100% onsite - Oceanside, CA Pay Rate: $45.00 Role: Senior Research Associate - Biologics Drug Product Development (BDPD). BDPD is responsible to develop and characterize formulations and processes for all biologic drug products in pivotal (P 3) and commercial stages; also responsible for short / long term stability assessments, technology transfers to clinical and commercial sites, manufacturing support, in-use and compatibility to support clinical studies. Seeking motivated, team-oriented indiv... more details
Description:
100% onsite – Oceanside, CA Pay Rate: $45.00 Role: Senior Research Associate – Biologics Drug Product Development (BDPD).
BDPD is responsible to develop and characterize formulations and processes for all biologic drug products in pivotal (P3) and commercial stages; also responsible for short / long term stability assessments, technology transfers to clinical and commercial sites, manufacturing support, in-use and compatibility to support clinical studies. Seeking motivated, team-oriented individuals with scientific experience in laboratory work related to biologics.
Essential Duties and Job Functions:
Perform experiments pertaining to:
Protein formulation/stability of various dosage forms (liquid/lyophilized) and configurations (vial/syringe), employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods
Scale-down/-up of biologics drug product processes
In-use stability and administration
Author protocols, technical summary reports/memos and tech transfer documentation defining the manufacturing process and parameters
Review Master Batch Records for accuracy and trend process data supporting process development or fill/finish manufacturing operations
Execute studies in support of drug product technology transfers to clinical and commercial manufacturing sites
Be an effective communicator of ideas, project goals and results at departments/meetings in both written and presentation format.
Be self-motivated, organized, thrive in team settings and enjoy scientific investigation and thinking, as well as be familiar with the relevant technical literature.
Knowledge, Experience and Skills:
Degree in Chemical/Biochemical Engineering (or a related engineering discipline) or Pharmaceutical Sciences, and relevant industry experience that demonstrates expertise in drug product development as well as sustained excellence in performance and accomplishments that align to company goals.
Excellent communication (both verbal and technical) and interpersonal skills are required.
Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy.
Minimum Qualifications:
A minimum of 5+ years of experience with BS degree or 3+ years of experience with MS degree in Pharmaceutical Sciences, Biology, Biochemistry, Biochemical Engineering or a related scientific discipline.
A basic understanding of formulation and drug product process development for biologics (antibodies, fusion proteins, bi-specifics, vaccines, antibody drug conjugates, etc.).
Previous experience interfacing with biologics drug product manufacturing sites and providing technical support during engineering runs/GMP operations is a plus.
Must Have Requirements/Skills:
Experience working with Biologics molecules (proteins, mAbs); experience working with ADC is a plus
Protein formulation/stability of various dosage forms (liquid/lyophilized) employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods, analytical data analysis
Experience with some scale-down/-up of biologics drug product process development activities; buffer preparations, testing using compendial methods (osmo, protein conc., pH, etc.) and UF/DF is a plus
Nice to Have Requirements/Skills
Presentation and Documentations (ELNs, technical reports, MEMO, etc)
good understanding / experience in biologics drug product process (freeze-thaw, filtration, mixing, filling, lyophilization)
some understanding of in-use stability and drug administration process and associated challenges (IV bags, subcutaneous injections)
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
We would like to take a second to Welcome You to Job Abstracts, the nation’s largest Pure Job Board. With over 3.1 million job listings from 15,000+ Companies & Organizations, we help job searchers find careers that match their interests. As an anonymous user, you have probably discovered how easy our system is to use. However, you have just scratched the surface of what we can offer.
We encourage you to Register so you can use our most powerful features: searching with multiple terms, setting up multiple locations, establishing favorite companies, and accessing your search history. If you find a job you like, you can apply directly for it, and then, keep notes on it. We will also keep a lookout for jobs that match your search terms and email you when we find something you may like.
You can register for free and the system is free to use. If you like our system so far, click on Register and unlock the power required by serious job searchers.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.