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The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.
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Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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Reporting to the Vice President, CMC Regulatory, CARGO is seeking an Associate Director, CMC Regulatory to help progress development of our cell-based gene therapy portfolio. 10+ years of experience working directly in regulatory CMC or in a relevant technical development discipline, such as process development, analytical development, or quality assurance, including at least 6 years' experience directly in CMC regulatory.
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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
$295,290 - $382,140ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The position is responsible for product development, technology transfer and overall management of CMC activities related to ensuring robust development and reliable GMP supply of oligonucleotide conjugates and intermediates.
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Whether you will spend your day in an office cubicle, operating a crane or running the melt shop at one of our mills, at CMC, you'll get the training and support from your team that you need to excel in your role and reach your full potential.
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Certified Municipal Clerk Program (CMC) designation or enrollment. Certified Municipal Clerk (CMC) by International Institute of Municipal Clerks. Principles and practices of municipal government administration.
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The primary focus of this position will be to lead the Seattle-based CMC lab function which includes CHO cell culture manufacturing, protein purification, and biophysical characterization. Icosavax seeks a Director, Translational CMC with a strong background in large molecule process development and analytical development to advance our vaccine programs.
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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The role of a Psychiatric Mental Health Nurse Practitioners (PMHNP) at CMC of PA is to provide direct one-on-one high quality counseling, medication evaluation and management, to a range of clients with mental health diagnoses.
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If you're ready to reimagine ways to make the steel industry more sustainable, reinforce the bridges and roadways connecting our communities, and do meaningful work, you're ready to join CMC. Apply today and start moving your career - and our world - forward.
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The Associate Director Regulatory Affairs CMC is responsible for CMC regulatory support to enable clinical development, marketing authorization, manufacture and distribution of clinical supplies and commercial products.
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Develop and execute global CMC regulatory strategies in alignment with overall product development and registration plans. Provide CMC regulatory guidance and support to internal teams including manufacturing/MSAT, Quality Assurance, and R&D.
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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 yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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The successful candidate should have strong expertise in immuno-oncology and will be focused on focus on the development of fit-for-purpose CMC assays using flow cytometry and cell-based immunoassays, to characterize engineered TCR-T cell drug substance and drug product.
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Virtual Reality Job Interviews
With the advent of desktop computers, the arduous task of scouring through weekly job classifieds became a thing of the past. The mid-1990s brought about a new era where job seekers could easily search and apply for jobs online. The introduction of AOL's Instant Messaging feature provided an even faster means for employers and candidates to communicate and schedule interviews. As smartphones became more pervasive in the early 2000s, hiring managers increasingly used phone calls for screening and interviewing candidates. Despite this trend, over 80% of interviews still took place in person.
A Potential TikTok Ban?!
As you may already know, there has been a lot of talk lately about the possibility of a TikTok ban. While this has not yet come to fruition, it's important to consider the implications this could have for businesses and recruiters who rely on TikTok as a platform to market their brand, recruit new talent, and connect with their audience.
The Effects of Workplace Racism and Sexism
One day it's a covert statement to a mother returning to work after maternity leave. Another day it's a lingering gaze at an employee enjoying a culturally rich meal. These microaggressions (or sometimes macroaggressions) can take an employee from a confident, high-performer to one that feels insecure being themselves at work. Your employees engage with people with different ideas and feel most comfortable and valued when they can work without losing their cultural, racial, and gender identity. While most employers know this, why have workplace racism and sexism often been neglected?
When Rage Applying Strikes: How to Identify Unserious Candidates
As the job market remains highly competitive, we have seen a surge in "rage applying." This is when candidates apply to multiple jobs, often without considering whether they are truly interested in the role. Rage applying goes hand-in-hand with quiet quitting. Often, employees want to entertain the thoughts and feelings of leaving their job, but they aren't necessarily serious about leaving yet. Meanwhile, other employees engaging in this trend are actually trying to find a better role. As a recruiter, it can be hard to identify who are the real applicants in a sea full of quiet quitters, but understanding rage applying and identifying red flags will certainly help.
How to Increase Job Ad Exposure
In today's competitive job market, writing quality job ads is critical for attracting top talent to your organization. While networking and candidate referrals are prime real estate for finding qualified candidates, nothing beats the tried-and-true method of writing an extraordinary job ad. But while writing a great job ad is the first step, what's more important is increasing visibility. You could have the most detailed, well-written ad on the internet, but if no one sees it, then you are wasting time (and potentially money!). Employers often believe that job boards are the root of the problem, but you can learn how to increase job ad exposure by tweaking a few steps of your recruitment process.
How to Navigate Hiring Out of State
The job market has shifted significantly in recent years. The accelerated adoption of technology has not only pushed many companies into remote working arrangements but also increased the availability of supporting tools and technologies (i.e., video conferencing and collaboration software).
Building a Candidate Pipeline Through Internships
Building a candidate pipeline through a great internship program for local college students and recent graduates at local universities is a great and cost-effective way to attract and retain top talent. By offering meaningful and impactful work experiences, regular feedback, coaching, and mentorship, you can create a positive internship experience that will make your organization a sought-after destination for future employees. This not only benefits the organization in the short-term but also in the long-term, as you'll have a pool of well-trained and experienced candidates who may be interested in full-time employment once they graduate. Furthermore, building relationships with local universities and college students can increase brand awareness and build a positive reputation for your organization in the local community.