Full-Time
Associate Director
CMO Operations
Posted on 12/11/2024
Legend Biotech
1,001-5,000 employees
Develops and commercializes cell therapies
Senior, Expert
Bridgewater Township, NJ, USA
The position is onsite in Raritan, NJ.
You match the following Legend Biotech's candidate preferences
Employers are more likely to interview you if you match these preferences:
- BS/MS is required, in related technical disciplines: engineering, biology, chemistry, pharmaceutics etc.
- Minimum 8 years for BS/MS, 5 years for PhD of industrial biologics manufacturing experience, autologous cell therapy manufacture experience is highly desirable.
- Significant experience of proposal review, contract negotiation and independently managing CMO management is essential.
- Highly Organized, detail oriented and collaborative
- Experience in a fast-paced and dynamic environment
- Excellent time-management, communication skills and business acumen.
- Working with integrated business planning team (IBP) and Vein to vein team (V2V) to plan, schedule and track the manufacture of autologous cell product batches at CMO
- Monitor the progress of product batches, identify and escalate deviation and other manufacture issues
- Collect, calculate the KPI, and mitigate/remedy gaps of the CMO manufacture performance
- Collaborating with procurement team/financial team on new orders, invoice and payment
- Collaborating with MSAT team on deviation investigation, process change, ramp up activities
- Provide timely and accurate update on the CMO performance to the manager and cross functional stakeholders.
- autologous cell therapy manufacture experience is highly desirable.
Legend Biotech develops and commercializes cell therapies aimed at treating serious diseases, particularly cancers like hematological malignancies and solid tumors. Their approach is technology agnostic, allowing them to explore various methods to find effective treatments. The company operates in the personalized medicine sector, focusing on discovering, developing, and bringing new therapies to market. They generate revenue through licensing and selling their therapies, including CAR-T therapies, which involve modifying a patient's own cells to combat cancer. Legend Biotech emphasizes transparency with investors, regularly updating them on financial results and business developments.
Company Size
1,001-5,000
Company Stage
IPO
Total Funding
$146.4M
Headquarters
Franklin Township, New Jersey
Founded
2014
Simplify's Take
What believers are saying
- Recent FDA and European approvals for CARVYKTI® expand its market reach in multiple myeloma.
- New R&D facility in Philadelphia boosts innovation in next-generation cell therapies.
- Alan Bash's appointment could accelerate CARVYKTI®'s growth and market penetration.
What critics are saying
- Increased competition from Amgen's Imdelltra may impact CAR-T therapy focus.
- Collaboration with Multiply Labs may face technological challenges, delaying production timelines.
- Financial strain from new R&D facility could affect operational focus if advancements lag.
What makes Legend Biotech unique
- Legend Biotech focuses on novel cell therapies for oncology, including CAR-T and NK cells.
- The company is technology agnostic, exploring multiple platforms for effective cancer treatments.
- Legend Biotech's CARVYKTI® is the first BCMA-targeted CAR-T therapy approved for second-line use.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
Paid Sick Leave
Paid Holidays
Remote Work Options
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
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↓ -1%Legend Biotech Corporation on Tuesday said it appointed Alan Bash as president of its CAR-T product CARVYKTI®. In this newly created role, Bash will be responsible for managing the continued growth of CARVYKTI®, overseeing the Somerset-based firm’s commercial, technical operations, and quality functions of the franchise.“This expansion in our leadership structure is on the heels of CARVYKTI’s recent successes, including recent approvals from the U.S. Food and Drug Administration and European Commission for label expansion,” Ying Huang, chief executive officer of Legend Biotech said. “Legend Biotech welcomes Alan and is confident that his wealth of operational knowledge in oncology will help further strengthen the Company’s leadership role in the treatment of multiple myeloma.”Previously, Bash served as chief executive officer for two oncology-focused biotech companies, most recently at ZielBio, and before that, as president and CEO at Checkmate Pharmaceuticals. He also had a 23-year career with Bristol Myers Squibb, where he held various leadership positions across all major therapeutic areas—including oncology—driving the U.S. launch of Opdivo® and the expansion of additional cancer treatments such as Yervoy® and Erbitux ®.Bash contributed to several blockbuster products in collaboration with other companies, including Abilify® with Otsuka and Eliquis® with Pfizer.“As the fastest launched CAR-T product on the market, CARVYKTI has already produced impressive momentum,” Bash said
SOMERSET, N.J., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced the appointment of Alan Bash as the Company’s President of CARVYKTI®. In this newly created role, Mr. Bash will be responsible for managing the continued growth of CARVYKTI®, overseeing Legend Biotech’s commercial, technical operations, and quality functions of the franchise.“This expansion in our leadership structure is on the heels of CARVYKTI’s recent successes, including recent approvals from the U.S. Food and Drug Administration and European Commission for label expansion,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “Legend Biotech welcomes Alan and is confident that his wealth of operational knowledge in oncology will help further strengthen the Company’s leadership role in the treatment of multiple myeloma.”Mr
With a global workforce of 1,500 employees, including 350 in R&D, Legend is expanding its manufacturing capabilities with new facilities in New Jersey and beyond.
