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Program Biotech Jobs in Elizabeth, NJ (NOW HIRING)

Legend Biotech US

Manager, Regulatory CMC

Somerset, NJ · Hybrid

Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in ... Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to ...

Legend Biotech US

Director, Regulatory Affairs

Somerset, NJ · On-site

$158K - $209K/yr

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... programs. * Lead the team efforts required for the submission of INDs, CTAs, and BLAs as well as ...

Legend Biotech US

Metrology Tech I

Raritan, NJ · On-site

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Provides technical expertise in support of an effective calibration program that supports daily ...

Legend Biotech US

Operations Supervisor

Raritan, NJ · On-site

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... projects/programs forward in a matrixed environment. * Clear and succinct verbal and written ...

Legend Biotech US

Investigations Supervisor

Raritan, NJ · On-site

Ability to utilize various standard programs for data entry and word processing. * Language(s): English #Li-BZ1 #Li-Onsite The base pay range below is what Legend Biotech USA Inc. reasonably expects ...

Legend Biotech US

Sr. Manager Engineering

Raritan, NJ · On-site

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Drive effectiveness of corrective and preventive action (CAPA) programs by ensuring sustainable ...

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Showing results 41-60

All JobsProgram Biotech JobsProgram Biotech Jobs in Elizabeth, NJ

Program Biotech information

See Elizabeth, NJ salary details

$25.2K

$52.7K

$91.1K

How much do program biotech jobs pay per year?

As of Sep 11, 2026, the average yearly pay for program biotech in Elizabeth, NJ is $52,696.00, according to ZipRecruiter salary data. Most workers in this role earn between $40,300.00 and $59,900.00 per year, depending on experience, location, and employer.

What is a program biotech?

A Program Biotech is a professional who manages and coordinates biotechnology projects or programs within an organization. They oversee research and development activities, ensure compliance with regulations, manage budgets, and facilitate collaboration between scientists, engineers, and other stakeholders. Their role is crucial in bringing biotech innovations from concept to market by ensuring projects stay on schedule and meet organizational goals.

What are the key skills and qualifications needed to thrive as a program biotech professional?

To excel as a Program Biotech professional, you need a solid background in life sciences, project management, and regulatory knowledge, often supported by an advanced degree in biotechnology or a related field. Familiarity with laboratory information management systems (LIMS), project management software, and compliance frameworks like GLP or GMP is common. Strong leadership, problem-solving abilities, and effective communication are crucial soft skills for coordinating multidisciplinary teams. These skills and qualifications are essential to drive innovation, ensure regulatory compliance, and achieve successful outcomes in complex biotech projects.

What are some common challenges faced by program biotech professionals when managing cross-functional teams?

Program Biotech professionals often coordinate projects that involve diverse teams, including research scientists, regulatory specialists, and business development staff. One key challenge is ensuring clear communication and alignment among team members with varying backgrounds and priorities. Additionally, balancing project timelines with regulatory requirements and scientific uncertainties can require strong problem-solving skills. Being proactive in facilitating collaboration and adapting to shifting project goals are essential for success in this role.

What is the difference between Program Biotech vs Laboratory Technician?

AspectProgram BiotechLaboratory Technician
Required CredentialsBiotech degree or certification, specialized trainingAssociate degree or certification in laboratory sciences
Work EnvironmentResearch labs, biotech companies, pharmaceutical firmsClinical, research, or industrial labs
Employer & Industry UsageBiotech firms, research institutions, pharma companiesHospitals, research labs, manufacturing plants
Common Search & ComparisonYesNo

Program Biotech professionals focus on research, development, and overseeing biotech projects, often requiring advanced degrees and specialized training. Laboratory Technicians perform routine lab tests and support research or manufacturing processes, typically with an associate degree. While both roles work in lab environments within the biotech and healthcare industries, Program Biotech roles are more research-oriented, whereas Laboratory Technicians handle day-to-day testing and sample analysis.

What job categories do people searching Program Biotech jobs in Elizabeth, NJ look for?

The top searched job categories for Program Biotech jobs in Elizabeth, NJ are:

What cities near Elizabeth, NJ are hiring for Program Biotech jobs?

Cities near Elizabeth, NJ with the most Program Biotech job openings:

Program Biotech jobs near you

Manager, Regulatory CMC

Somerset, NJ • Hybrid

Legend Biotech US
See more jobs at Legend Biotech USexternal

Full-time

Posted 20 days ago

Job description

Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. 

Role Overview

This position will support the development and execution of global CMC regulatory strategies for pipeline programs, with a strong focus on regulatory dossier authoring and cross-functional collaboration to advance product development milestones.

Key Responsibilities

  • Support the development and execution of global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T and lentiviral vector products.
  • Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to plan, prepare, review, and coordinate CMC components of global regulatory submissions, including INDs, CTAs, BLAs, MAAs, amendments, supplements, and responses to Health Authority requests.
  • Author, review, and maintain high-quality CMC regulatory documentation to support global development, registration, and commercialization activities, ensuring compliance with applicable regulatory requirements and company standards.
  • Collaborate with cross-functional technical teams, including Process Development, Manufacturing,
  • Analytical Development, and Quality, to understand complex CMC information and effectively translate it into clear, scientifically sound regulatory submissions.
  • Evaluate and interpret technical documentation, including development reports, validation protocols and reports, comparability assessments, and manufacturing change packages, to support regulatory impact assessments, submission strategies, and regulatory decision-making.

Requirements

  • Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Biochemistry, Chemistry, Engineering, or related discipline required. Advanced degree (MS, PhD, PharmD) preferred.
  • 5+ years of biotechnology or pharmaceutical industry experience with strong technical background.
  • Minimum of 1-2 years of Regulatory CMC experience supporting biologics, cell and gene therapy products, or extensive experience authoring and managing CMC sections of regulatory dossiers and submissions.
  • Experience working with process development, analytical development, or manufacturing teams.
  • Experience supporting cell and gene therapies highly preferred.
  • Familiarity with global regulatory requirements, including FDA, EMA, and ICH guidelines.
  • Strong scientific understanding and technical background on biologics or cell and gene therapy products.
  • Excellent technical writing and document preparation skills with demonstrated experience authoring regulatory submission content.
  • Ability to critically review and interpret scientific and technical data and translate complex information into clear regulatory documentation.
  • Strong project management and organizational skills.
  • Ability to manage multiple programs and competing priorities in a fast-paced environment.
  • Strong communication and collaboration skills with cross-functional stakeholders.

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