Job Information
United Therapeutics Senior/Lead Associate, API Production/Synthetic Chemistry in Silver Spring, Maryland
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
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 at the Senior Associate level
This role will work on the production of active pharmaceutical ingredients (API) for three of United Therapeutics' commercial drugs and other drugs that are in the development phase. This person will perform the production in a kilo lab setting using specific procedures and batch records following US and International guidelines for good manufacturing practices (cGMP) to ensure high-quality production. This role may lead a team to complete all GMP manufacturing activities.
Perform production operations and complete production batch records, and other documents per cGMP
Operate production equipment such as reactors, filters, rotary evaporators
Clean production labs, general production areas, equipment, and glassware following their specific procedures
Dispose of hazardous chemical wastes in a safe and environmentally correct manner according to federal, state and local laws
Request and return the materials using STO process in SAP
Receive training in the functions and operations of the organization, company policies and regulations
Complete production planning and execution in SAP
Follow safety procedures, perform safety checking and maintain a safe work environment
Communicate with other UT departments and vendors related to API production requirements
Revise API Production SOPs and batch record
Oversee manufacturing batch
Write internal GMP manufacturing reports and present to colleagues on a regular basis
Perform other duties as assigned
For this role you will need
Minimum Requirements
6+ years of relevant small molecule pharmaceutical manufacturing experience with a H.S. Diploma/GED or Associates Degree or
4+ years of relevant small molecule pharmaceutical manufacturing experience with a Bachelors Degree
Basic use of Microsoft Office Software Programs
cGMP knowledge
Knowledge of basic organic chemistry lab techniques
Preferred Qualifications
Bachelor’s Degree in chemistry or related field
Troubleshooting of minor production equipment issues
Operation of 50-400L production equipment
Handling of hazardous chemicals
Basic use of SAP
Ability to communicate effectively with supervisors, peers, employees
How you'll contribute at the Lead Associate Level
Responsible for performing and managing the production of active pharmaceutical ingredients (API) for three UT's commercial drugs and other development products. This role will lead a team to perform production in kilo lab setting using specific procedures and batch records following US and international guidelines for good manufacturing practices (GMP) ensuring high quality products.
Perform production operations and complete batch records according to cGMP guidelines
Operate production equipment such as reactors, filters, rotary evaporators
Clean production equipment, labs and general production areas
Dispose of hazardous chemical wastes in a safe and environmentally correct manner according to federal, state and local laws
Follow safety procedures, perform safety checking and maintains a safe work environment
Complete production planning and execution in SAP
Receive training in the functions and operations of the organization, company policies and regulations
Analyze results according to established principles and procedures
Communicate with other UT departments and vendors related to API production requirements
Revise API Production SOPs and batch records
Complete Change Control and deviation investigation
Lead a team to complete all GMP manufacturing activities
Perform GMP materials purchasing
Write internal GMP manufacturing reports and present to colleagues on a regular basis
Perform other duties as assigned
For this role you will need
Minimum Requirements
8+ years of relevant small molecule pharmaceutical manufacturing experience with a H.S. Diploma/GED or Associates Degree or
6+ years of relevant small molecule pharmaceutical manufacturing experience with a Bachelor's Degree
Ability to communicate effectively with supervisors, peers, employees
Basic use of Microsoft Office Software Programs
Knowledge of basic organic chemistry lab techniques
cGMP knowledge
Preferred Qualifications
Bachelor’s Degree in chemistry or related field
Troubleshooting of minor production equipment issues
Operation of 50-400 L production equipment
Handling of hazardous chemicals
Basic use of SAP and trackwise digital
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
We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.
United Therapeutics
- United Therapeutics Jobs