troubleshooting of upstream and/or downstream manufacturing processes for biologics (e.g., mammalian cell culture, purification).
Collaborate with Manufacturing, Development, and Quality teams in the execution of technical / development studies, investigations, validation activities, and technical transfer programs, and collaborate with team members to identify potential risks, sources of variability, improvement, and value engineering opportunities to maximize project return and likelihood of technical success.
Provide on-floor support during manufacturing campaigns, including troubleshooting and deviation investigations.
Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements.
Author and provide critical review of technical documents, including, but not limited to: batch records, SOPs, PFDs, risk assessments, investigations, technical studies, commissioning and qualification protocols, and reports.
Assist in implementing changes through the change control system (e.g., BOM updates, process changes).
What You Need to Succeed (minimum qualifications):
Education: Bachelor's degree or equivalent in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
Experience: 0 - 2 years' experience in the Biotech / Pharmaceutical industry.
Familiarity with tools such as JMP or Excel for data analysis is a plus.
Ability to work in a team environment and support manufacturing activities on the production floor, including occasional off-shift or weekend support if required.
Detailed understanding of biopharmaceutical production processes and technologies with working knowledge of cGMP standards and experience working in a regulated environment.
What will give you a competitive edge (preferred qualifications):
MSc in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
3+ years' experience in the Biotech / Pharmaceutical industry.
Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes.
Experience in tech transfer, scale-up, and validation of biopharmaceutical processes.
Experience in capital project design, development, validation, and execution.
Experience with electronic quality systems (e.g., Veeva QMS, TrackWise) and MES platforms.
Additional Information:
Location: Elwood, Kansas
Day shift position. Weekend and evening work is not usual, although it may be required to provide process support to ongoing operations.
Minimal travel requirements < 10%.
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
$59k-78k yearly est. Auto-Apply 60d+ ago
Associate Scientist, Bioanalytical Services
Frontage Laboratories 3.9
Exton, PA jobs
Title: AssociateScientist, Bioanalytical Services
Responsibilities:
AssociateScientist / Bioanalytical Services Essential Functions Provide support for running sensitive, reliable and efficient LC-MS/MS bioanalytical assays for TK/PK assessment
Coordinate study activities with Responsible Scientist to ensure efficiency and quality
Aid in the preparation of study summaries and/or reports
Maintain the proper level of regulatory compliance for each study, helping to address QA audit findings
Ensure that GLP regulations and SOPs are followed in all bioanalytical service activities
Follow safety precautions
Job Requirements :
Experience using Sciex Analyst software, and Watson LIMS, a plus
Ability to successfully work in a team environment. Excellent oral and written communication skills
Bachelor's degree or Master's degree in a related scientific discipline
Salary and Benefits :
Frontage Laboratories offers a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, health insurance, short and long-term disability insurance, life insurance etc.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
$55k-78k yearly est. Auto-Apply 29d ago
Associate Scientist
Frontage Lab 3.9
Exton, PA jobs
Job Title: AssociateScientist, Drug Metabolism and Pharmacokinetics (DMPK) Reports To: Vivarium Manager / Study Director Company Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position Summary:
A dedicated and detail-oriented Vivarium AssociateScientist to support studies. This role involves the routine care and handling of laboratory animals, preparation for in vivo studies, and collaboration with scientific staff to ensure timely and high-quality data and sample collection in compliance with study protocols and animal welfare regulations.
Key Responsibilities:
* Perform daily husbandry tasks including feeding, watering, cage changing, and health monitoring.
* Assist with in vivo dosing procedures (e.g., oral, intravenous, subcutaneous) under supervision or upon training certification.
* Conduct biological sample collection (e.g., blood, urine, feces, tissues) following approved protocols and SOPs.
* Maintain accurate records of animal health, treatments, and study-specific procedures.
* Prepare and label dosing and sampling materials and ensure proper sample storage and tracking.
* Perform minor vascular and major surgical procedures
* Monitor animals for clinical signs and report any abnormalities to the study team or veterinary staff.
* Ensure vivarium cleanliness and compliance with IACUC and AAALAC standards.
