BS in Immunology, Cell or Molecular Biology, Chemistry, Biochemistry, Biology, or Bioengineering with 2 years of relevant experience, or an associate degree with over 4 years of experience preferred.
Ability to promote a culture of continuous improvement and operational excellence.
High technical proficiency, with knowledge of COBE cell processor and cell encapsulation as a plus.
Excellent verbal and written communication skills to interface with various stakeholders.
Knowledge of Microsoft Office and EMS systems is required.
Flexibility to work different shifts and to handle aseptic gowning in controlled environments.
Prior experience in clinical/commercial biopharmaceutical manufacturing and regulatory inspections is desired.
Responsibilities
Provide technical support to Manufacturing Technicians in Clean Rooms or Pilot Lab.
Act as a back-up to team members when necessary.
Ensure availability and organization of supplies and materials for projects.
Follow up on technical manufacturing issues and initiate escalation as needed.
Assist in improving reporting of technical issues and work orders for Manufacturing Management.
Perform pilot plant experiments to support New Product Development or Process Innovation projects.
Collaborate with facilities to ensure timely resolution and closure of work orders.
Oversee and maintain equipment calibration, validation, and qualification requirements.
Benefits
Collaborative work environment with opportunities for continuous improvement.
Exposure to innovative New Product Development and Process Innovation projects.
Engagement in meaningful work that directly impacts biopharmaceutical manufacturing.
Support from experienced team members and opportunities for professional development.
Chance to work with advanced technologies such as COBE cell processors.
Full Job Description
Key Responsibilities:
Provide technical support to Manufacturing Technicians while processing in Clean Rooms or Pilot Lab.
Process regularly and be a back-up in case team members are not available as needed.
Ensure supplies and materials needed for projects are available and organized.
Follow up regarding manufacturing technical situations/issues throughout the day and initiate escalation process as needed.
Assist Manufacturing Management in maintaining and improving the reporting of technical issues, work orders, equipment tag outs, equipment swaps etc.
Perform pilot plant experiments to support New Product Development or Process Innovation projects as needed.
Collaborate with facilities to ensure work orders are resolved and closed in a timely manner.
Responsible for equipment tracker Excel file in MS Teams.
Collaborate with SME to ensure manufacturing internal trackers are easily accessible, accurate and up to date.
Responsible to oversee and ensure all equipment is calibrated, validated, and qualified as required.
Ensure equipment is returned "as found" while maintaining its calibration/qualification/validation.
SME in writing, revising, and reviewing SOP's Instructions and Forms to better improve process.
SME to Initiate, assess impact and produce root cause analysis related to Deviations. Initiate and oversee CAPA and Change Controls as needed, collaborate with other team members and QA to perform appropriate investigations and analysis.
Participate in investigations regarding equipment issues, providing an SME assessment to the main investigator.
Be the back-up SME for manufacturing data for trending and key performing attributes.
Ensure data is collected and entered in the appropriate spreadsheet at the end of each production run with minimum delay.
Be a back-up in the absence of a supervisor as needed.
Knowledge, Skills, and Experience:
BS in Immunology, Cell or Molecular Biology, Chemistry, Biochemistry, Biology or Bioengineering with 2 years of relevant industry experience or an associate degree with over 4 years of relevant industry experience preferred but not required.
Ability to foster culture of continuous improvement and operation excellence.
High technical proficiency. Knowledge or COBE cell processor and cell encapsulation is a plus.
Excellent technical communication skills, both verbal and written, and the ability to constructively interface effectively with all departments, all levels of organization and external vendors.
Knowledge of Microsoft office and EMS system.
Flexibility to work different shifts.
Ability to aseptically gown in an ISO 8/ISO 7 clean room environment.
Prior experience in clinical/commercial biopharmaceutical manufacturing and regulatory agencies inspections desired.
Proficient in cGMP regulations as well as FDA.
Demonstrated ability to manage multiple projects independently.
Flexibility to handle and manage both long-term development projects and short-term troubleshooting needs.
Critical analytical thinking and problem-solving capabilities.
Strong computer and communication skills, both written and oral.
