Senior Clinical Scientist, Early Clinical Development - Hematology/Oncology & Cell Therapy
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. But working at Bristol Myers Squibb is anything but usual.$122k-147k yearly est.2d ago
Senior Scientist
Immediate need for a talented
Senior Scientist
. This is a
12+ Months
contract opportunity with long-term potential and is located in
Summit, NJ(Hybrid).
Please review the job description below and contact me ASAP if you are interested.
Job ID:23-11290
Pay Range: $45 - $49/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location)
.
Key Responsibilities:
Operate in a matrix team environment with collaboration with analytical development, global quality product leads, technical project teams, and regulatory groups etc. within Client.
Support of commercial analytical change controls
Support life cycle of regulatory filings, participates in preparation/reviewing of licensure applications, rest of world filings, follow-up measures, post-approval commitments and prior approval submissions
Gathering, interpretation and presentation of data to support decision making
Maintain effective partnerships with stakeholders from analytical development, Manufacturing Sciences and Technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success.
Share expertise with matrix teams in support of analytical topics related to FDA, MMA, ROW & Client filing review.
Support implementation of effective control strategy, analytical method and specification change control as needed throughout the Client network, third party manufacturing and outside testing labs.
Serve as a subject matter expert for project, including technical evaluations of methods and data.
Key Requirements and Technology Experience:
Comprehensive knowledge and experience of analytical methodologies used for the development and commercialization of pharmaceutical products.
Demonstrate a broad expertise and experience in analytics routinely used for in-process, release and stability testing of drug substance and drug product, product characterization and strategies to establish process and product knowledge.
Extensive knowledge of the drug development process, analytical strategy and specification setting for drug substance and drug product
Familiar with FAD, ICH guidance and major Pharmacopoeias.
Working knowledge of CMC regulations and cGMP requirements, as well as experience in supporting regulatory filings and post approval changes.
Strong communication and leadership skills in a highly interactive and fast paced environment.
Experience in working with cross-functional strategic teams and collaboration with internal and external partners.
A PhD, MS, or BS in Analytical Chemistry, Chemistry, or related disciplines with at least 1, 3, or 4 years of pharmaceutical industrial experience in relevant fields, respectively.
This is primarily a analytical subject expertise and analytical project management role for a commercial program, including office work, teleconferencing, computer work, and running meetings, as well as working with quality control analysts in a laboratory setting requiring:
Inside Work
Working Alone
Working with/around others
Our client is a leading
Pharmaceutical
organization and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
$45-49 hourly3d ago
Engineering - Assistant/Associate Scientist
On-Board Scientific is hiring an Assistant/ Associate Scientist in Summit, NJ! The Assistant/Associate Scientist contract position will be in the Downstream Process Development group in Summit, NJ, and be responsible for the development of scalable purification processes, process characterization, Tox material production, and tech transfer to GMP facilities for clinical/commercial manufacturing. On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. Today, On-Board is a thriving privately held family of companies with services including Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America. Job Location: Summit, NJ The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. www.onboardusa.com On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry.$41.9-43.2 hourly25d ago
Scientist 2 - Research and Development (contract)
Location: Raritan, NJ$79k-109k yearly est.8d ago
Y - Bioinformatics Scientist in Lawrenceville, NJ, US
Summary: We are seeking a passionate scientist to join our Disease Strategy and Late Stage Hematology team in the Translational Bioinformatics group. 50%Onsite Senior Research Scientist, Disease Strategy and Late Stage Hematology, Translational Bioinformatics$78k-112k yearly est.8d ago
Staff Scientist
Peak Environmental, A Nova Group, GBC Company$81k-122k yearly est.11d ago
Engineering - Senior Associate Scientist
The Principal/Sr. Scientist conducts product and process characterization studies; collaborates with research and development in drug product process development of sterile parenteral and biologics drug product and works with manufacturing sites to characterize, troubleshoot or optimize processes for lifecycle products. This position is accountable for the design and execution of process characterization to ensure robust parenteral manufacturing processes. This applies to both new products and key life cycle management products. Additional responsibilities may include development of new manufacturing technologies and providing specialized expertise as necessary to complement site capabilities for critical investigations or process improvements.
Key Responsibilities Include
Execution of post-market process change activities/experiments through partnership with R&D development
assets.
Characterization, optimization and troubleshooting product and manufacturing processes of parenteral dosage
forms.
