Proclinical is seeking a Manufacturing Lead for a leading biopharmaceutical company located in Philadelphia, PA.
Must be eligible to work or be a citizen in the US.
- Develop a comprehensive understanding of and be able to proficiently execute company'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.
If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at (+1) 267-297-3280 or firstname.lastname@example.org.
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.