Manufacturing Associate IV, Clinical - United States
The Clinical Manufacturing Associate IV is responsible for performing manufacturing operations according to standard operating procedures and batch instructions without supervision. The Clinical Manufacturing Associate IV is also responsible for supporting technology transfer initiatives to ensure successful scale-up of processes and bulk production of novel drug therapies. (or something like that)..
- Embrace Core Competencies
- Ensure a safe working environment for all staff
- Perform simple, routine, complex, and critical operations in accordance with cGxP’s.
- Perform and document operations in accordance with cGxP’s
- Lead production activities and off-the –floor projects.
- Troubleshoot and resolve operational problems while processing
- Represent Clinical Manufacturing in cross functional initiatives and meetings
- Execute technology transfer activities to ensure that potential scale-up conflicts are resolved
- Translate process development reports into workable standard operating procedures and master batch records
- Routinely draft and revise standard operating procedures and master batch records to make process improvements.
- Be able to perform deviation investigations and closure, including determination of root cause analysis and product impact analysis.
- Interact independently with regulatory agencies
- Develop and provide training on complex manufacturing processes
- Perform Manufacturing review and approval of critical documents
- Develop process validation protocols and lead execution activities
- Analyze complex problems and determine and implement solutions
- Monitor and evaluate process trends and recommend and implement continuous improvement strategies as appropriate
- Manage multiple projects independently
- Ensure manufacturing process equipment is appropriately maintained and troubleshoot issues as necessary
- Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
- Train less knowledgeable staff members
- Communicate effectively, written and verbal
- Maintain training compliance
- Perform data collection, compilation, and statistical analysis
- Interact with vendors and outside resources
- Plan and implement complex changes
- Support and embrace the Integrated Management System to enable workplace efficiencies
- Must be able to work within and adapt to complex electronic systems such as SAP and Trackwise
- Must be able to read, write and converse in English
- Must have good working knowledge of MS Excel and Word
- Ability to work in an intense, fast-paced work environment
- Ability to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously
- Ability to work independently and as part of a team
- More than 8 years experience in a cGxP biopharmaceutical manufacturing environment
- Must be able to commit to an undefined production schedule that includes weekend and off-shift hours. Must routinely perform all activities outlined in the associated Job Hazard Assessment.
- BA/BS in a scientific discipline or equivalent experience preferred.
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
- As the global leader in complement inhibition, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders
- In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas