Manufacturing Manager
- East Coast
- Contract
- Life Sciences
This vacancy has now expired
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.
The Role:
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.
Job Function:
- 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.
To view Quanta's privacy policy, please visit our website
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
Save as job alert
Similar Jobs
Salary
Competitive
Location
Milton Keynes
Salary
Competitive
Sector
Life Sciences
Job type
Contract
Location
South East
Description
IT Project Manager – Pharmaceuticals – Contract – Milton Keynes Our global pharmaceutical client based in Milton Keynes is now looking for an IT Project Manager to join their team on an
Reference
33909
Expiry Date
01/01/0001
Author
James SmithsonAuthor
James SmithsonSalary
Competitive
Location
Reading
Salary
Competitive
Sector
CAPEX Projects
Job type
Permanent
Location
Cork
Description
Tech Transfer Project Manager - Pharma - Cork - 12-Month Contract Would you like the opportunity to work alongside a global healthcare product manufacturer who are the leaders in the production
Reference
33952
Expiry Date
01/01/0001
Author
Abigail StierAuthor
Abigail StierSalary
Competitive
Location
West Zealand
Salary
Competitive
Sector
CAPEX Projects
Job type
Contract
Location
Denmark
Description
Cost Controller / Cost Engineer - East Zealand, Denmark - 12-Months Are you a Cost Controller looking for your next contract opportunity in Denmark? Quanta has the role for you! Our client
Reference
33971
Expiry Date
01/01/0001
Author
Alex StanfordAuthor
Alex StanfordInsights
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.
Janis
I manage this role.