Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or a related ... Basic understanding of the drug development process, including preclinical development, CMC ...
Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or a related ... Basic understanding of the drug development process, including preclinical development, CMC ...
Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or a related ... Basic understanding of the drug development process, including preclinical development, CMC ...
Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or a related ... Basic understanding of the drug development process, including preclinical development, CMC ...
Decision Analytics Consultant- CMC
Manhattan, NY ยท On-site
$160K - $177K/yr
Bachelor's (and often graduate) degree in Chemical Engineering, Mechanical Engineering, Chemistry, Biotechnology or similar degree * 6-8 years of experience working in a pharmaceutical CMC ...
Decision Analytics Consultant- CMC
Manhattan, NY ยท On-site
$160K - $177K/yr
Bachelor's (and often graduate) degree in Chemical Engineering, Mechanical Engineering, Chemistry, Biotechnology or similar degree * 6-8 years of experience working in a pharmaceutical CMC ...
Sr. Scientist, Lentivirus Upstream Processing
Somerset, NJ ยท On-site
$96K - $132K/yr
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... in a timely manner. * Collaborate with cross-functional team members, including CMC Project ...
Sr. Scientist, Lentivirus Upstream Processing
Somerset, NJ ยท On-site
$96K - $132K/yr
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... in a timely manner. * Collaborate with cross-functional team members, including CMC Project ...
Associate Director - CMC Data Steward - DSCS Digital
Rahway, NJ ยท On-site
$129 - $203.10/hr
Experience operating in highly regulated pharmaceutical, biotechnology, or life sciences ... CMC Strategy, Cross-Functional Leadership, Data Governance, Data Lifecycle, Data Quality, Data ...
Associate Director - CMC Data Steward - DSCS Digital
Rahway, NJ ยท On-site
$129 - $203.10/hr
Experience operating in highly regulated pharmaceutical, biotechnology, or life sciences ... CMC Strategy, Cross-Functional Leadership, Data Governance, Data Lifecycle, Data Quality, Data ...
In collaboration with the Senior Leaders, CMC Project Manager, Project Leader, and other technical ... biotech or pharmaceutical setting. * Strong engineering knowledge of the principles of scaledown ...
In collaboration with the Senior Leaders, CMC Project Manager, Project Leader, and other technical ... biotech or pharmaceutical setting. * Strong engineering knowledge of the principles of scaledown ...
Experience operating in highly regulated pharmaceutical, biotechnology, or life sciences ... CMC Strategy, Cross-Functional Leadership, Data Governance, Data Lifecycle, Data Quality, Data ...
Experience operating in highly regulated pharmaceutical, biotechnology, or life sciences ... CMC Strategy, Cross-Functional Leadership, Data Governance, Data Lifecycle, Data Quality, Data ...
... in highly regulated pharmaceutical, biotechnology, or life sciences environments.Demonstrated ... CMC Strategy, Cross-Functional Leadership, Data Governance, Data Lifecycle, Data Quality, Data ...
... in highly regulated pharmaceutical, biotechnology, or life sciences environments.Demonstrated ... CMC Strategy, Cross-Functional Leadership, Data Governance, Data Lifecycle, Data Quality, Data ...
In collaboration with the Senior Leaders, CMC Project Manager, Project Leader, and other technical ... biotech or pharmaceutical setting * Deep technical hands-on experience in mammalian cell culture ...
In collaboration with the Senior Leaders, CMC Project Manager, Project Leader, and other technical ... biotech or pharmaceutical setting * Deep technical hands-on experience in mammalian cell culture ...
Senior Specialist - CMC Data Steward - DSCS Digital
Rahway, NJ ยท On-site
$117K - $184K/yr
Experience with enterprise systems such as SAP, LIMS, ELN, MES, Veeva, or similar platforms used in CMC operations. * 2+ years of experience in pharmaceutical, biotech, or life sciences environments ...
Senior Specialist - CMC Data Steward - DSCS Digital
Rahway, NJ ยท On-site
$117K - $184K/yr
Experience with enterprise systems such as SAP, LIMS, ELN, MES, Veeva, or similar platforms used in CMC operations. * 2+ years of experience in pharmaceutical, biotech, or life sciences environments ...
Director/Sr. Director of Drug Product CMC at EPM Scientific New York, NY
Manhattan, NY ยท On-site
$130 - $180/hr
We are partnered with a dynamic clinical-stage biotechnology company focused on developing ... Qualifications: * Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical ...