* Collaborate with DMPK scientists and project teams to coordinate study timelines and logistics.
* Assist with inventory and ordering of animal care and dosing supplies.
Qualifications:
* Associate's or Bachelor's degree in Animal Science, Biology, or a related field preferred.
* ALAT certification or willingness to obtain preferred.
* Experience working with laboratory animals in a research or CRO environment (rodents required).
* Familiarity with in vivo DMPK study procedures is a plus.
* Ability to follow SOPs, protocols, and regulatory guidelines (GLP, IACUC).
* Strong organizational skills and attention to detail.
* Ability to work occasional weekends and holidays as study needs require.
Physical Requirements:
* Ability to lift up to 50 lbs and perform physical tasks such as bending, stooping, and prolonged standing.
* Comfortable working in a controlled environment with laboratory animals.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability
$55k-78k yearly est. 43d ago
Associate Scientist
Frontage Lab 3.9
Exton, PA jobs
AssociateScientist (Pharmacokinetics) - Biologics Job Title: AssociateScientist (Pharmacokinetics) - Biologics Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Job Summary: We are seeking a highly motivated and detail-oriented AssociateScientist to join our Pharmacokinetics (PK) group. The successful candidate will support bioanalytical method development, validation, and sample analysis using ligand binding assays (LBA) to assess pharmacokinetics for preclinical and clinical studies. This role requires expertise in bioanalytical techniques, data analysis, and regulatory compliance.
Key Responsibilities:
* Develop, optimize, and validate ligand binding assays (e.g., ELISA, MSD, Gyrolab) for quantifying therapeutic molecules in PK studies.
* Perform routine bioanalysis of preclinical and clinical samples under GLP and non-GLP conditions.
* Analyze and interpret experimental data, ensuring accuracy, reproducibility, and regulatory compliance.
* Troubleshoot and resolve technical issues related to assay performance and instrumentation.
* Maintain detailed and organized records of experimental procedures and results in laboratory notebooks and electronic systems.
* Contribute to the preparation of bioanalytical reports, method validation reports, and regulatory submissions.
* Collaborate with pharmacokinetics, toxicology, clinical, and regulatory teams to support drug development programs.
* Ensure compliance with regulatory guidelines (GLP, FDA, EMA) and company policies for bioanalytical studies.
Qualifications:
* Bachelor's or master's degree in Biochemistry, Molecular Biology, Immunology, Pharmaceutical Sciences, or a related field.
* Entry-level candidates, including recent graduates, are encouraged to apply. Hands-on experience in ligand binding assay development, validation, and sample analysis through coursework, internships, or research projects is a plus.
* Familiarity with bioanalytical techniques such as ELISA, MSD, and Gyrolab.
* Knowledge of pharmacokinetics, immunogenicity assessment, and bioanalytical regulatory requirements.
* Experience in a GLP-compliant environment is a plus.
* Strong analytical and problem-solving skills with the ability to troubleshoot assay performance issues.
* Excellent organizational skills and attention to detail.
* Effective communication and teamwork skills to collaborate with multidisciplinary teams.
Preferred Qualifications:
* Experience with automated liquid handling systems for bioanalysis is a plus; training opportunities will be provided for candidates eager to learn automation.
* Proficient in coding language for data analysis and automation (e.g., Python, Kotlin).
* Familiarity with software for data analysis (e.g., SoftMax Pro, Watson LIMS, GraphPad Prism).
* Understanding of regulatory expectations for bioanalytical method validation (FDA, EMA, ICH guidelines).
* Bilingual (Mandarin/English) preferred.
Why Join Us?
* Be part of a collaborative and innovative bioanalytical team supporting groundbreaking drug development.
* Gain exposure to cutting-edge bioanalytical techniques and regulatory-driven workflows.
* Opportunity for career growth within a dynamic and fast-paced research environment.
