TITLE: Team Lead, Upstream GMP Manufacturing
DEPARTMENT: GMP Manufacturing
LOCATION: Rockville, Maryland
Vigene Biosciences is a fast growing, dynamic gene therapy contract development and manufacturing company and a leader in viral vector based gene delivery for both life science research, gene therapy and cell therapy purposes. Our team is passionate about collaborating with our clients to advance medical science.
The Team Lead: Upstream GMP Manufacturing will lead a team and work directly with a range of bioreactor and recovery technologies such as single-use systems (adherent and suspension), fltration technologies (TFF and depth), and centrifugation following aseptic techniques and procedures in a cGMP environment.
- 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.
- Ensures 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.
- Acts as manufacturing subject matter expert for assessments for change controls, validation protocols, and document changes.
- Works 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.
Required Skills & Abilities:
- Experience with Upstream operations in a biologics production facility – single-use bioreactors, aseptic technique, product recovery (centrifugation, clarification, etc.)
- Ability to operate manual, semi-automated, and automated equipment in support of routine production under supervision.
- Teaming and collaboration
- Great attention to detail
- Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary.
- Bachelor's degree and at least four (4) years of biomanufacturing experience: on-the-floor leadership or 'subject matter expertise' in cGMP manufacturing
- High School Diploma/Associate’s degree five (5) years of biomanufacturing experience: on-the-floor leadership or 'subject matter expertise' in cGMP manufacturing
Desired but not required qualifications:
- Previous work in viral or vaccine production highly desired
- Training in Lean Six Sigma
- Experience in biologics fill/finish
- Previous experience in contract manufacturing
- Previous experience in a development role
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
- biomanufacturing: 4 years (Preferred)
- Upstream operations in a biologics production facility: 1 year (Preferred)