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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.

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