If you are passionate about bioanalysis and eager to contribute to the development of novel therapeutics, we encourage you to apply for this exciting opportunity.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
$55k-78k yearly est. 24d ago
Scientist/Associate Scientist- Biomarker
Frontage Lab 3.9
Exton, PA jobs
Title: Scientist/AssociateScientist, Biomarker Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Biomarker Services:
Our biomarker scientists have developed and validated a large number of biomarker assays for pharmaceutical and biotech companies. We are proud to become a benchmark in the field and have a significant impact for our clients using our expertise and state-of-the-art technology to advance/monitor drug development. We have also published novel biomarker assays developed in-house to share our expertise with the industry. With the addition of new technologies such as ELLA and Luminex for biomarker analysis, we believe we will continue as a top-notch provider of biomarker assays in the years to come.
Position Summary:
Scientist/AssociateScientist aids in the development of bioanalytical methods.
Responsibilities:
* Conduct method validation for bioanalytical methods and conduct sample testings.
* Complies with all relevant GLP and/or cGMP regulatory requirements while carrying out
assigned tasks.
* Utilizing various types of instruments including LC-MS, SIMOA, MSD, SP-X, ELLA, etc.
* Assist principal investigator and responsible scientist to perform the projects
Requirements:
* Scientist B.S. level with 1+ year experience or M.S. level or above
* AssociateScientist- B.S. level without experience
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
$55k-78k yearly est. 35d ago
Associate Scientist/Scientist-Biologics
Frontage Lab 3.9
Exton, PA jobs
AssociateScientist/Scientist - Biologics - BDDS Full Time Exton, PA Frontage Laboratories Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Biologics
Frontage's biologics teams have an average of 10-15 years in complex drug development and have worked with large molecule applications throughout its evolution in product development. We can handle projects for a range of large molecule development projects including peptides, proteins, monoclonal antibodies, bispecific antibodies, biosimilars, oligonucleotides, biomarkers , and antibody drug conjugates.
Gain access to comprehensive biologics services in support of advanced development programs with Frontage's bioanalytical laboratory. We have the capabilities to analyze virtually any peptide, protein, or antibody, and have built a reputation for solving technical challenges related to assay development and validation.
Position Summary
This is a technical bench scientific position within the Biologics Service Team. The Biologics Service Team is responsible for conducting bioanalytical methods Pharmacokinetics (PK), and Anti-drug Antibody (ADA) related to large molecule biotherapeutic drug development across all therapeutic areas, spanning nonclinical studies to post-market clinical development. The scientist will assist with the interpretation of data resulting from analyses of bioanalytical samples, and work with senior staff to assess, troubleshoot, develop, and validate new assays. They may also perform other duties, as assigned, to meet business needs.
Responsibilities
* Responsible for qualification and preparation of controls and reagents to support PK, and ADA assay methods to quantify concentrations of therapeutic proteins.
* Required to assist with assay validations, routine lab operations.
* Responsible for maintaining an electronic lab notebook, participation in GLP compliance activities and other duties as needed.
* Performs job duties with some supervision. Collaborates effectively with fellow team members following priorities, checkpoints, and timelines in support of objectives set by direct supervisors.
* Communicates with internal and external team members regarding assigned tasks through written and oral communication.
Requirements
* BS or MS in biochemistry, biomarker, molecular biology, or a related field.
* Experience in immunoassay development and validation in a GLP lab (21CFR part 11 compliant) is preferred.
* Experience with Meso Scale Discovery (MSD) immunoassays or ELISA.
* Experience in a biopharma company, Clinical Research Organization (CRO) or diagnostic lab environment is preferred.
