Manufacturing Specialist

at  Iovance Biotherapeutics Inc

Overview
Iovance Biotherapeutics is seeking a Manufacturing Specialist to join the Operations team at 700 Spring Garden St, Philadelphia, PA. Co-located at the American Red Cross Penn Jersey Region, this Iovance facility produces a critical raw material used in the company’s tumor infiltrating lymphocyte (TIL) process. The critical raw material is processed from leukapheresis units and frozen. Processing is performed in an ISO 7 cleanroom within an ISO 5 biological safety cabinet.
Iovance is an immune-oncology company focused on the development and commercialization of novel cancer immunotherapies based on TIL. The company’s lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. The company has Phase 2 clinical trials in progress for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors. The company currently is developing its commercial manufacturing capacity to support development and launch of these assets.

BASIC QUALIFICATIONS

• Minimum bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
• Minimum of 5 years of experience in biopharmaceutical based GMP manufacturing operations.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Demonstrated strong technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to mentor and provide best practices to other members of the team.
• Ability to build relationships quickly and credibly. Provide consistent, excellent support to staff, with the ability to influence large teams within the manufacturing environment representing a variety of personalities and experience levels.
• Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment. Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
• Ability to work successfully in a fast-paced team-oriented environment.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Excellent presentation skills, both written and verbal.
• Understands and complies with quality standards and requirements as documented.
• Must have strong written and verbal communication and organizational skills.
• Strong computer skills, problem solving and attention to detail.
• Able to work independently with minimal supervision.
• Must adhere to Iovance Biotherapeutics core values, policies, procedures and business ethics.
• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
  The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

• Investigate manufacturing deviations, working with cross-functional teams to gather data, lead and perform Root Cause Analysis to determine the likely root cause of the event. Identification of Corrective and Preventative actions to prevent recurrence. Ensure that deviations are addressed in a timely manner.
• Lead (act as project manager for) teams investigating major and critical deviations, including gathering information through structured root cause analysis.
• Write, review, and edit technical documents, including drafting and approval of SOPs, Batch Records, CAPAs, Change Controls, etc. Perform basic revisions as needed to accurately reflect current procedures. Review and edit documents created by other team members for accuracy, clarity, and consistency.
• Trending of monthly metrics, and “Health of the Operation”
• Participate in technology transfer, conference calls, and sharing of technical information.
• Coordination of front-end document requests with supporting departments.
• 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.
• Ensure that all documentation is compliant with internal requirements, regulatory requirements, including FDA, EMA, and ISO standards.
• Attends the weekly management meeting to discuss timelines and weekly priorities.
• Manage 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.
• 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.
• Other duties as assigned.