Collaboration with R&D and manufacturing sites to design and execute experiments to support product
robustness, new technology implementation, and/or manufacturing investigations
Serve as technical resource to other functions, providing expertise on the product and its process.
Effectively represent biologics drug product manufacturing science and technology in various internal and
external teams and committees on development, technology transfer, manufacturing, specifications, process
validations and launch.
Provide assistance to sites globally to resolve significant quality events
Qualifications
Advance degree in the Pharmaceutical or Biotechnology industry in product and process development and
commercialization in a global environment with 6 years industry experience for Sr. Scientist or 8 years experience
for Principal Scientist. Ph.D. degree preferred.
Expertise in parenteral product development and manufacturing
Key Skills And Experience
Hands-on experience in the laboratory
Excellent Skills/experience Working In Cross-functional Teams
Understanding of sterile and liquid products, particularly parenteral & biologics commercial manufacturing and
associated unit operations.
Understanding of primary packaging for parental and/ or lyophilization process is preferred
Understanding of Quality by Design (QbD), Design of Experiments (DOE), multivariate analysis, PAT, critical
process and material attributes and CQA's.
Working competency of Statistical Process Control and related tools (JMP/MiniTab/SAS).
Able to design and execute scientifically sound, hypothesis driven experiments
Skilled in writing and reviewing complex study plans and scientific reports.
Possess high level of familiarity with sterile product processing equipment and manufacturing facilities.
Overall knowledge of parenteral technology: aseptic processing, sterilization, isolator processing, lyophilization,
filter validation, pre-filled syringe operations, etc.
Strong understanding of project management systems and tools
Six Sigma Green/Black Belt certification desirable$72k-111k yearly est.25d ago
Associate Scientist
Synbio Technologies is looking for an Associate Scientist to join the production team, which focuses on developing and commercializing gene synthesis and sequencing platforms. This Associate Scientist will collaborate with the Business Development, Project Management, and Marketing team to deliver research projects and launch new products. Synbio Technologies is committed to discovering and developing cutting-edge DNA technologies for the advancement of life science, synthetic biology, drug discovery and development, diagnostics and precision medicine and digital information DNA storages, etc. Synbio Technologies has built a comprehensive DNA reading (sequencing), DNA writing and DNA editing platforms enabling us to aid customers in one-stop DNA solutions.$67k-98k yearly est.21d ago
Scientist Formulation
Scientist to join the team.$81k-123k yearly est.17d ago
Sr. Scientist, Coatings
We are currently seeking a Senior Scientist (Coatings Technology) to join our Product Development team. We hope you will join us and become an advocate for diversity and inclusion here at Benjamin Moore. Benjamin Moore & Co., a Berkshire Hathaway company, is a leading manufacturer of innovative, high-quality coatings for the architectural and light-duty industrial maintenance markets. At Benjamin Moore & Co, we don't just accept difference -- we celebrate it, we support it, and we thrive because it benefits our employees, our products, and our community. At Benjamin Moore, we believe diversity of culture, talent, and varying perspectives is key to a collaborative, innovative, and successful business. The Senior Scientist job is an exciting chance to join a team that promotes and recognizes innovation.$125k-158k yearly est.9d ago
Postdoctoral Researcher
The INSPIRE Program is based in the Piscataway Campus of Rutgers and is open to postdocs applying to do research at any Rutgers campus (Newark, Piscataway, New Brunswick, Camden). The Rutgers INSPIRE program is funded by the NIH IRACDA Program to train Postdoctoral Fellows in the Biomedical Sciences who are interested in a successful faculty career$49k-61k yearly est.18d ago
Urgent Need for Analytical Scientist @Contract to Hire
Location : Warren, NJ The Analytical Scientist will be part of a team of drug development professionals responsible for the continued development and regulatory approval of thin film drug products containing a wide range of therapeutic compounds.$74k-108k yearly est.3d ago
Associate Formulation Scientist
This exciting opportunity as an Associate Formulation Scientist offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance, vision insurance, paid PTO etc. Then this Associate Formulation Scientist opportunity could be the right fit for you.$50k-55k yearly4d ago
About Ascendia Pharmaceuticals:
Ascendia is a specialty pharmaceutical Research and Development CDMO company dedicated to developing enhanced formulations of existing drug products, and enabling formulations for pre-clinical and clinical stage drug candidates. Ascendia specializes in creating formulations for poorly-water soluble molecules using nano-particle technologies. Ascendia assesses the feasibility of a broad array of formulation options in order to improve a drug's bioavailability and solubility. Ascendia's technologies include nano-emulsions, amorphous solid dispersions, nano-particles, injectable, and oral controlled release. Ascendia provides development and testing services - from discovery-stage molecules to life-cycle-management projects - creating formulation solutions with enhanced biopharmaceutical properties suitable for clinical scale-up.