Salary And Benefits
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
$55k-78k yearly est. 24d ago
Associate Scientist, Pharmaceutical Analysis, Small Molecule
Frontage Lab 3.9
Exton, PA jobs
AssociateScientist, Pharmaceutical Analysis-Small Molecule Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Responsibilities:
* Performs routine sample analysis and a variety of tasks to support product development, ensuring agreed timelines
* Assists method development Performs method validation under supervision
* Reports and resolves any unexpected issues under supervision
* Complies with all relevant cGMP and/or GLP regulatory requirements while carrying out assigned studies
Requirements:
* B.S. in Chemistry or related discipline
* 1-2 years of related industry experience preferred
* Hands-on experience with HPLC, UPLC, GC, LC/MS, IC and Dissolution Testing
* Excellent oral and written communications skills
* Capable of setting priorities based on a fast-paced, changing environment Good team player to work with Formulators and QA CRO experience is a plus.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
$55k-78k yearly est. 43d ago
Associate Scientist
Frontage Laboratories 3.9
Exton, PA jobs
AssociateScientist/Scientist- Cell-Based Assay Core Facility
Title: AssociateScientist/Scientist
Reports to: Associate Director, Core lab of Cell-based assay
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Cell-based Assay Core Lab
The Cell-based Assay Core Lab, based at our Exton headquarters, stands as a premier provider of diverse cell-based assays. These include potency assays, neutralizing antibodies assays, EliSpot, virus plaque assay, TCID50 Assays etc.
We are seeking a candidate with a fundamental understanding of Cell Biology, Biochemistry, and Molecular Biology. The ideal candidate should be highly organized, self-motivated, enthusiastic about learning, and capable of managing multiple projects concurrently.
Responsibilities:
Perform job duties with some supervision, with majority of interaction with direct supervisor and project team members.
Prepare cell media and reagents, culture and maintain cell lines, perform transfection and transduction.
Responsible for method development, qualification, validation and sample analysis for immunogenicity assay and cell-based assay.
Document experimental procedures and results in a timely manner
Draft, review, and finalize bioanalytical plans, protocols, and reports.
The Role may also involve communication with external clients with project-related questions.
Other responsibility as needed.
Qualifications and Preferred:
Bachelor's or master's degree in molecular biology, cell biology, biochemistry, or a related field.
Experience with aseptic techniques and cell culture (suspension and adherent) is required.
Experience with Organoids and 3D cell culture is a plus, but not required.
Experience with molecular biology techniques (qPCR/dd PCR/ Elisa/ Western Blot) is a plus, but not required.
Hands-on experience with immunofluorescence microscopy is preferred.
Ability to learn new techniques, work on multiple projects concurrently, maintain accurate records, and comply with company policies/SOPs.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
$55k-78k yearly est. Auto-Apply 60d+ ago
Associate Scientist II, Molecular & Computational Biology
Tonix Pharmaceutical 3.8
Frederick, MD jobs
About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults.
Tonix's development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA.
Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.
Please visit ******************* for specifics on the pipeline.
* All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication.
Position Overview
Tonix Pharmaceuticals is seeking a highly motivated AssociateScientist to join our multidisciplinary R&D team at the Frederick Research & Development Center. This role integrates computational protein structure analysis with hands-on molecular biology and protein biochemistry. The successful candidate will contribute to host-directed therapeutic discovery, antiviral platforms, and vaccine design by combining AI/ML-based protein modeling with molecular biology and protein science to generate, express, and analyze protein targets.
Key Responsibilities
* Perform protein structure modeling and design using platforms such as AlphaFold2/3, ESM, RFdiffusion, ProteinMPNN, and NetMHC.
* Build and refine bioinformatics workflows for large-scale sequence and structural analysis of host and viral proteins
* Perform molecular cloning, PCR, DNA and RNA isolation, bacterial transformation, and mutagenesis to generate expression constructs.
* Carry out protein expression and purification followed by protein characterization
* Collaborate with Tonix's imaging and cell biology teams to translate computational predictions into testable hypotheses in assays and animal models.
* Contribute to the development of user-friendly computational pipelines and visualization tools for internal scientists.
* Document and communicate results in reports, regulatory filings, and presentations to internal teams, collaborators, and external partners.
* Maintain awareness of emerging computational biology technologies to enhance Tonix's drug discovery capabilities.
Required Qualifications
* B.S. or M.S. in Microbiology, Biochemistry, Bioinformatics, Computational Biology, or related field.
* Hands-on experience with protein structure prediction and computational protein design tools.
* Familiarity with core molecular biology and protein biochemistry methods (PCR, cloning, bacterial expression, Western blotting).
