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 firstname.lastname@example.org 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.
- 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, Downstream Process Development (PD)
- Job Title
- Director, Downstream Process Development (PD)
- Rockville, MD 20850
- Other Location
Title: Director of Downstream Process Development (PD)
Department: Process Development
Reports to: CEO
Location: Rockville, MD
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.
Leads process development for Vigene Biosciences, Inc. Interacts extensively with the Upstream PD, GMP Manufacturing, Quality Assurance, and Quality Control teams, as well as clients to ensure project success
Essential Duties & Responsibilities
- Oversee Downstream PD and trains Downstream PD staff
- Work with Quality Assurance and Quality Control teams to ensure full compliance with cGMP regulatory requirements
- Work with Upstream PD while coordinating multiple client projects simultaneously
- Author, review, and revise Batch Production Records in a timely fashion
- Motivate, retain, and develop existing group members and recruit new staff to build a strong Downstream PD team
- Contribute to continual improvement of all manufacturing documentation to ensure they are current, accurate, and clear
- Communicate operational status regularly to the CEO, as required, at the appropriate level of detail
Non-Essential Duties & Responsibilities
- Oversee Downstream PD Associates and Scientists
Knowledge & Other Qualifications
- Ph.D. or M.S. in life sciences, chemical engineering, biochemical engineering, biochemistry, or closely related field is required
- At least 10 years of experience in industrial downstream process development and GMP manufacturing, especially in gene and cell therapy
- Strong virus and protein purification experience is required (cell and gene therapy, virology, or biologics preferred)
- Understanding of upstream bioreactor production and downstream purification operations such as centrifugation, ultra-filtration, and chromatography from pilot to GMP scale is required
- Strong understanding of GxPs, process characterization/validation, and technology transfer is required
- Experience working in a regulated environment (GMP and GLP) is a plus
- Ability to work independently to lead a cross-functional team to support corporate goals
- Ability to adapt to frequent change and thrive in a dynamic and entrepreneurial early-stage environment
- Strong communication and organization skills, good working knowledge of MS office, data plotting and graphing software and DoE
- Authorized to legally work in the United States without visa sponsorship
Physical Requirements/Work Environment/Travel Requirements
- Must be able to lift up to 25 lbs.
- Standing, sitting, pushing, pulling
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
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