- UpvoteDownvoteShare Job
- Suggest Revision
The Director of Purification Development for Pre-pivotal Biologics will be responsible for leading molecular assessment, purification development, process transfer and implementation at manufacturing facilities to produce drug substances for toxicology and pre-pivotal clinical studies.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Allogene is seeking a Senior Director, CMC Regulatory Affairs to provide support for products under development and lead CMC product strategy and provide regulatory direction to quality, manufacturing/tech ops and supply chain teams.
$220,000 - $280,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
GENEWIZ is a leading global genomics service company and trusted provider for DNA sequencing, gene synthesis, molecular biology, next generation sequencing, bioinformatics, and GLP regulatory services.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Reporting to the Executive Director, Process Development and Manufacturing, the Associate Director or Director, Process Development and Manufacturing is responsible for the design and execution of experiments to support process development and provides technical oversight of contract development and manufacturing organizations (CDMOs) for small molecule programs ranging from research phase to clinical development and eventually commercial production.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Thorough understanding and working experience in drug substance development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
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
The successful candidate will join a highly skilled process development within the UCSF Cellularl Therapy Group that is pushing the boundaries of medicine by developing, engineering, and manufacturing promising new cell therapy products for a variety of indications including cancer, autoimmunity, infectious disease, and inherited hematologic and immune disorders.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Contribute to the preparation and review of CMC (Chemistry, Manufacturing, and Controls) documentation, particularly focusing on the analytical sections required for regulatory filings(BLA/MAA), including post-approval submissions to US and EU regulatory bodies.
RemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Author CMC sections for regulatory filing, investigator brochure and study protocol. Strong scientific knowledge and understanding of product development with relevance to pharmaceutical manufacturing including API chemical synthesis, drug product manufacturing, and packaging.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Works collaboratively with Clinical Operations, Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory, Outsourced Manufacturing and Project Management partners to develop optimal supply strategies and ensure on time delivery of clinical supplies to initiate and resupply studies with investigational medicinal product (IMP.
$65 - $80 an hourExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
- Suggest Revision
What You Will AchieveYou will help Pfizer develop and implement chemistry, manufacturing and controls (CMC) regulatory strategies for small and/or large molecules to meet global regulatory requirements throughout the life cycle.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Provide strategic thought leadership in collaborating with Roche's SAP Serialization Enterprise Team to architect, design, build and test a custom solution that integrates with Client's existing SAP Serialization Enterprise Solution meeting Client's Manufacturing, Contract Manufacturing Organization, Product Distribution Center, and regulatory business requirements.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
IT Manufacturing Domain (Qualification implementation and Advisory in Veeva QMS) Support the on-going regulatory compliance of the IT components for defined services to ensure the proper integration and functionality of the Veeva QMS system.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
We are seeking an innovative and highly motivated Principal Scientist, Scientific Affairs who will contribute significantly to the development and continued growth of our advanced cell therapy manufacturing platform.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Proficiency in data analysis and interpretation using FlowJo, FACSuite, FACS Diva, and SpectroFlo. Familiarity with cGMPs and relevant Regulatory Guidance documents preferred Experience in flow cytometry assay development, qualification, and tech transfer preferred.
ExpandApply NowActive JobUpdated Yesterday
regulatory manufacturing jobs in South San Francisco, CA
FEATURED BLOG POSTS
In-House vs Outsourcing Recruiting: Which is Better?
When looking at in-house vs outsourcing recruiting, it is important to nail down the benefits for each and whether those benefits outweigh the risks that follow.
How to Write a Short Bio
First impressions can be tricky. When meeting someone in person, it’s likely you have an elevator speech. These short, practiced introductions can help you share more about who you are, what you do for work and other facts about you. While this works well in a live, in-person context, there are many cases where professionals “meet” someone via written form - like social media, a resume, or published work. In these cases, your bio works as your first impression. So, here’s a step-by-step guide on how to write a short bio.
How to Effectively Recruit Employees
Today, hiring and retaining talent looks much different than it did only two or three years ago. Financial instability and the strain on our mental health brought on by the pandemic has made everyone more wary and selective of their workplace and employer. Whereas in the past people might have prioritized promotions and financial reward, today they look at other factors such as workplace flexibility, personal fulfillment and values alignment.
Paralegal Resume Templates, Examples, and Tips
A paralegal job is a great stepping stone to a legal career. As an expert in legal research, paralegals must be organized, strong writers, and a team player with others who require the assistance of the paralegal’s work. Sometimes known as legal assistants, paralegals are a critical part of a legal team’s work. Paralegals work across law firms, corporations, nonprofits, and government agencies.
Operations Job Titles for Entry, Mid, and Senior-Level Positions
An operations team can take on many functions within a business. With wide-ranging responsibilities come wide-ranging job titles. This means that you have to be more vigilant in your job search. On one hand, the perfect job might be hidden under a title you might not expect. Meanwhile, operations titles that you’re used to looking at may mean something different at a given organization depending on their structure.
How to Automate Your Job Search
The internet is ripe with career professionals urging you to be aggressive in your networking and application strategies to land a job. But at what expense? Your sanity? Peace of mind? Energy? Free time? When the job search gets overwhelming—as it inevitably will—leverage automation to take the most tedious tasks off your plate. Here are seven ways to do it.
How To Request Accommodations at Work (According to Someone Who’s Done It)
Doing a job for eight hours a day, five days a week is exhausting for anyone. But for those with a disability or chronic pain, it can be especially taxing—something must change. Asking for reasonable accommodations at work can feel tricky, especially if you’re new to the job. Under the Americans with Disabilities Act (ADA), physical disabilities, health conditions, and symptoms of mental health are all valid workplace accommodations. When you request accommodations, it means that your condition is impacting your ability to perform at work.