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Manufacturing Operations Specialist
2 months ago
Position Summary:
Iovance Biotherapeutics Inc. is at the forefront of immune-oncology, dedicated to innovating and commercializing advanced cancer immunotherapies derived from Tumor Infiltrating Lymphocytes (TIL). Our flagship product is a personalized, ready-to-administer cell therapy that has shown remarkable effectiveness in treating metastatic melanoma. We are expanding our manufacturing capabilities to support the development and launch of our promising therapeutic candidates.
Key Responsibilities:
- Assist in the preparation and approval of essential documentation, including Standard Operating Procedures (SOPs), Batch Records, and reports on deviations and corrective actions.
- Lead investigations into nonconformances and deviations, employing structured root cause analysis to ensure timely resolution.
- Manage change controls related to manufacturing processes and equipment.
- Engage in technology transfer and facilitate technical discussions.
- Coordinate documentation requests with relevant departments to ensure seamless operations.
- Ensure timely addressing of deviations and corrective actions, along with prompt review and approval of Batch Records.
- Continuously explore and implement innovative practices to enhance the efficiency of document management.
- Comply with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), ensuring accurate data recording to meet regulatory standards.
- Participate in weekly management meetings to align on timelines and priorities.
- Contribute to project initiatives to ensure timely execution of tasks.
- Handle moderately complex assignments requiring sound judgment to resolve operational challenges without disrupting manufacturing activities.
- Provide troubleshooting support and prioritize tasks to address complex issues as needed.
- Work collaboratively in a team setting while also demonstrating the ability to operate independently.
- Ensure raw data integrity and compliance with protocol specifications and GMP requirements, reviewing data generated by junior staff.
- Adhere to Iovance Biotherapeutics' core values and ethical standards.
- Follow safety protocols and laboratory procedures in accordance with company policies and regulations.
- Perform additional duties as assigned.
Travel Requirements:
- Occasional travel may be necessary, not exceeding 10% of the time.
Qualifications:
- Bachelor's degree in biology, biochemistry, bioengineering, or a related field, or equivalent industry experience.
- A minimum of 2 years of experience in GMP manufacturing within the biopharmaceutical sector.
- Strong technical knowledge of aseptic processing in cleanroom environments is essential.
- Proven ability to build relationships and provide exceptional support across diverse teams.
- Self-motivated, results-driven individual with demonstrated leadership capabilities in a complex manufacturing setting.
- Adaptability to manage change and ambiguity effectively.
- Experience working in a fast-paced, collaborative environment.
- Familiarity with regulatory standards, including 21 CFR Part 11 and GxP best practices.
- Excellent communication skills, both written and verbal.
- Strong organizational skills and attention to detail, with proficiency in data management systems.
- Ability to work independently with minimal supervision.
- Compliance with Iovance Biotherapeutics' core values and policies is mandatory.
- Proficiency in English and Microsoft Office applications is required.
Physical and Mental Demands:
- Ability to wear cleanroom attire and personal protective equipment (PPE).
- Physical capability to stand and walk for extended periods, including the ability to lift up to 45 pounds.
- Strong analytical and problem-solving skills, with the ability to manage multiple priorities and meet deadlines.
Work Environment:
- This role involves working in both office and cleanroom settings, with potential exposure to various chemicals and biological materials.
- Must be prepared to work in environments with biohazards and adhere to safety protocols.
Iovance is committed to fostering a diverse and inclusive workplace. We are an equal opportunity employer, and all qualified applicants will be considered without regard to race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.
