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Program Biotech Jobs in Virginia (NOW HIRING)

You'll identify, qualify, develop, and close opportunities across pharma and biotech - connecting ... Our 'Bank Your Bank Holiday' program allows you to exchange public holidays for dates that hold ...

Lead and manage teams to deliver a greenfield Utilities program of $500MM USD or more in capital ... Biotech, biologics, or bioconjugate manufacturing experience * Capital Project Management ...

... 6S programs. Must be willing to gown and work in a "clean room" environment. Administrative tasks - attending shift exchange, meetings, sending/receiving emails, participating in projects. • ...

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Program Biotech information

What are the key skills and qualifications needed to thrive as a Program Biotech professional, and why are they important?

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 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 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 are popular job titles related to Program Biotech jobs in Virginia? For Program Biotech jobs in Virginia, the most frequently searched job titles are:
What cities in Virginia are hiring for Program Biotech jobs? Cities in Virginia with the most Program Biotech job openings:
Quality Engineer/Controlled Substance Program Lead

Quality Engineer/Controlled Substance Program Lead

Thermo Fisher Scientific

Middletown, VA • On-site

$63.30K - $81.80K/yr

Full-time

Posted 7 days ago


Thermo Fisher Scientific rating

7.7

Company rating: 7.7 out of 10

Based on 384 frontline employees who took The Breakroom Quiz

185th of 511 rated manufacturers


Job description

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
As a Quality Engineer III and Controlled Substance Program Lead, you'll help ensure quality excellence and regulatory compliance to DEA across manufacturing operations. You'll help ensure our products meet the highest Quality and regulatory Compliance standards while supporting our mission to enable customers to make the world healthier, cleaner and safer. This role combines technical expertise with quality oversight to maintain robust quality management systems, lead investigations, drive continuous improvement, and ensure GMP/ISO and DEA compliance.
The role is responsible for overseeing the Controlled Substance Program to ensure compliance with applicable regulatory requirements and internal quality standards. In addition, the position collaborates cross-functionally with multiple teams to investigate and resolve quality issues, conduct risk assessments, manage CAPA activities, support internal and external audits, and drive continuous quality improvement initiatives. The role requires strong analytical, problem-solving, and communication skills to effectively interface with internal stakeholders, customers, and regulatory agencies while helping establish, maintain, and enhance quality systems and compliance practices.
Location: Middletown, VA
Relocation assistance is NOT provided.
REQUIREMENTS:
Education & Experience
  • Advanced degree with 3+ years of experience in Quality Assurance within a regulated industry
    OR
  • Bachelor's degree with 5+ years of experience in Quality Assurance within a regulated industry (pharmaceutical, medical device, biotech, or related field)
  • Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field

Preferred Certifications
  • ASQ Certifications such as: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)

Technical & Regulatory Expertise
Strong knowledge of:
  • cGMP requirements
  • ISO 13485 / ISO 9001 standards
  • DEA regulations
  • FDA, EMA, and other applicable regulatory requirements

Experience with quality systems and processes including:
  • CAPA and deviation management
  • Change control
  • Risk management and FMEA
  • Document control
  • Internal and external auditing
  • Validation and qualification protocols

Skills & Competencies
  • Advanced problem-solving and root cause analysis skills
  • Strong project management capabilities
  • Excellent verbal and written communication skills
  • Proficiency with quality management systems/software and Microsoft Office
  • Knowledge of statistical analysis and quality tools
  • Ability to work independently and collaboratively in cross-functional environments
  • Strong attention to detail while maintaining a strategic, big-picture perspective
  • Excellent interpersonal and stakeholder management skills

Additional Requirements
  • Ability to travel up to 25% as needed
  • Must be legally authorized to work in the United States without sponsorship.
  • Must be able to pass a comprehensive background check, which includes a drug screening.

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