Careers | Vigene Biosciences

Careers

Careers at Vigene

Headquartered in Rockville, Maryland, Vigene Biosciences is a rapidly growing company that strives to be a leading manufacturer of viral vectors. We are proud to support researchers at any stage of development: from basic research, to animal studies, to clinical trials and commercialization. Our diverse customer base includes scientists all across the world from academia, government organizations, research institutes, biotechnology companies, and pharmaceutical companies.

We are passionate about our mission to help support scientists advance their biomedical research and ultimately to make gene therapy affordable and available to those in need. As we continue to grow, we are always looking for talented people to join our team who share our passion. We value our employees as important contributors to our mission, so we provide opportunities for career growth and encourage employees to develop new skills so they can grow with our company.

Equal Opportunity Employer

Vigene Biosciences is an EEO/AA employer. Vigene Biosciences, Inc. is an equal employment opportunity employer and does not discriminate against any applicant on the basis of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law. If you need reasonable accommodation for any part of the employment process, please contact us by email at jobs@vigenebio.com and let us know your request and contact information. Please note that only inquiries concerning a request for reasonable accommodation will be acknowledged from this email address. Requests for accommodation will be considered on a case by case basis.

Benefits

  • Healthcare benefits (Medical and Dental/Vision Insurance)
  • 100% Company Paid Life Insurance
  • 100% Company Paid Accident Insurance
  • Short and Long Term Disability Insurance
  • Paid Vacation, Floating Holidays and Sick Leave
  • 401(k) Plan with Safe Harbor Match
  • Employee Assistance Program
  • Dependent Care and Commuter/Transit FSA
  • Adoption Assistance
  • Education Assistance
  • Competitive Salary and Performance Bonus
  • Career development opportunities
  • Work-Life Balance
  • Fun, collaborative environment

Manager, GMP Manufacturing

Job Title
Manager, GMP Manufacturing
Location
Rockville,  MD 20850
Other Location
Description

Department: GMP Manufacturing

Reports to: Chief Operating Officer

Location: Rockville, MD

Company Overview

Vigene Biosciences, Inc. is an award winning CDMO that provides viral vector-based gene delivery services and products for research and clinical applications. We are proud to support scientists at any stage of research: from basic research, to animal studies, to clinical trials and commercialization. Our diverse customer base includes thousands of scientists all across the world from academia, government organizations, research institutes, biotechnology companies, and pharmaceutical companies.

Job Summary:

Leads the manufacturing team through production campaigns, owning the production suites, and being accountable for schedule adherence. This individual is passionate about: building a continuous learning environment within manufacturing and with department colleagues in development and technical transfer and support, sharing of best practices and learning opportunities, and building robust readiness and execution processes to drive sustainable right-first-time performance

Essential Duties & Responsibilities:

  • Provide a service-oriented and results mindset to delight both internal and external customers
  • Create a new department from the ground-up to support a high velocity organization
  • Ensure safety of manufacturing area and work practices 
  • Provide leadership, guidance, and direction to staff to create a quality-centric organization 
  • Drive continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
  • Ensure the successful technical transfer of projects from the Tech transfer group to the GMP production group 
  • Establish and maintain key performance indicators in alignment with department and product supply goals, maintain and report applicable area or organizational metrics
  • Organize and lead ad hoc cross functional teams to manage investigations and implementation of changes 
  • Act as manufacturing subject matter expert for assessments for change controls, validation protocols, and document changes
  • Work closely with the production staff to troubleshoot process and equipment problems
  • May create, revise, and edit SOP, batch records, and specs as needed 
  • Actively participates in all recruiting efforts to secure, onboard, and develop new staff members
  • Other responsibilities as needed

Non-Essential Duties & Responsibilities:

  • n/a

Supervisory Responsibilities:

  • GMP Employees

Knowledge & Other Qualifications:

  • B.S. and 11+ years of related work experience or M.S. and 8+ years of biologics experience. Minimum of 5 years in management / leadership positions.
  • High School Diploma/Associate’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 15+ years of biopharmaceutical manufacturing (GLP or GMP)
  • Minimum of 3 years leading cGMP operations teams in fast paced production environment

Other Characteristics:

  • Previous work in viral or vaccine production highly desired 
  • Training in Lean Six Sigma preferred
  • Experience in biologics fill/finish preferred
  • Previous experience in contract manufacturing preferred 
  • Previous experience in a development role preferred
  • Authorized to legally work in the United States without visa sponsorship

Physical Requirements/Work Environment/Travel Requirements:

  • Operations are 24 hours per day, 7 days per week, and shift work will be required
  • Must be able to lift up to 20 lbs
  • Standing, sitting, pushing, pulling, walking

Vigene Biosciences, Inc. is an equal employment opportunity employer and does not discriminate against any applicant on the basis of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.

Job Type: Full-time

COVID-19 considerations:
We have established multiple policies to protect our employees' health & safety while allowing essential operations to continue following social-distancing & PPE guidelines. Non-essential departments are working remotely and/or working alternative hours.

Required Skills

GMP
Openings
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