613711 Lead Aseptic Manufacturing Technician
6-month initial contract
Philadelphia, PA
Shift update:
Sunday to Wednesday or Wed to Saturday schedule.
4x10 and 3x12 (schedule rotates from week to week).
Overview
The Lead Aseptic Manufacturing Tech role helps provide guidance and leadership to the Aseptic Manufacturing Technicians’ teams. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. The Lead Manufacturing Technician will be responsible for and lead others in various tasks, such as cleaning, sanitization, preparation, and fulfilling products for commercial and clinical use. To excel in this role, the candidate strongly desires a background in cell culture, aseptic gowning, qualification, and ISO class 5 cleanroom operations. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime on weekends and holidays to complete the manufacturing process successfully.
Essential Functions and Responsibilities
- Develop a Subject Matter Expert (SME)-level understanding of and can execute as skillfully as well as troubleshoot GMP cell therapy manufacturing process(es).
- Assists with identifying training needs, establishing a feedback loop to ensure continuous improvement.
- Deliver training sessions and ensure training documentation is maintained.
- Understand and comply with quality standards and requirements as documented. Ensure training schedules meet company production and quality targets.
- Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
- Perform document review, including executed Batch Records and Logbooks.
- Support documentation needs, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to reflect current procedures accurately.
- Execute documentation Change Controls of SOPs, Batch records, etc., as needed.
- Support interdepartmental and departmental projects in a contributor capacity.
- Supports technical transfer and additional research-level testing activities as needed.
- May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.
- Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
- Completes recording of data to comply with regulatory requirements.
- Attend or hold the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
- Ability to work in a team environment and independently as required.
- Works on routine assignments per written procedures, where the ability to recognize deviation from accepted practice is required.
- Work in a cleanroom with biohazards, human blood components, and chemicals
- Must adhere to 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 – 5%
Required Education, Skills, and Knowledge
- Bachelor's degree or some post-secondary education.
- Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
- Ability to mentor and provide best practices to other team members.
- Must be able to work with ambiguity – ready to change gears and plans quickly and manage constant change.
- Must be able to read, write and understand English for Good Documentation Practices
- Proficient with computers and Microsoft (Excel, Word, Outlook) programs.
- Ability to perform arithmetic calculations accurately and reproducibly, including fractions, decimals, percentages, and basic algebraic and geometric calculations.
- Ability to build relationships quickly and credibly.
- Ability to work successfully in a fast-paced, team-oriented environment.
Preferred Education, Skills, and Knowledge
- 3+ years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulatrion
- Proactive, results-oriented, self-starter with experience in a complex manufacturing environment
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.
For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following:
- Must not be color blind
- Must have 20/20 near vision in both eyes (can be corrected)
- Clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish color
Physical Demands and Activities Required:
- Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
- Must meet requirements for and be able to wear a half-face respirator
- Able to stand and/or walk 90% (and sit 10%) for the scheduled workday, which may include climbing ladders or steps.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motion
- Must be able to lift and carry objects weighing 45 pounds
Mental
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment
This position will work in both an office and a manufacturing lab setting. When in the lab, must be able to work in a Lab setting with various chemical/biochemical exposures, including latex and bleach, and potential exposure to noise and equipment hazards and strong odors.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They do not constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the position’s responsibilities at any time.
***Pay rate is commensurate with experience. Target pay rate is $40/hr.***