* Strong communication skills and ability to work in cross-functional teams within Tonix's integrated discovery pipeline.
Preferred:
* Experience with cloud computing platforms (Google Cloud, AWS) for large-scale protein modeling.
* Exposure to machine learning approaches in protein design and immunology.
* Prior experience with protein engineering for therapeutic applications.
* Track record of contributions to publications, posters, or conference presentations.
* Proficiency in Python, especially ML/AI packages. Experience in Linux operating systems and shell programming is desirable.
Recruitment & Staffing Agencies
Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes.
Compensation & Benefits
Annualized base salary ranges from $60,000 to $90,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit.
Tonix provides a comprehensive compensation and benefits package which includes:
* Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
* Pet Insurance
* Retirement Savings 401k with company match and annual discretionary stock options
* Generous Paid Time Off, Sick Time, & Paid Holidays
* Career Development and Training
Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.
$60k-90k yearly 38d ago
Process Development, Associate Director - Cell Line Development (CLD), Biologics
Vertex Pharmaceuticals 4.6
Boston, MA jobs
Vertex is seeking a highly skilled technical leader to join our Process Development / Engineering team to lead and manage activities related to cell line development (CLD) for the production of monoclonal antibodies and other therapeutic biologics, with a strong focus on overseeing programs conducted at external CDMOs. This role is critical in advancing our pipeline of innovative biologics from early development through to commercial readiness. The Vertex Process Development team offers a dynamic, fast-paced, and highly collaborative environment with a tremendous impact on our programs and for our patients. Our team focuses on bringing together the best process design, scale-up and cutting-edge manufacturing technologies to enable the successful implementation of Biologics, Cell and Genetic therapeutics.
The successful candidate will bring deep technical knowledge in cell line development and act as the technical lead for CLD work. This is a highly cross-functional role that will work closely with drug substance development, analytical development, external manufacturing and supply chain management in CMC teams to drive technical and strategic decision-making.
Key Duties and Responsibilities:
Lead phase-appropriate strategies to develop, select, and characterize stable, high-producing cell lines for monoclonal antibodies, ADCs and other biologics modalities.
Evaluate, select and manage external capabilities for cell line development.
Oversee and review all aspects of the CLD process, including vector design, transfection, clone screening, characterization and cell line stability studies.
Ensure regulatory-compliant cell line development workflows, including clonality documentation and cell bank generation.
Develop and manage project timelines and budget for CLD activites.
Ensure project deliverables, quality standards, and timelines are met in alignment with internal program goals.
Collaborate with internal cross-functional teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs to ensure alignment and knowledge transfer.
Review and approve technical protocols, development reports, and data packages provided by CDMOs.
Provide scientific and strategic input into cell line platform development, technology evaluation, and implementation of innovation from external partners.
Support regulatory submissions (IND/IMPD/BLA) by contributing to or authoring relevant sections and responding to agency queries related to CLD.
Serve as a subject matter expert in regulatory agency interactions, audits, and inspections.
Expected travel: 10-20% (domestic and international)
Required Education:
PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or related discipline with commensurate years of education and experience.
Minimum of 8 years of experience in drug substance development and manufacturing. MS with 12+ years of relevant experience may be considered.
Required Experience and Skills:
Demonstrated expertise in cell line development for therapeutic proteins including antibodies, ADCs, and fusion proteins.
Strong understanding of molecular biology techniques, vector construction, clone selection strategies, and cell line characterization methods. Familiarity with industry-leading expression platforms (e.g., GS, CHOZN, CHEF1, etc.) is strongly preferred.
Knowledge of upstream process development and analytical methods related to CLD.
Hands-on experience managing external CDMOs and navigating cross-functional and cross-organizational workflows.
Experience in authoring and reviewing relevant CMC sections of regulatory filings (IND, BLA, etc.).
Proven track record of delivering on complex biologics development programs.
Excellent interpersonal, communication, and organizational skills.
Ability to work independently, manage multiple projects simultaneously, and operate in a fast-paced environment.
