The Specialist I, Bioprocess will work within the Downstream Processing group. The Specialist I, Bioprocess will perform the following activities while executing downstream operations:
Preparation of solutions
Filtration
Chromatography
Tangential flow filtration
Homogenizing
Drug substance formulation
Drug product formulation
Drug product vial filling
The incumbent works cross-functionally with internal departments and external resources on gene therapy manufacturing related issues.
The incumbent performs essential job functions with no instruction and trains more junior level associates on the downstream operations.
The incumbent supports adherences to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
Executes routine extremely complex manufacturing assignments with a high degree of initiative and the ability to resolve problems and make recommendations as required.
Adheres to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures.
Performs routine to very complex mammalian cell culture using aseptic techniques. Monitors daily the mammalian cell cultures and bioreactors.
Weighs and checks raw materials, assembles and cleans process equipment, & monitors processes.
Delegates and ensures junior level associates complete work instructions and maintain a clean room environment to comply with regulatory requirements.
Operates all primary production equipment such as stainless-steel bioreactors, disposable bioreactors and other disposable equipment, and media preparation equipment. Leads troubleshooting activities for all equipment.
Authors and approves Master Batch Records (MBRs) by transferring technical information from scientific and development document.
Collaborates and delegates with equipment and instrument vendors to authorize revisions to existing SOPs and approves SOPs for such equipment.
Leads, Champions or Advises on Operational Excellence cross-functional project teams, including but not limited to Development, Quality, Analytics, Logistics, Facilities and Document Center. Effectively uses Continuous Improvement and Project Management tools with mastery for completion of projects.
Investigates low (Level III) and medium risk (Level II) deviations for root cause. Recommends corrective actions (CA) and preventative actions (PA). Reviews and approves recommended CA and PA from junior level associates. Monitors and advises on CAPA implementation and ensures junior level associates comply with agreed upon timelines.
Leads and advises on the design and implementation of single use technology process consumables for new molecule facility fit and continuous improvement.
Conducts and reviews the results of Safety and GMP self-auditing walkthroughs and observations ensuring junior level associates comply with assignment and closure dates.
Logs and advises junior level associates on logging and submitting samples in Laboratory Information Management Systems (LIMS). Tracks results and compiles data. Performs analyst role entering results from outside testing facilities into LIMS.
Reviews and signs-off on completed batch records and ensures junior level associate’s reviews are accurate and performs SAP adjustments. Performs Technical Review and signs off on all executed records. Coordinates the tracking and return of executed MBRs to the Quality department.
Plans the daily work to be executed based on outline schedule from Management. Adjusts schedule as needed. Ensures weekend coverage. Ensures planned work is executed on schedule.
Coordinates with management and technology transfer teams to ensure ordered materials are accurate. Monitors future needs against approved material supply to alert Logistics of shortfalls. Alerts management to potential issues that would impact processing or the schedule.
Coordinates shipment of outside contract testing laboratories with Logistics and management. Review reports from outside labs.
Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
Describe the following criteria, which are necessary to effectively perform the position:
* Minimum level of education and years of relevant work experience.
Bachelor’s degree in Science or Engineering with a minimum of 5 years relevant experience or an Associate’s degree in Science or Engineering with a minimum of 7 years relevant experience or High School diploma with a minimum of 9 years relevant experience.
Ability to follow written instructions and procedures.
Attention to detail is critical
* Special knowledge or skills needed and/or licenses or certificates required.
Proficiency with Microsoft Office.
Excellent verbal and written communication and skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
*Special knowledge or skills and/or licenses or certificates preferred.
N/A
* Travel requirements
0%
*Physical requirements (only note if the job requires physical capacity beyond general office work)
Laboratory based position
**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
