- UpvoteDownvoteShare Job
- Suggest Revision
The primary duty of the Associate Director, Regulatory Affairs is to support regulatory strategy for product development and manufacturing activities for the Cell & Gene Therapy sites to ensure compliance with GMP regulations and to support preparation and filing of regulatory submissions for clients.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Position Purpose:The Business Development Manager role is designed to establish and grow new partnerships with Cell and Gene Therapy and adjacent Life Science customers by working alongside them at their facilities and identifying potential improvements to ensure regulatory compliance, improve product quality and identify safety and operational efficiency opportunities.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases. The GMP Mechanical Technician will be responsible for detailing all work in CMMS, and equipment logbooks.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Will prepare for and lead regulatory meetings, designing regulatory compliance strategy to ensure compliance with GMP regulations, assisting in training of regulatory department and cross-functional areas in regulatory requirements.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Key Duties and Responsibilities:Work with colleagues across Vertex, including Process Development and Vertex Cell and Gene Therapy, Device Groups, Pharmaceutical Sciences, Packaging, and Commercial to bridge device manufacturing technology from development into commercialization and commercial manufacturing.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. The Associate Director, Regulatory Affairs will be interpreting and evaluating reports and other documents to be used in all typical regulatory submissions, reviewing new and revised SOPs and guidance pertaining to Regulatory Affairs and regulatory compliance.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
We seek an experienced Analyst, QC Bioassay / Biochemistry to support establishing new commercial-level in-house GMP testing laboratories performing release and stability testing for multiple stages of our gene therapy and immune oncology products.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
The QC Analyst will support the gene therapy program pipeline including but not limited to routine GMP microbiological testing of AAV vector such as bioburden and endotoxin. This analyst also will support microbiological water sample testing in support of the GMP manufacturing facility.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Responsibilities will also include supporting functions for all clinical and commercial drug manufacturing of gene therapy products, leading automation activates during tech transfers of new products and provide support throughout the companies manufacturing campaigns.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Managing new multi-disciplinary project converting core-and-shell building into new EMA GMP rated cell and gene therapy facility. Managing new multi-disciplinary project converting core-and-shell building into new EMA GMP rated biopharmaceutical facility.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
A publication history in the fields of molecular/cell biology, bioengineering, biomedical engineering, cell and gene therapy, or other cell therapy/biology related field. Experience in cell therapy or regenerative medicine research, experience in GMP/GLP-compliant cell manufacturing production processes is a plus.
$47,476 - $74,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Sound knowledge on GMP operations and quality in biotechnology drug substance or similar (Cell and Gene Therapy / Aseptic) Strong experience working on GMP clinical and commercial operations as well a GMP guidelines including but not limited to FDA and EMA.
ExpandApply NowActive JobUpdated Today
gene therapy gmp jobs
FEATURED BLOG POSTS
Recruiting in a Recession: Hard Truths That Talent Acquisition Experts Must Accept
The summer had economists from around the globe embroiled in a debate about a possible recession coming in the next few years (or months). As of October 2022, the U.S. Labor Department data put the current inflation rate at 7.7%. The recent layoffs in the tech industry are just the first of what is soon to be a string of cutbacks by companies looking to save costs. For recruiters, this means freezes in hiring and fewer openings. It will also include the uphill task of finding the best candidates for them from the coming influx of recently laid-off job seekers. Now is probably a good time to brace for tough times in the next few years in the talent acquisition industry. To survive and thrive recruiting in a recession, here are some hard truths you will need to accept.
10 Importancies of Setting Realistic Goals
We’ve all heard how important it is to set professional and personal goals. Developing and establishing goals keeps us motivated and moving forward in life. But not all goals are created equal. If you’re chasing goals that are too lofty, you’ll end up disappointed when you cannot reach them. Setting goals that are achievable and measurable is the key to success.
Email Etiquette Principles - Why is it Important
Why is email etiquette important? Let's imagine you're hiring for a new role, and you’ve just received the email below.
10 Reasons HR is Important to an Organization
"Nothing we do is more important than hiring and developing people."
7 Importances of Organizational Culture and How to Build It
The world of work has drastically changed in the past few years. Where a good salary and a nice office might have been enough to attract talent in the past, employees today expect flexibility, growth opportunities, and a healthy work environment. In fact, 77% of applicants say they’d consider a company’s culture before applying for a job.
Collaborative Recruiting: The Key to a Better Talent Acquisition Strategy
Talent acquisition is a multi-stage process where candidates undergo various application steps before getting hired. The unfortunate reality is that it is a labor-intense system, with the hiring manager and recruiter often handling all of the work on their own. Ask any one of them, and you will hear about the overabundance of applications and the demanding task of filtering through them to find the best candidates. The quality of talent suffers under the weight of all that work on one person's hands. It's not easy, but as many companies are starting to realize, there is a better way. The future of talent acquisition lies in collaborative recruiting!
4 Talent Acquisition Trends Going Into 2023
For better or worse, a side effect of the COVID-19 pandemic was a marked shift in talent acquisition practices worldwide. With the struggle to retain talent that began in 2020, companies have had to rethink recruitment strategies. The result has been new talent acquisition trends that are well on their way to becoming commonplace. These are the practices that are going to become even more widespread going into 2023.