#LI-LE1
Pay Range:
$166,800 - $250,200
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Onsite
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
$73k-88k yearly est. Auto-Apply 52d ago
Associate Scientist - R&D
Clinical Diagnostic Solutions 4.8
Plantation, FL jobs
Clinical Diagnostic Solutions, Inc. (CDS) is a company that provides total hematology solutions for the physician office laboratory, clinic, small hospital, and veterinary office markets. At CDS, our mission is to provide the highest quality experience to our valued customers. Our employees achieve this through our cultural goals of working together through Teamwork, high Quality in the work we do, being Innovative and Courageous, always Results Oriented, and most importantly - being Customer Oriented.
Under supervision, uses fundamental concepts, practices, and procedures of particular field of specialization to perform scientific, R&D tasks of some complexity requiring application and adaptation of established techniques, procedures, and criteria. Participates in new product development, optimization, validation, and transfer into production. Prioritizes work schedules to support team objectives.
Job Responsibilities:
Participates in method development and technical innovation within the research team and supports project timelines
Performs method optimizations, validations and participates in technology transfer to production
Performs routine operation, maintenance, calibration and troubleshooting of laboratory instruments such as pH, conductivity meters, osmometers, spectrnphotometers, hematology analyzers and nucroscopes
Evaluates and selects methods, applies protocols and scientific techniques to accomplish study objectives
Drafts and updates protocols, test methods and standard operating procedures as applicable
Proactively collaborates and supports the team, communicates problems as they arise
Provides solution/s to problem/ s of limited complexity, exercises judgment within defined policies to determine appropriate action
Collects, analyzes and compiles data. Summarizes for interpretation and discussion
Drafts statistical and narrative reports as applicable
Recognizes and reports experimental variances
Is able to coordinate a small project or a small component of a larger project according to set deliverables
Maintains good laboratory records and documentation for experimental work and results Maintains workplace safety and environmental practices
Maintains clean workplace including laboratory bench and glassware
Supports the department with QC technical investigation activities as needed
Works in the spirit of continuous improvement
Engages in inter and intra-departmental activities/studies Performs other related duties as required or as directed. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.
Qualifications:
Knowledge of scientific approach and methodologies.
Ability to design small studies, gather, organize and analyze statistical data and generate reports
Excellent oral and written communication skills
Ability to investigate and analyze information and to draw conclusions
Skill in the use of personal computers and related software applications such as Word/Excel/Powerpoint/Teams
Knowledge of current technological developments/trends in area of expertise is desirable but not required
Capable of adjusting to dynamic work environment and changing priorities
Willing to take on new challenges and implement new ideas
Must be Comfortable handling blood products
Willing to embrace a learning environment, is open to suggestions, new ideas and innovation
Ability to grasp methods fast and willingness to change course as applicable
Familiar with GLP, GMP practices and capable of working in a regulated medical device company (ISO and FDA)
Must have strong analytical skills
Must be a team player and driven individual Must value innovation, accuracy and accountability
Minimum Requirements:
Bachelor's degree with 2-5 years or Associates degree with 5-8 years' experience that is directly related to the duties and responsibilities specified.
EOE
$49k-76k yearly est. 60d+ ago
Research Chemist (E&L)
Nivagen Pharmaceuticals 3.7
Sacramento, CA jobs
About the Company:
Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.
Job Location:
Nivagen Pharmaceuticals Inc., Sacramento, CA
3900 Duckhorn Dr, Sacramento, CA 95834
About the Job:
Title of the Position: Research Chemist (E&L)
We are seeking an experienced Research Chemist (E&L) with a minimum of 3-5 years of pharmaceutical industry experience.
Responsibilities:
Maintain, operate, and troubleshoot LC-MS and GC-MS, GC-FID, and ICP-MS Systems.
Perform extraction, analysis, and characterization of extractables and leachables from polymeric materials associated with container closure systems of pharmaceutical drug products as per USP, PQRI, ICH and other regulatory guidelines.
Develop and optimize sample preparation techniques for analysis on GC-MS, LC-MS, and ICP-MS systems.
