Job Information
Vigene Biosciences Manager, GMP Manufacturing in Rockville, Maryland
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.