Senior Manager, Manufacturing Cell Production

California, US residentsclick here.

The job details are as follows :

Sr Manager Manufacturing Cell Production

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.

With over 100,000 patients on the organ transplant waitlist and only a fraction receiving the lifesaving organ they require, there is a great need for additional sources of transplantable organs.

At Miromatrix, a leader in regenerative medicine and a subsidiary of United Therapeutics Corporation, we are working to address this unmet need by bioengineering human organs to help save and improve patients’ lives.

Join our team as we continue to make history by developing life-saving therapies to help patients with liver and kidney disease.

How you’ll contribute

The primary job functions and responsibilities of the Senior Manager, Manufacturing Cell Production include effective management of a team of Bioprocess Technicians and general manufacturing management.

This role will ensure logistics are effectively coordinated, adhere to budgets, and assist in the development and completion of team objectives.

This position will support general departmental training, order supplies, perform document review and revision, and lead collaborations with the Quality department.

This position will communicate resource requirements to senior management and ensure that the team is properly trained to carry out general responsibilities.

The scope of activities for the team include : cell isolation of multiple cell types from different human organs or tissues, cell culture, sorting and expansion (including cryo-preservation) of multiple cell lines from different human or animal sources, and performing analytical testing.

Essential Job Duties & Responsibilities

• Work with Manufacturing and site leadership to develop objectives for the team and resource requirements to successfully achieve them
• Ensure quality documentation such as deviations and investigations are completed in a timely manner and that root cause is correctly identified
• Serve as a technical expert, train and onboard employees in documentation and process execution
• Build, maintain, and motivate the team to ensure achievement of all productivity targets and output requirements
• Set expectations for employees, conduct regular performance reviews, mentor, coach, and be responsible for managing the cell isolation team in general terms
• Communicate with other departments to ensure alignment of goals and interdependencies
• Maintain ordering information and work with Operations and Procurement teams
• Track expenditures for team projects
• Review team master batch records, documentation, and data entry, and follow up with the team as needed for completion
• Monitor and report progress of biomanufacturing operations projects against timelines
• Implement process improvements designed to gain efficiencies or increase compliance / safety / ease of use
• Ensure that the team meets all compliance, OSHA, and GMP requirements and that work is documented
• Review and edit experimental plans, SOPs, and MBRs, and submit SOPs and MBRs in compliance with Quality standards
• Be responsible for scheduling, process monitoring, and compilation of donor information for analysis
• Communicate to and assist VP Manufacturing on projects and initiatives as required
• Ensure cross-functional alignment and communication (R&D, QA, etc.)
• Ensure supplies are in place for adequate experimental execution
• Maintain equipment and document maintenance activities
• Ensure the manufacturing area adheres to site requirements for compliance and safety

For this role you will need

Minimum Requirements

Bachelor’s Degree in biomedical sciences, cell biology, tissue engineering, or related discipline with 10+ years of relevant industry experience;

or a Master’s Degree in biomedical sciences, cell biology, tissue engineering, or related discipline, with 8+ years of relevant industry experience.

• 2+ years of experience managing and leading teams
• Technical expertise in human cell line cell culture
• Technical expertise in human organ cell isolation
• Exceptional ability to lead, mentor, manage, coach, and motivate team members
• Knowledge of good documentation and good manufacturing practices
• Excellent written and oral communication skills

Preferred Qualifications

Knowledge of kidney and liver biology, physiology, and cell types

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