Openings for multiple levels: II, Senior, and Lead
Shift: Wednesday - Saturday, 4 days a week, 10 hour days
Pay between $31.75-$40 based on experience
6 month contract to hire
Specific Responsibilities
- Develop a comprehensive understanding of and be able to proficiently execute current cell therapy manufacturing process.
- Complete training sessions and ensure training documentation is maintained.
- Understands and complies with quality standards and requirements as documented.
- Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
- Supports technical transfer and additional research level testing activities.
- 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. Perform basic revisions as needed to accurately reflect current procedures.
- Attends the daily lab 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 ability to recognize deviation from accepted practice is required.
- Other duties as assigned.
Qualifications
- Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
- 0-5 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
- Demonstrated 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.
- 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 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.
- Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
- May require up to 5% travel, based on business need.
Physical Requirements
- Must be able to work in environment with variable noise levels
- Must be able to work in Lab setting with Biohazards /various Chemicals
- Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
- Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards and strong odors.
- Ability to stand/sit/walk for long periods of time
- Ability to crouch, bend, twist, reach, and perform activities with repetitive motions
- Ability to lift 20 lbs