Careers | Vigene Biosciences

Careers

Careers at Vigene Biosciences, A Charles River Company

Headquartered in Rockville, Maryland, Vigene Biosciences, A Charles River Company, 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, A Charles River Company, 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

Director, Plasmid Manufacturing

Job Title
Director, Plasmid Manufacturing
Location
Rockville,  MD 20850
Other Location
Description

JOB TITLE: Director, Plasmid Manufacturing

DEPARTMENT: Plasmid Production

REPORTS TO: Head of Vigene Operations

LOCATION: Rockville, MD (5-Research)

General Description

Vigene Biosciences has been a leader at the forefront of cell and gene therapy, Adeno-Associated virus or AAV vector production, adenovirus vector production, lentivirus vector production, retrovirus vector production, plasmid production, viral vector QC and analytical services, plasmid QC and analytical services, providing services and products to support this rapidly growing and increasingly important field.

The Director, Plasmid Production, leads the Plasmid Manufacturing department and provides overall leadership for projects and ensuring delivery against work orders, budgets, as well as business plan goals. This position works cross-functionally with several departments/personnel to ensure the close coordination and planning necessary for GMP plasmid production. Maintain compliance of all systems in the plasmid manufacturing facility.

Duties and Responsibilities

  • Provide oversight and supervision of staff and resources performing plasmid production (research grade, GMP-Ready, and GMP Grade Plasmid DNA) such as process and method development and validation, stability, QC, etc. 
  • Manage the plasmid in-process assays 
  • Manage and execute the work activities of group and associates, resource planning and allocation, client communication, technical document generation and review, mentoring technical staff, troubleshooting method and product-related issues, draft Batch Records, and conduct Good Manufacture Processing compliant with global regulatory requirements
  • Ensure the compliance of work performed as well as working with manager to meet the financial goals of the organization
  • Work collaboratively with Project Directors/Leads from all functional areas (i.e., Engineering, Quality, Process Development, Validation, Metrology, Materials Management, Regulatory Affairs) 
  • Lead the development and implementation of all operational procedures and policies related to Vigene Bioscience Plasmid Manufacturing Operations 
  • Ensure that production facilities are maintained at a high standard of readiness (validated, calibrated, qualified, continually operational) 
  • Ensure all staff maintain an appropriate level of training 
  • Identify and mitigate risks in manufacturing operations that could negatively impact projects and delivery of treatment to patients 
  • Establish and effectively manage department annual operating budgets for all of the site’s Plasmid Manufacturing Operations 
  • Establish robust scheduling systems to maximize the use of facility and staff to optimize the capacity and throughput of operations continually
  • Other responsibilities as needed

Qualifications for the Job

  • Master's degree and at least 4-6 years of experience that provides the knowledge, skills, and abilities to perform the job; Ph.D. is preferred
  • Experience with Process Validation and Commercial Biologic’s manufacture 
  • Experience in Quality Systems with experience in leading teams in successful through development and launch in various product line in multiple regions 
  • Excellent understanding of cGMP principles, including validation and the regulatory path for Biologic drug approval
  • Experience in risk management and preferably experience in lean manufacturing experience 
  • Technical/Scientific expertise in biologics and aseptic manufacturing 
  • Strong Communicational Influence 
  • Demonstrated Client Interaction and Project Management experience 
  • Proven ability in managing and coaching experienced research scientists and associated projects 
  • Strong Molecular Biology knowledge and background 
  • Relevant experience with research grade plasmid DNA production and GMP Plasmid DNA production and microbial fermentation and purification 
  • Use strong communication and teamwork skills to build strong relationships with stakeholders 
  • Demonstrate outstanding technical acumen, operational understanding, and GMP compliance in building and running the Manufacturing Operations Department 
  • Provide oversight for the maintenance/retrofit of existing plasmid manufacturing facility 
  • Serve on appropriate Project Teams as the Senior Manufacturing representative for plasmids
  • Provide critical leadership for interactions with various agencies (e.g., regulatory agency meetings such as FDA, EMA, etc.) 
  • Champion the implementation of new technologies and systems 
  • Strong analytical, strategic thinking and troubleshooting skills 
  • Provide leadership in the development of strategic Plasmid manufacturing plans

Key Competencies

  • Demonstrates integrity and respect
  • Delivers results
  • Demonstrates business acumen
  • Fosters collaboration and teamwork
  • Champions change

Working Conditions

  • Must be able to lift up to 40lbs.
  • Standing, sitting, waking, pushing, pulling, reaching, and bending

Vigene Biosciences, Inc. is an equal employment opportunity employer and does not discriminate against any applicant based on 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.

 

Required Skills

Masters degree and 4-6 years of experience that provides the knowledge, skills, and abilities to perform the job; Ph.D. is preferred; 

Experience with Process Validation and Commercial Biologic’s manufacture 

Experience in Quality Systems with experience in leading teams in successful through development and launch in various product line in multiple regions 

Excellent understanding of cGMP principles, including validation and the regulatory path for Biologic drug approval. 

Experience in risk management and preferably experience in lean manufacturing experience 

Technical/Scientific expertise in biologics and aseptic manufacturing 

Strong Communicational Influence
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