New
Director/Sr. Director of Drug Product CMC at EPM Scientific New York, NY
Manhattan, NY ยท On-site
$130 - $180/hr
We are partnered with a dynamic clinical-stage biotechnology company focused on developing ... Qualifications: * Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical ...
New
Global Viral Vector MSAT Lead
Raritan, NJ ยท Hybrid
Legend Biotech is seeking a Global Viral Vector MSAT Lead as part of the Global Manufacturing ... Minimum 10 years of in MSAT, tech transfer or process development. * Industrial biologics CMC ...
Global Viral Vector MSAT Lead
Raritan, NJ ยท Hybrid
Legend Biotech is seeking a Global Viral Vector MSAT Lead as part of the Global Manufacturing ... Minimum 10 years of in MSAT, tech transfer or process development. * Industrial biologics CMC ...
Sr. Scientist, Lentivirus Upstream Processing
$96K - $132K/yr
... in a timely manner. * Collaborate with cross-functional team members, including CMC Project ... a biotech or pharmaceutical setting * Hands-on experience in mammalian cell culture (HEK293 ...
Sr. Scientist, Lentivirus Upstream Processing
$96K - $132K/yr
... in a timely manner. * Collaborate with cross-functional team members, including CMC Project ... a biotech or pharmaceutical setting * Hands-on experience in mammalian cell culture (HEK293 ...
... CMC, Quality, Manufacturing, Commercial, Finance, and Business Development. * Drive cross ... Represent Legend Biotech in interactions with external partners, collaborators, investigators, key ...
... CMC, Quality, Manufacturing, Commercial, Finance, and Business Development. * Drive cross ... Represent Legend Biotech in interactions with external partners, collaborators, investigators, key ...
... CMC, Quality, Manufacturing, Commercial, Finance, and Business Development. * Drive cross ... Represent Legend Biotech in interactions with external partners, collaborators, investigators, key ...
... CMC, Quality, Manufacturing, Commercial, Finance, and Business Development. * Drive cross ... Represent Legend Biotech in interactions with external partners, collaborators, investigators, key ...
... in Somerset, NJ . Role Overview Legend Biotech is seeking an experienced and driven Manager/Sr. ... The successful candidate will translate clinical and CMC needs into executable supply plans, ensure ...
... in Somerset, NJ . Role Overview Legend Biotech is seeking an experienced and driven Manager/Sr. ... The successful candidate will translate clinical and CMC needs into executable supply plans, ensure ...
Director Drug Product Development
$195K - $230K/yr
In-depth knowledge and hands-on experience leading drug product development and CMC activities for small molecule programs in a clinical-stage biotechnology or pharmaceutical environment.
Quick apply
Director Drug Product Development
$195K - $230K/yr
In-depth knowledge and hands-on experience leading drug product development and CMC activities for small molecule programs in a clinical-stage biotechnology or pharmaceutical environment.
... in Somerset, NJ . Role Overview Legend Biotech is seeking an experienced and driven Manager/Sr. ... The successful candidate will translate clinical and CMC needs into executable supply plans, ensure ...
... in Somerset, NJ . Role Overview Legend Biotech is seeking an experienced and driven Manager/Sr. ... The successful candidate will translate clinical and CMC needs into executable supply plans, ensure ...
Principal Bioinformatician
Somerset, NJ ยท On-site
... Biotech is seeking a Principal Bioinformatician as part of the Early Drug Development team based in ... Partner closely with Translational scientists, Clinical Development, Research and CMC teams, CROs ...
Principal Bioinformatician
Somerset, NJ ยท On-site
... Biotech is seeking a Principal Bioinformatician as part of the Early Drug Development team based in ... Partner closely with Translational scientists, Clinical Development, Research and CMC teams, CROs ...
Principal Bioinformatician
Somerset, NJ ยท Hybrid
... Biotech is seeking a Principal Bioinformatician as part of the Early Drug Development team based in ... Partner closely with Translational scientists, Clinical Development, Research and CMC teams, CROs ...
Principal Bioinformatician
Somerset, NJ ยท Hybrid
... Biotech is seeking a Principal Bioinformatician as part of the Early Drug Development team based in ... Partner closely with Translational scientists, Clinical Development, Research and CMC teams, CROs ...
Cmc In Biotech information
What is a CMC in biotech position?
