- UpvoteDownvoteShare Job
- Suggest Revision
Maintaining the overall schedule of nonclinical studies system to track the entire workflow of nonclinical studies and archival of study-related materials; collaborate with the Biology, Medicinal Chemistry, and CMC leads to create and maintain timelines for nonclinical studies.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Act as the in-house validation expert and be responsible for CMC process validation including risk assessment, IPC, process characterization and validation following QbD guideline, as well as successful execution of PPQs and PAI to support BLA/MAA approval.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Key functions outside CMC include Quality, Regulatory, Clinical, Safety, Corporate Program Management, Project Team Leaders, Toxicology, DMPK, Preclinical functions, Budgeting and Forecasting, IP, and others as organization evolves.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Robust knowledge of both domestic and international chemistry, manufacturing, and controls (CMC) requirements associated with advanced cell therapy manufacturing. Collaborate with other development and CMC functions to ensure formulated product meets clinical and dosing requirements for different phases of product development.
$140,000 - $185,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Experience working effectively with CROs/CSPs. Expe rience with electronic Quality Management Systems and Trial Master File. Skills and Abilities A solid understanding of GCP, GLP, GMPs and CMC requirements is expected.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
SUMMARY/JOB PURPOSE: The Sr Scientist II, Analytical Development, Biologics CMC will support the CMC analytical development for multiple types of biologics including but not limited to antibody-drug conjugates (ADC), monoclonal antibodies and bispecifics.
$125,000 - $176,500 a yearExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Experience in biologics related CMC regulatory activities and in the support of manufacturing quality for biologics molecules. Subject Matter Expert in bioconjugation (ADC) process development and manufacturing in support of CMC activities.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Aloha CMC/CFGQSR Automations (KDS)eRestaurantPaytronixUltiProKronos Device ManagerKronos Workforce ManagerOloMeraki DashboardNCR Connected PaymentsOkta. Ability to maintain and configure systems using tools such as BatchPatch, Acronis, BigFix, InTune, Workspace One (Airwatch.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Develop and lead CMC Regulatory strategies for a portfolio of programs in development, including AAV gene therapies and small molecule drugs. Align CMC regulatory strategy to overall regulatory business strategy (e.g. viral vector upcoming process, raw material, shelf-life and analytical changes.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
THE ROLE Reporting to VP of CMC Ops, the Director of CMC Operations is responsible for drug substance development and manufacturing in support of clinical development and commercialization of 89bio's biologics pipeline drugs.
$205,000 - $225,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. GenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Extensive knowledge of drug development (Non clinical, clinical and CMC aspects), global pharmacovigilance principles, commercialization, and safety escalation governance processes, global regulatory authority operations, global rgulatory agency submission process, technical skills (such as Microsoft Outlook, Word, Excel, Power Point.
ExpandUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The candidate may work on any functional sub team depending on need, including CMC, Clinical, Research or Regulatory. Experience in a CMC discipline is preferred. This position will partner with functional sub-team leaders to lead project management activities for a cell therapy program sub-team, guiding the sub-team through preclinical and clinical development.
$145,000 - $175,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The candidate should have a passion for working collaboratively with nonclinical, clinical and CMC team members to enable building regulatory strategies for CRISPR-based therapeutics. Develop and execute global Regulatory strategies across nonclinical, clinical, quality and CMC functions, for gene editing therapies, ensuring alignment with corporate.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
PhD in chemistry, chemical engineering, biochemistry, pharmaceutics, or closely related discipline with 10+ years' relevant industry experience in a pharmaceutical CMC/GMP environment such as process development, formulation, etc.
ExpandApply NowActive JobUpdated Today
cmc job in Alameda, CA
FEATURED BLOG POSTS
What is a Policy of Non-Retaliation & How to Create One
Your company probably has many policies in place – anti-discrimination policies, equal opportunity policies, ethics policies, and so on. However, it is important to re-evaluate whether you have a policy that covers every situation. Say for instance one of your employees submit a complaint in good faith to their supervisor. To their surprise, they are met with retaliation, such as demotion, defamation, or even termination.
How to Take Your Careers Page to the Next Level
Your careers page deserves a lot of attention. It is not just another page on your website. It is a vital tool that could enhance your recruitment outcomes. But in order to do that, you have to make sure it's fully optimized.
When to Tell Your Boss You're Job Searching
The Bureau of Labor Statistics has found that individuals, on average, have 12.4 jobs throughout their working life. So regardless of where you are on the career ladder, it’s inevitable that at some point, you’ll begin looking for another job. That said, you might be wondering,
What Questions Can You Not Ask in an Interview?
It can be stressful to interview candidates to fill an open role at your company. Maybe your boss is on you to hire someone who’s absolutely perfect as soon as possible. Maybe you don’t have a ton of experience yet in conducting interviews. Whatever the case, there’s a lot to take under consideration when you’re the one in charge of interviewing. For instance, “What questions can you not ask in an interview?” may very well be running through your mind given its legal ramifications. Knowing exactly which interview questions are off-limits (and which are fine to ask) will boost your confidence as you continue to search for the ideal new hire.
How to Prepare to Be Fired - What You Need to Do
If you’re reading this, let me be the first to tell you how sorry I am. Getting fired feels crappy, disheartening, hurtful, and all the other bad, sad words. But here’s what I want you to do. First, let yourself fumble for a minute. Then, pick your head up — sometimes getting fired is a blessing in disguise. If you think termination is around the corner, we’ll teach you how to prepare to be fired and what to do next so you land somewhere even better.
How to Find a Job That Makes You Happy - 11 Concerning Facts
Do you ever feel like your life is like one of those rom-com movie scene openers? You know, the ones where the main character rolls out of bed, awakened by a casually upbeat theme song, sulks their way to the coffee pot, and then trudges toward their computer to begin yet another boring day at work?
How to Decline a Job Offer You Already Accepted
When you think about it, turning down a job offer is not the worst position you could be in. If you’ve been lucky enough to consider multiple job offers, well, then you’re lucky enough.