Develop and validate LC-MS, GC-MS, and ICP-MS methods for finished product and raw material characterization as well as extractable/leachable testing.
Unknown impurity identifications using GC-MS, LC-MS, and LC-MS/MS or other suitable techniques.
Interpret complex spectral data and fragmentation patterns.
Routine stability testing of API, finished product samples for assay and impurities using various instrumental techniques as suited, and prepare stability data summaries.
Generate study designs, write protocols, methods, Datasheets and reports.
Provide support in the critical review of analytical data, reports and protocols.
Write Instrument-related SOPs and provide training on the instrument and related software.
Train new recruits in the lab and support the team as needed.
Participate in internal meetings and conferences.
Provide support during technical transfer between R&D and QC.
Whenever needed, attend SOP, Safety, and scientific trainings to remain current with cGMP regulations, safety standards, and development technologies.
Preparation and review of analytical methods, method validation, and related study reports for ANDA/ NDA submissions and support, document preparation for ANDA/ NDA submissions.
Any other activities as directed by the supervisor.
Qualifications:
Education/Experience:
Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field.
Knowledge, Skills, and Abilities:
Familiarity with the characterization and isolation of impurities.
Strong foundation in organic chemistry and structural elucidation, with expertise in small molecule pharmaceutical drug development and peptides, including computational techniques.
Proficiency in using standard laboratory equipment, including pipettes, graduated cylinders, and balances.
Skilled in laboratory techniques for measuring, weighing, and handling samples.
Hands-on experience with HPLC (highly preferred).
Knowledge of chemical handling procedures, including safety precautions and documentation such as Safety Data Sheets (SDS).
Competency in Microsoft Office applications.
Experience or familiarity with current Good Manufacturing Practices (cGMP) is preferred.
Requirements:
Must live or be willing to move to the Sacramento Metropolitan Region (Approximately 40 miles' radius)
Benefits:
Pay range $70,000 - $85,000 per Year
Yearly bonus eligibility
Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
Medical, dental and vision coverage
Paid time off plan
401 (k) savings plan
Additional Information:
Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment o retaliation based on any of these factors.
$70k-85k yearly Auto-Apply 17d ago
Drug Product Analytical Development Scientist
Eurofins Scientific 4.4
Groton, MA jobs
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
* Design and guide analytical strategies to support manufacturing process development.
* Lead the planning, development, execution, and data interpretation performed by other scientists in a collaborative, matrixed environment.
* Oversee and review the development, validation, and transfer of analytical methods to ensure robust and reliable data generation.
* Manage stability studies to assess degradation pathways and establish shelf-life parameters.
* Develop impurity control strategies to ensure product quality and regulatory compliance.
* Experience with a wide range of analytical testing including dissolution, HPLC/UPLC, SFC, disintegration, compendial testing (e.g., excipients / packaging release testing), generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV) and compound specific methods
* Collaborate with cross-functional teams to identify and apply the most effective analytical techniques, including the use of computational modeling, predictive tools, and data visualization platforms.
* Evaluate scientific data to draw clear conclusions, guide future work, and communicate findings through presentations, technical reports, and other media.
* Contribute to regulatory submissions by authoring relevant sections of the quality modules, ensuring alignment with global standards and expectations.
* Maintain compliance with GLP/GMP standard and safety protocols
Qualifications
* PhD in Chemistry, or related field, with 3+ years of pharmaceutical R&D experience or a B.S./M.S. with 15+ years
* Strong oral and written communication skills.
* Experience in a regulated laboratory environment (GLP/GMP).
* Proven ability to lead scientific projects and mentor team members.
* Proficiency in analytical instrumentation and techniques.
* Familiarity with regulatory documentation and submission processes.
Additional Information
* Position is full-time, Monday-Friday, 8:00 am - 5:00 pm.
* Candidates currently living within a commutable distance of Groton, CT are encouraged to apply
* Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
* Life and disability insurance
* 401(k) with company match
* Paid vacation and holidays
* #LI-EB1
* Authorization to work in the United States indefinitely without restriction or sponsorship
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.