Manufacturing Science & Technology Specialist II​/Senior Specialist

California, US residents .

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

The MS&T Specialist II/Sr. Specialist is responsible for supporting manufacturing in a commercial operations environment. This position is responsible for assisting in the investigation and resolution of manufacturing deviations, non-conformances, and out-of-specification results, supporting the execution of manufacturing change controls, assisting in process development and optimization studies, troubleshooting manufacturing issues, and ensuring the smooth transfer of new products and processes into commercial production.

The Specialist II/Sr. Specialist will work closely with manufacturing, quality, engineering, regulatory, and validation teams to ensure robust, efficient, and compliant pharmaceutical operations.

* Assist in the investigation and resolution of manufacturing deviations, non-conformances, and out-of-specification results

* Support root cause analysis efforts for process-related issues, providing data and technical insights

* Support in the execution of manufacturing change controls

* Perform process monitoring & data analysis to monitor process performance, identify trends, and support continued process verification

* Participate in process improvement initiatives to enhance yield and efficiency

* Partner cross-functionally with Engineering, Manufacturing, Quality, Automation, Validation, and Regulatory teams on manufacturing process and equipment projects

* Aid in the technology transfer of new pharmaceutical processes/products to manufacturing

* Contribute to the preparation of process documentation, including batch records, SOPs, and technical reports

* Contribute technical expertise for regulatory filings and assist during internal and external audits

Minimum Requirements

Manufacturing Science & Technology Specialist II

* Bachelor's Degree in biology, chemistry, biochemistry, or closely related field

* 2+ years of experience in biopharmaceutical industry, with a knowledge of cGMP regulations

* Familiarity with investigational tools such as Fishbone diagrams, 5 Why's, and Failure Mode and Effects Analysis to solve manufacturing deviations

* Ability in experiment planning, design, execution, optimization, data analysis, interpretation, and communication

* Basic knowledge of GXP guidelines for the biotech industry

* Proficient technical writing skills for preparation of summary reports

* Good organizational skills

* Ability to interpret data critically

* Familiar with Microsoft Office and other common software tools

Preferred Qualifications

* Master's Degree in biology, chemistry, biochemistry, or closely related field

* 5+ years of experience in biopharmaceutical industry, with a knowledge of cGMP regulations

* Experience with design of experiment studies and software for process optimization

* Familiarity with Fill Finish processes

* Familiarity with Cell Culture and Purification processes

* Ability to perform statistical evaluation of data

* Hands-on experience with specific equipment categories such as bioreactors, purification skids, and fill-finish lines

* Ability to perform basic maintenance of equipment

* Experience with scale-up small scale cell culture and transfer to a cGMP facility for full scale manufacturing

* Understanding of validation lifecycle principles and regulatory guidance

* Familiarity with Benchling or other electronic laboratory notebook software

Minimum Requirements

Sr. Manufacturing Science & Technology Specialist

* Bachelor's Degree in biology, chemistry, biochemistry, or closely related field

* 5+ years of experience in biopharmaceutical industry, with a knowledge…