Our client is a leading and rapidly expanding Biologics company looking for a Manufacturing Manager to support them meet their customers’ needs and drive manufacturing process and teams.
Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices.
- Oversees and monitors overall performance of aseptic technique ensuring compliance with standards
- Trains, coaches, mentors front line management and manages performance of others.
- Understands, determines and manages maintenance requirements (preventative and calibration) of equipment and works with vendor to resolve issues
- Drives sourcing and purchasing of standard, new and complex equipment
- Reviews and approves solution and material preparation results and resolves issues
- Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy
- Possesses basic and fundamental engineering and mechanical knowledge and isable to apply in the manufacturing area demonstrating unit operational and end-to-end understanding
- Has participated in facility start-ups and may lead a subteam that requires leading,planning, coordinate, delegate and manage across site specific programs
- Reviews and approves protocols and other technical transfer documents
- Identifies and drives application of GMP concepts and is able to recommend and
- identify improvements as the process develops across the site during phases of technical transfer
- Executes in-house and offsite validation activities
- Identifies validation gaps and needs across site specific programs
- Approves CS forms
- Approves change controls for new material implementation
- Possess awareness for all support systems (e.g. LIMS)
- Acts a lead, member, Champion or Sponsor that helps to design the new system or of a systems improvement team
- Identifies process and method gaps and opportunities and implements improvements across site
- Collects, records, reviews, performs analysis, interprets, identifies trends of scientific and process data per good document practices
- Communicates with internal and external stakeholders scientific and process data and recommends path for forward processing
- Follows compliance and regulatory requirements and current Good Manufacturing
- Practices (cGMPs) and understands ‘why’ behind the regulations.
- Follows and executes Standard Operating Procedures (SOPs)
- Reviews and approves SOPs
- Improves the efficiency and right-first-time (RFT) of BR execution
- Accountable for ensuring front line management ensure associates are trained on SOPs, equipment, all unit operations and non-manufacturing SOPs and systems
- Identifies, participates, suggests solutions and leads complex technical problem solving
- First line decision maker for technical problems
- Accountable for schedule preparation, forecasting, adjustments and performance of work assignments for team to ensure adequate staffing across site specific programs and site
- Regularly interacts with groups that support manufacturing
- Coordinates, deals with problems and is the first line manufacturing decision maker with groups that support manufacturing in a cross functional manner
- Has basic financial knowledge and acumen
- Manages the manufacturing process, projects and people
- Demonstrated Lean / Six Sigma knowledge desired
Qualifications and Skills:
- HS Diploma or equivalent required and
- 5+ years relevant technical experience and min 2 years Managing people
- BS/BA in Science related field preferred; or combination of relevant Experience & Education
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
Piping Black Utilities Lead - Global Biopharmaceutical Client - USA Our client is making a significant capital investment for a new biologics facility in the USA and requires a Piping Black
Junior Engineering Manager - Global Biopharmaceutical Client - USA Our client is making a significant capital investment for a new biologics facility in the USA and requires a Junior Engineering
Senior Process Engineer (CIP & Support Equipment) - Global Biopharmaceutical Client - USA Our client is making a significant capital investment for a new biologics facility in the USA and requires
Send us your CV
Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.