The mission of our company is to provide customized formulation solutions to “salvage” difficult compounds and to create advanced medicines to help patients “prevail” over their disease and enhance quality of life.
About the Position:
The qualified candidate will take an active role in supporting drug development by applying a variety of analytical methodologies to support physical and chemical characterization of drug substances (including raw materials and intermediates), biologics, and drug products. Working knowledge of analytical (e.g., HPLC-UV, HPLC-MS, GC-MS, spectroscopy) and physical chemical techniques (e.g., particle size, dissolution) used for the characterization of pharmaceutical substances and products is desired. Hand-on experience in HPLC method development and biological characterization is highly desired. Position level varies from bench chemist to principle scientist, depending on experience.
Principal Responsibilities:
The individual will be responsible for performing laboratory work in support of analytical testing of pharmaceutical projects, and relevant experience with the following analytical methodologies: chromatography, dissolution, KF, particle size will be desirable. Job responsibilities may include analytical method development and validation; stability and release testing; testing to support pharmaceutical development efforts; direct interaction with project team members, including presentation of data; critical review of data; preparation of technical reports; and evaluation of new instrumentation or analytical techniques. The candidate must be able to interact effectively with peers and leaders as part of a multi-disciplinary team and work in a fast-paced environment. Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.
Qualifications
The position requires a B.S, M.S. or Ph.D. in Pharmaceutical Chemistry, Analytical Chemistry, Biology, Bioengineering, Chemistry, or Pharmaceutical Sciences with relevant working experience in pharmaceutical industry.
Working knowledge in analytical method development and validation under cGMP environment, esp biological characterization is highly desired.
Experience with a wide-variety of software and information systems (e.g. Empower, ChemStation, or LIMS).
Experience in problem-solving skills and instrument trouble-shooting.
Good oral and written communication skills and the ability to write and review technical reports and scientific papers are desired.
Working knowledge of pharmaceutical product development, CMC regulatory requirements, project management; and capability to collaborate with colleagues.
EEO/AA M/F/V/D
$79k-113k yearly est.18d ago
Engineering - Assistant/Associate Scientist
Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. The Assistant/Associate Scientist contract position will be in the Downstream Process Development group in Summit, NJ, and be responsible for the development of scalable purification processes, process characterization, Tox material production, and tech transfer to GMP facilities for clinical/commercial manufacturing. Location: Summit, NJ 07901 Title: Engineering - Assistant/Associate Scientist At Net2Source, we believe everyone has an opportunity to lead.$35-40 hourly25d ago
Translational Bioinformatics Research Scientist
Project Description: Our client is seeking a passionate scientist to join their Disease Strategy and Late-Stage Hematology team in the Translational Bioinformatics group.$89k-130k yearly est.8d ago
Scientist
Location: Kenilworth, NJ With expanding biologics pipeline, the Biologics Process Development organization within client & Co. is seeking a highly a motivated scientist to support testing and implementation of a cell culture media platform. Title: Upstream Processing Scientist - II (Associate)$82k-117k yearly est.25d ago
Sr. Scientist
Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Synectics offers eligible employees and their dependents a dental plan through MetLife. Synectics offers eligible employees vision insurance through VSP. Premiums are subsidized by Synectics.$107k-151k yearly est.4d ago
position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in$74k-111k yearly est.17d ago
Senior Analytical Scientist
The Analytical Scientist will be part of a team of drug development professionals responsible for the continued development and regulatory approval of thin film drug products containing a wide range of therapeutic compounds.$79k-112k yearly est.4d ago
How much does a Senior Principal Scientist earn in Readington, NJ?
The average senior principal scientist in Readington, NJ earns between $90,000 and $178,000 annually. This compares to the national average senior principal scientist range of $83,000 to $169,000.
$126,000
What is the job market like for senior principal scientists in Readington, NJ?
You can compare the number of available jobs in Readington to the number of senior principal scientist jobs in surrounding cities.
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