Manufacturing Specialist I

Role Summary

Manufacturing Specialist I provides operational support in a GMP manufacturing environment with a focus on documentation control, deviation investigations, and change controls. The role includes coordinating technology transfer, managing front-end document requests, and ensuring timely, compliant data recording and batch record revisions. The position requires collaboration with cross-functional teams, adherence to quality systems, and the ability to work independently or in a team to solve moderately complex problems.

Responsibilities

• Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Lead teams investigating minor, major and critical nonconformances and deviations, including gathering information through structured root cause analysis. Draft and revise deviation reports as needed to assure that deviations are addressed in a timely manner.
• Own and manage change controls associated with manufacturing areas and equipment.
• Participate in technology transfer, conference calls and sharing of technical information.
• Coordination of front-end document requests with supporting departments.
• Assure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records revisions are reviewed and approved in a timely manner.
• Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of document review and revision.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Attends the weekly management meeting to discuss timelines and weekly priorities.
• Contribute to projects to ensure timely initiation and completion of work.
• May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
• Troubleshoot issues and prioritize workload to solve moderately complex problems, including on the floor troubleshooting support as needed.
• Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements. Review data as generated/collected by less experienced technical staff.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.

Travel

May require up to 10% travel, based on business need.

Qualifications

• Required: Minimum bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
• Required: Minimum of 2 years of experience in biopharmaceutical GMP manufacturing operations.
• Required: An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Required: Demonstrated strong technical knowledge of aseptic processing in cleanroom environments.
• Required: Ability to build relationships quickly and credibly. Provide consistent, excellent support to staff, with the ability to influence large teams within the manufacturing department representing a variety of personalities and experience levels.
• Required: Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
• Required: Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
• Required: Ability to work successfully in a fast-paced, team-oriented environment.
• Required: Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Required: Excellent presentation skills, both written and verbal.
• Required: Understands and complies with quality standards and requirements as documented.
• Required: Must have strong written and verbal communication and organizational skills.
• Required: Strong computer skills, problem solving and attention to detail.
• Required: Familiarity with data and sample management required (LIMS/MES).
• Required: Able to work independently with minimal supervision.
• Required: Must adhere to Iovance Biotherapeutics core values, policies, procedures, and business ethics.
• Required: Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).

Skills

• Strong written and verbal communication, presentation, and interpersonal skills.
• Analytical thinking, problem-solving, and attention to detail.
• Proficiency with Microsoft Office Suite and data management tools; familiarity with LIMS/MES.
• Ability to influence cross-functional teams and manage multiple priorities.
• Adaptability in a fast-paced manufacturing environment.

Education

• Bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.

Additional Requirements

• Travel: May require up to 10% travel, based on business need.
• Physical Demands: Must wear appropriate clean room attire and all Personal Protective Equipment (PPE); stand and/or walk approximately 90%/10% (may include climbing ladders or steps); crouch, bend, twist, reach, and perform repetitive motions; lift and carry objects weighing up to 45 pounds.
• Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, discretion; ability to handle work-related stress; ability to handle multiple priorities and meet deadlines.
• Work Environment: Office and manufacturing cleanroom setting; exposure to chemical/biochemical exposures; latex and bleach; biohazards, human blood components, and chemicals; potential exposure to noise and equipment hazards and strong odors.