Manufacturing Specialist I

Iovance Biotherapeutics•Philadelphia, PA

2d•Onsite

About The Position

Iovance Biotherapeutics is an immune-oncology company developing and commercializing tumor-infiltrating lymphocyte (TIL) therapies. The Manufacturing Specialist I supports manufacturing operations through documentation, investigation and resolution of deviations, change control management, technology transfer, and manufacturing-floor troubleshooting. The role works on routine and moderately complex assignments, independently or as part of a team, and contributes to projects and process improvements while helping ensure work is completed on time and complies with GMP, GDP, SOPs, and regulatory requirements. The position has regular first-shift workweek hours, Monday through Friday, and may require up to 10% travel based on business needs. Work takes place in both an office and a manufacturing cleanroom. The employee must follow company policies and safety procedures and be able to work in the cleanroom environment, including wearing required attire and PPE.

Requirements

Bachelor’s degree in biology, biochemistry, bioengineering, or a related technical field, or equivalent industry experience; an equivalent combination of education and experience may be accepted.
At least 2 years of experience in biopharmaceutical GMP manufacturing operations.
Strong technical knowledge of aseptic processing in cleanroom environments.
Familiarity with 21 CFR Part 11, GxP best practices, and FDA regulations.
Familiarity with data and sample management systems, including LIMS/MES.
Proficiency in Microsoft Excel, Word, and Outlook; ability to read, write, and understand English.
Strong written and verbal communication, presentation, organizational, computer, problem-solving, and attention-to-detail skills.
Ability to work independently with minimal supervision and successfully in a fast-paced, team-oriented environment.
Ability to build credible working relationships, support and influence diverse manufacturing teams, and demonstrate leadership in a complex manufacturing environment.
Proactive, results-oriented, self-starting approach and ability to adapt plans and priorities amid ambiguity and change.
Ability to work in an office and manufacturing cleanroom environment and comply with applicable safety procedures.
Ability to wear cleanroom attire and PPE; stand or walk for 90% of the work time and sit for 10%; climb ladders or steps; crouch, bend, twist, reach, and perform repetitive motions; and lift and carry objects weighing up to 45 pounds.
Ability to meet the position’s mental demands, including clear and conceptual thinking, sound judgment, troubleshooting, problem-solving, analysis, discretion, managing work-related stress and multiple priorities, and meeting deadlines.

Responsibilities

Support documentation, including drafting and approving SOPs, batch records, deviations, and CAPAs, and revise documents to reflect current procedures.
Lead investigations of minor, major, and critical nonconformances and deviations, including gathering information through structured root-cause analysis.
Draft and revise deviation reports and manage manufacturing-area and equipment change controls.
Participate in technology transfer, conference calls, and the sharing of technical information.
Coordinate front-end document requests with supporting departments.
Help ensure deviations and CAPAs are addressed promptly and batch-record revisions are reviewed and approved in a timely manner.
Seek and support improvements to the efficiency and effectiveness of document review and revision.
Follow GMP, GDP, SOPs, safety procedures, and regulatory requirements, and record data accordingly.
Attend weekly management meetings to discuss timelines and priorities, and contribute to projects to ensure timely completion.
Troubleshoot and prioritize moderately complex operational issues, including providing on-floor troubleshooting support as needed.
Ensure raw data records are accurate, complete, appropriately ordered, and compliant with protocol specifications and GMP requirements.
Review data generated or collected by less experienced technical staff.
Perform other duties as assigned and adhere to company values, policies, procedures, and business ethics.