ReciBioPharm, the biologics business unit of Recipharm AB, is a visionary contract development and manufacturing organization (CDMO) that partners with companies seeking to develop and manufacture complex biological drugs and innovative therapies. Our dedicated team, state-of-the-art facilities, and unparalleled resources are crucial for advancing products from development to commercial launch. Our vision is to be the trusted and innovative CDMO partner for advanced therapy pioneers, so that we can bring life-changing therapeutics to patients. We partner with our clients to make treatments that can benefit vast patient populations, working across many indications. ReciBioPharm’s mission is to change healthcare through our intrepid and daring team engaging with clients to develop, manufacture, and supply breakthrough therapies that transform lives.
JOB SUMMARY
The Manufacturing Associate I-III will perform daily cGMP manufacturing for one or several of the following: plasmids, mRNA or microbiome LBPs products including upstream, purification, media/buffer production, DP and general suite/operational readiness activities. The ideal candidate will enjoy working in a team-oriented environment with minimal supervision.
We are currently hiring for 2nd shift, which operates from 3:00 PM – 11:30 PM
ESSENTIAL JOB FUNCTIONS
- Accurate product preparation following approved Manufacturing Batch Records and SOPs
- Documentation of all activities in Batch Records, Logbooks, Forms, etc. and electronic interfaces
- Maintain the highest standards of workplace Safety and product quality
- Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
- Identifies, escalates and documents events and deviations and subtle variances that deviate from normal operation; participate as needed in investigations.
- Demonstrates ability to troubleshoot basic mechanical operations.
- Work in accordance with site and company EHS programs.
- Work in accordance with regulations, detailed protocols, Batch Records, SOPs and Work Instructions
- Follows gowning and materials movement procedures
Experience and Skills
- High School/Technical Degree with 3+ years relevant experience OR
- Bachelors in a Scientific, Engineering, Biology or related field
- Operational Excellence, such as 6S, experience a plus.
- SOP, MBR, Deviations, CAPA authoring/editing is a plus.
- Working knowledge of Microsoft Outlook, Word and Excel required.
- Good laboratory skills and excellent record keeping, including GDP, is required.
- Ability to work independently and stay on task in a fast-paced environment without direct supervision.
- Flexibility to support processing off-hours.
- Ability to work well with others in a collaborative team environment.
- Regular and reliable performance and attendance required.
- Team player
- Ability to handle multiple tasks while remaining focused
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear
- The employee is required to walk; climb or balance; and stoop, kneel, crouch, or crawl
- The employee must frequently lift and/or move up to 20 pounds and occasionally lift and/or move up to 50 pounds
- Specific vision abilities required by this job include close vision, color vision, ability to adjust focus, and a minimum 20/20 vision with or without corrective lenses. Eye exam and visual inspection qualification will be required to confirm vision capabilities at appropriate level.
- Operation of large scale and delicate machinery
- Repetitive motion that includes wrists, hands, and fingers
- No travel required.
- Communicate using telephone and e-mail
- This will be a manufacturing suite-based position that will require some clerical work on a computer to provide supervision and support of manufacturing activities, while working on documentation to support job functions listed above
Who We Are
ReciBioPharm hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.
Here at ReciBioPharm, we embrace ALIVE – our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging. Are you ready to come ALIVE with a daring and intrepid team? Don’t wait another minute; Apply today!
MEDICAL REQUIREMENTS
- This position requires a criminal background check and drug screening.
- COVID19 Vaccine required to come on site; Individuals seeking an exemption from this requirement for medical or religious reasons should reach out to Human Resources for an accommodation.
Benefits
ReciBioPharm offers a very competitive benefits package including medical, dental, vision, prescription drug coverage, life and disability insurance, 401(k), and generous vacation and time off policies among other attractive benefits. We operate in a world class facility to attract the best and brightest talent to work collaboratively in our mission to bring novel therapies to the patients who need them most.
ReciBioPharm is an Equal Opportunity Employer.
