California, US residents click here. The job details are as follows:What We Do. We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conduct... more details
California, US residents click here.
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
The Senior Manufacturing Associate, Purification is responsible for supporting the manufacture of monoclonal antibody products under cGMP regulations. This role will troubleshoot process and equipment issues and maintain training documentation including SOPs. This role will utilize expertise to train other operators in cGMP compliance and processing.
- Operate bioprocess equipment under strict adherence to cGMP, OSHA and Unither policies and regulations under general supervision ensuring that the production areas and all equipment are clean and in orderly operating condition
- Weigh raw materials per Production Batch Records specifications to ensure buffers are properly formulated
- Prepare buffers from stock raw materials per batch records specifications
- Work on moderate to complex assignments per written procedures and batch records with limited supervision
- Monitor and audit work processes, ensure components, materials and supplies are stocked prior to the start of the process operations to ensure compliance and completion of targets
- Write area SOPs and production batch records
- Collaborate with process development on technical transfer issues and may support and/or lead areas for process improvement
- Review and/or execute all required documentation for proper traceability of a production lot and adhere to cGMP and SOPs
- Provide relevant process, cGMP, and safety training to junior level staff and contractors
- Maintain personal cGMP training to ensure compliance
- Identify, develop, and recommend process improvements related to production to management
- Identify and perform moderate to complex troubleshooting of technical issues related production equipment, including but not limited to the pH meter, nanodrop, and other major equipment. Perform routine standardization and functional checks for process instrumentation for daily use in production on an intermediate level.
- Participate in all aspects of moderate to complex process deviations from initiation to closure
- Assist senior staff in implementing different projects related to production
- Perform On the Job Training (OJT) for new and developing staff
- Provide guidance to junior staff when running batches in the production process
- Other duties as assigned
For this role you will need
Minimum Requirements
- H.S. Diploma or General Education Degree (GED)
- 6+ years of related biotech and dedicated downstream manufacturing experience with a H.S. Diploma/GED or AA/AS or
- 4+ years of related biotech and dedicated downstream manufacturing experience with a BA/BS
- 3+ years of demonstrated downstream purification experience in monoclonal antibody products
- 3+ years of experience operating with chromatography systems in an operation (pilot scale or higher)
- 3+ years of experience with Tangential Flow Filtration (TFF) in an operation (pilot scale or higher)
- 3+ years of experience with solution preparation
- Strong cGMP documentation practices
- Ability to work shifts to cover a 24/7 operation
- Knowledge of Trackwise or similar process deviation/excursion documentation platforms
- Ability to objectively, accurately, and thoroughly convey complex and technical issues verbally
- Demonstrated ability to work effectively in a team
- Proficiency with Microsoft Office Suite
- Strong verbal and written skills
Preferred Qualifications
- Associates Degree in a scientific discipline or a related field or
- Bachelor’s Degree in a scientific discipline or a related field
- 2+ years of experience in Column Packing
- 2+ years of demonstrated experience operating equipment including depth filtration, nanofiltration, pumps, mixers, product hold tanks, laminar airflow, bulk filtration and viral filtration
- 2+ years of experience running and troubleshooting bioreactors
- Familiar with SAP or similar inventory management system
How you’ll contribute
The Lead Manufacturing Associate, Purification is responsible for leading the manufacture of monoclonal antibody products under cGMP regulations. In this role, you will troubleshoot process and equipment issues and maintain training documentation including SOPs. Using your expertise as a Lead Manufacturing Associate, you will also train other operators in cGMP compliance and processing.
- Operate bioprocess equipment under strict adherence to cGMP, OSHA and Unither policies and regulations under limited supervision ensuring that the production areas and all equipment are clean and in orderly operating condition.
- Weigh raw materials per Production Batch Records specifications to ensure buffers are properly formulated
- Prepare buffers from stock raw materials per Production Batch Records specifications
- Monitor and audit work processes to ensure compliance and completion of target
- Ensure components, materials, and supplies are stocked prior to the start of the process operations to ensure compliance and completion of targets
- Work on complex assignments per written procedures and batch records with limited supervision
- Review and/or execute related process documentation for proper traceability of a production lot and adhere to cGMP and SOPs
- Maintain personal cGMP training to ensure compliance
- Collaborate with process development on technical transfer issues. May lead areas for process improvement
- Work on problems of moderate/advanced scope with analysis of situations or data
- Identify, develop and implement process improvements
- Troubleshoot and resolve production problems of moderate/advanced complexity
- Participate in all aspects of complex process deviations, investigations, change controls, and corrective actions
- Conduct relevant process, cGMP and safety training
- Write and review area SOPs and Production Batch Records
- Perform and/or supervise daily cleaning and sanitization of the manufacturing equipment
- Assist senior staff in implementing different projects
- Provide guidance to junior staff when running batches
- All other duties as required
For this role you will need
Minimum Requirements
- H.S. Diploma or General Education Degree (GED)
- 8+ years of related biotech and dedicated downstream manufacturing experience with a H.S. Diploma/GED or AA/AS or
- 6+ years of related biotech and dedicated downstream manufacturing experience with a BA/BS
- 4+ years of demonstrated downstream purification experience in monoclonal antibody products
- 4+ years of experience operating with chromatography systems in a large-scale operation (pilot scale or higher)
- 4+ years of experience with Tangential Flow Filtration (TFF) in a large-scale operation (pilot scale or higher)
- 4+ years of experience with solution preparation
- Strong cGMP documentation practices
- Ability to work shifts to cover a 24/7 operation
- Demonstrated ability to work effectively in a team
- Strong verbal and written skills
- Experience in supporting written deviations and conducting area investigations
- Ability to objectively, accurately, and thoroughly convey complex and technical issues verbally
- Proficiency with Microsoft Office Suite
- Familiarity with SAP or similar management system
- Knowledge of Trackwise or similar process deviation/excursion documentation platforms
Preferred Qualifications
- Associates Degree in a scientific discipline or related field or
- Bachelor’s Degree in a scientific discipline or related field
- 3+ years of experience in Column Packing
- 3+ years of demonstrated experience operating equipment including depth filtration, nanofiltration, pumps, mixers, product hold tanks, laminar airflow, bulk filtration and viral filtration
- 3+ years of experience running and troubleshooting chromatography and TFF systems
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
