Lead Aseptic Manufacturing Technician

Proclinical is seeking a Lead Aseptic Manufacturing Technician for a leading immune-oncology company located in Philadelphia, PA. The companies lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma.

Job Responsibilities:

• Develop a comprehensive understanding of and be able to proficiently execute Iovance's current cell therapy manufacturing process, as this role is viewed as a subject matter expert within specific area.
• Support management with the alignment of manufacturing processes with technical training and ensure consistent alignment between the processes. Supports technical transfer and additional research level testing activities.
• Deliver training sessions and ensure training documentation is maintained. Ensure training schedules meet company production and quality targets.
• Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
• Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of processing.
• Understands and complies with quality standards and requirements as documented. 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.
• Support documentation needs, which may including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Contribute to department operations improvement in areas such as document revisions and department inspections.
• Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements. Review documentation of functions performed as part of quality control requirements. Review data as generated/collected by less experienced technical staff.
• 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.
• Attends the daily lab meeting and escalates issues/concerns at that forum to Area Management for further investigation.
• May work on assignments that are moderately complex in nature, where judgment is required to troubleshoot and resolve operational issues without negatively impacting manufacturing efforts.
• Other duties as assigned.

Skills and Requirements:

• Minimum bachelor's degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
• Minimum of 4 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing. Cell therapy experience preferred.
• 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.
• Strong knowledge of and experience in in-lab skills training, including aseptic technique and cell culture processing.
• Experience leading "development" initiatives, i.e., training, coaching, learning initiatives.
• 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 (potentially 50+ employees) representing a variety of personalities and experience levels.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
• 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.
• Understands and complies with quality standards and requirements as documented.
• Must have strong written and verbal communication and organizational skills.
• Familiarity with data and sample management required (LIMS/MES)
• Able to work independently with minimal supervision.
• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).

If you are having difficulty in applying or if you have any questions, please contact Sam Jankura at (+1) (617) 671-0335 or S.Jankura@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-SJ1