What is the difference between Cmc In Biotech vs Formulation Scientist?
| Aspect | Cmc In Biotech | Formulation Scientist |
|---|---|---|
| Required Credentials | Bachelor's or Master's in Life Sciences, Good Manufacturing Practice (GMP) knowledge | Bachelor's or Master's in Pharmacy, Chemistry, or related field; GMP experience |
| Work Environment | Laboratories, manufacturing facilities, regulatory settings | Laboratories, R&D departments, manufacturing units |
| Employer & Industry Usage | Biotech companies, pharmaceutical firms, contract manufacturing organizations | Pharmaceutical companies, biotech firms, contract labs |
While both roles operate within the biotech and pharmaceutical industries, Cmc In Biotech focuses on Chemistry, Manufacturing, and Controls documentation and regulatory compliance, whereas Formulation Scientists primarily develop and optimize drug formulations. Cmc In Biotech professionals ensure regulatory submissions are complete, while Formulation Scientists work on creating effective drug delivery systems. Both roles often collaborate but serve distinct functions within the product development pipeline.
What is a CMC in biotech?
What is the CMC department in biotech?
- Director Preclinical
- Executive Director Of Regulatory Affairs
- Associate Director Regulatory Affairs Cmc
- Cmc Regulatory Affairs
- Associate Director Biopharma Pharmaceutical
- Director Peptide Synthesis
- Remote Legislative Affairs Director
- Vice President Of Regulatory Affairs
- Vice President Cmc Regulatory Affairs
- Director Stealth Biotech
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 9 days ago
Job description
Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTIยฎ (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.
Legend Biotech is seeking a Manager, Regulatory Project Management as part of the Regulatory team based in Somerset, NJ.
Role Overview
This role will be reporting to the Director of Project Management Regulatory. We are seeking a motivated, detail-oriented Project Manager to support the planning and execution of Cell & Gene Therapy development programs. Working closely with cross-functional teams, this individual will coordinate project activities, monitor timelines, facilitate effective communication, and provide administrative support to ensure projects are executed efficiently and meet key development milestones. This opportunity is well suited to an individual with early-career project management experience in the biotechnology or pharmaceutical industry who is eager to grow in a fast-paced, collaborative environment. The successful candidate will play a key role in project coordination, documentation, meeting management, and operational support throughout the product development lifecycle.
Key Responsibilities
- Coordinate day-to-day project activities across cross-functional teams, including Research, CMC, Quality, Regulatory Affairs, Clinical Operations, and external partners.
- Develop and maintain project timelines, action-item trackers, meeting agendas, and other key project documentation.
- Schedule and facilitate project team meetings, prepare meeting minutes, and follow up on action items to support timely completion.
- Monitor project progress and promptly escalate potential risks, delays, and resource constraints to project leadership.
- Support the preparation and coordination of activities related to Investigational New Drug (IND) submissions and other regulatory filings.
- Track project budgets, purchase orders, invoices, and resource utilization in collaboration with Finance and functional leads.
- Assist with preparation of project dashboards, presentations, reports, and materials for leadership reviews, governance meetings, and investor or partner updates.
- Assist with onboarding new project team members by coordinating access to systems, project documentation, and team resources.
- Provide general administrative support to the cross function as needed.
- Support vendor onboarding, contract routing, purchase requisitions, and invoice processing in partnership with Procurement and Finance.
- Facilitate clear, effective communication among internal stakeholders and external collaborators, including contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs).
- Ensure project documentation is accurate, well organized, and maintained in accordance with company procedures.
- Contribute to the continuous improvement of project management processes, templates, and best practices.
Requirements
- Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or a related scientific field. Master's degree preferred.
- 1-3 years of experience in project coordination, project management, program support, or administrative project support within the biotechnology, pharmaceutical, or life sciences industry.
- Familiarity with Cell & Gene Therapy, biologics, or related therapeutic development is preferred.
- Basic understanding of the drug development process, including preclinical development, CMC activities, and IND submissions.
- Experience working in cross-functional teams within a regulated environment is preferred.
- Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
- Excellent written, verbal, and interpersonal communication skills.
- Proficiency with Microsoft Office (Excel, PowerPoint, Word) and project management tools such as Microsoft Project, Smartsheet, or similar platforms.
- PMP or CAPM certification is a plus but not required.
#Li-JR1
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The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.
Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.
Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
Pay Range (Base Pay):
$110,706-$145,303 USD
Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.
Work Authorization & Employment Eligibility
Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.
For information related to our privacy notice, please review: Legend Biotech Privacy Notice.