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 documentation and quality processes, including standard operating procedures, batch records, deviations, CAPAs, and change controls. The role also supports technology transfer, coordinates document requests, and helps improve document review and revision processes. The position works on routine and moderately complex manufacturing assignments, troubleshooting operational issues and supporting the manufacturing floor as needed. The specialist ensures data and records meet GMP and regulatory requirements, reviews records generated by less experienced technical staff, and contributes to projects and weekly planning. The work takes place in both an office and a manufacturing cleanroom setting. The role is for regular first-shift weekday hours, Monday through Friday, and may require up to 10% travel based on business need.

Requirements

Bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or a related technical field, or equivalent industry experience; an equivalent combination of education and experience may substitute.
At least 2 years of experience in biopharmaceutical GMP manufacturing operations.
Strong technical knowledge of aseptic processing in cleanroom environments.
Ability to build relationships, support staff, and influence teams with varied personalities and experience levels.
Proactive, results-oriented self-starter with leadership skills and experience in a complex manufacturing environment.
Ability to adapt to ambiguity and changing plans, and work successfully in a fast-paced, team-oriented environment.
Quality mindset and familiarity with 21 CFR Part 11, GxP best practices, and FDA regulations.
Excellent written and verbal communication and presentation skills, plus strong organizational skills.
Strong computer skills, problem-solving ability, and attention to detail.
Familiarity with data and sample management systems (LIMS/MES).
Ability to work independently with minimal supervision and as part of a team.
Ability to read, write, and understand English; proficiency in Microsoft Excel, Word, and Outlook.
Ability to wear cleanroom attire and personal protective equipment, including scrubs, gowning coveralls, masks, and gloves.
Ability to stand or walk 90% of the time and sit 10% of the time, including possible climbing of ladders or steps.
Ability to crouch, bend, twist, reach, and perform repetitive motions.
Ability to lift and carry objects weighing up to 45 pounds.
Ability to work in cleanrooms with chemical and biochemical exposures, including latex and bleach, as well as biohazards and human blood components; potential exposure to noise, equipment hazards, and strong odors.
Ability to meet the role’s mental demands, including conceptual thinking, judgment, troubleshooting, problem-solving, analysis, discretion, handling work-related stress and multiple priorities, and meeting deadlines.

Responsibilities

Support drafting, approval, and revision of SOPs, batch records, deviation reports, CAPAs, and related documentation.
Lead investigations of minor, major, and critical nonconformances and deviations, including gathering information through structured root cause analysis.
Own and manage change controls associated with manufacturing areas and equipment.
Participate in technology transfer, conference calls, and sharing of technical information.
Coordinate front-end document requests with supporting departments.
Ensure deviations and CAPAs are addressed 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, SOP, GDP, safety, and regulatory requirements and accurately record data.
Attend weekly management meetings to discuss timelines and priorities.
Contribute to projects and help ensure work is initiated and completed on time.
Troubleshoot manufacturing issues, prioritize workload, and provide floor support as needed.
Ensure raw data records are accurate, complete, appropriately ordered, and meet protocol or GMP requirements; review data generated or collected by less experienced technical staff.
Comply with company values, policies, procedures, business ethics, Safety SOPs, SDS sheets, laboratory procedures, and OSHA regulations.
Perform other duties as assigned.