SOMERSET, N.J., Oct. 03, 2024 (GLOBE NEWSWIRE) - Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), announced it is establishing a new, state-of-the-art research and development (R&D) facility in Philadelphia, Pennsylvania, to advance its portfolio of next-generation cell therapies.
Multiply Labs, a robotics company specializing in automated manufacturing systems for individualized drugs, has announced a collaboration with Legend Biotech (NASDAQ: LEGN).
In addition to these appointments, Legend Biotech has appointed Dr. Peter Salovey, Ph.D., President Emeritus of Yale University, as an Independent Director on August 8, 2024.
Cell engineering company MaxCyte (Nasdaq: MXCT) has entered into a strategic platform license agreement with Legend Biotech (Nasdaq: LEGN), another company focused on cell therapies.
Pictured: Amgen's office in Tampa, Florida/iStock, JHVEPhotoThe FDA on Thursday approved Amgen’s bispecific T-cell engager tarlatamab, which will now carry the brand name Imdelltra, for the treatment of extensive-stage small lung cancer in patients with disease progression on or after platinum chemotherapy.Imdelltra is approved under the regulator’s accelerated pathway based on treatment response and duration of response data. To maintain the approval, Amgen will need to verify Imdelltra’s clinical benefits in a Phase III confirmatory trial. The FDA also gave Imdelltra a boxed warning for cytokine release syndrome and neurologic toxicity.Jay Bradner, CSO and executive vice president of RD at Amgen, called Thursday’s regulatory win a “pivotal moment” for patients with extensive-stage small lung cancer (ES-SCLC), with Imdelltra a “transformative option demonstrating long-lasting responses,” especially in patients exposed to prior treatments.Designed as an intravenous infusion, Imdelltra is a first-in-class bispecific antibody that can bind to both the DLL3 protein on tumor cells and the CD3 antigen on T cells. This mechanism of action allows Imdelltra to activate the body’s immune players and induce the destruction of DLL3-expressing cancer cells.DLL3 is expressed in 85% to 96% of SCLC cases but the protein is rarely found on healthy cells, according to Amgen. The company is also developing tarlatamab for neuroendocrine prostate cancer, for which the candidate is currently in Phase I.Thursday’s accelerated approval was backed by data from the Phase II DeLLphi-301 trial, which administered Imdelltra at a 10-mg or 100-mg dose every two weeks. In October 2023, Amgen published data from the mid-stage study in The New England Journal of Medicine, touting an objective response rate of 40% and 32% in the 10-mg and 100-mg dose groups, respectively.Of those with objective response to Imdelltra, 59% sustained the response for a median duration of at least six months
SOMERSET, N.J.--(BUSINESS WIRE)--Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, announced today that the European Commission (EC) has granted approval of CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), have demonstrated disease progression on the last therapy and are refractory to lenalidomide. “The European Commission’s approval of CARVYKTI has the potential to transform the treatment paradigm for patients battling multiple myeloma by bringing our novel therapy to them earlier in the course of this incurable disease,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “This approval is a testament to our innovative science and galvanizes our efforts to provide new options that will improve outcomes for patients and give hope to them and their families.”. The European approval is based on positive results from the CARTITUDE-4 study, which demonstrated that CARVYKTI® resulted in statistically significant and clinically meaningful improvement of progression-free survival compared to two standard of care treatment regimens, pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd), in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy
SOMERSET, N.J.--(BUSINESS WIRE)--Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, announced today the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI), and an immunomodulatory agent (IMiD), and are refractory to lenalidomide.1 CARVYKTI® is the first and only B-cell Maturation Antigen (BCMA) targeted therapy, including CAR-T therapies, bispecific antibodies, and antibody-drug conjugates (ADCs), approved starting in the second-line of treatment for patients with multiple myeloma. “The expanded label of CARVYKTI has the potential to transform the treatment paradigm for multiple myeloma by providing patients and physicians with a personalized immunotherapy that can be used earlier in the treatment regimen. Multiple myeloma is an incurable and progressive hematologic cancer that causes patients to relapse and become refractory to treatment, so new, innovative options are desperately needed,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “We are committed to improving the lives of patients battling blood cancer and will continue to work towards developing cellular therapies that bring us closer to a cure.”. The FDA approval is based on positive results from the CARTITUDE-4 study, which demonstrated that CARVYKTI® resulted in statistically significant and clinically meaningful improvement of progression-free survival compared to two standard of care treatment regimens, pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd), in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.1 This approval follows a unanimous (11 to 0) recommendation from the FDA Oncologic Drugs Advisory Committee (ODAC) in support of CARVYKTI® in earlier lines of treatment