Manager, Upstream Dry Powder Inhalation

at  United Therapeutics

California, US residents
click here
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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

United Therapeutics supplies Dry Powder Inhalation (DPI) medicines from the RTP, NC facility across a 24/7 shift structure. The Manager, Upstream DPI is responsible for leading multiple skilled manufacturing teams across the formulation, spray drying, blending, filling and packaging commercial operations. With strong leadership skills and a focus on ensuring strict adherence to safety, quality and regulatory standards, this role drives continuous improvement with a passion. This individual will also use expertise and experience in leading operational teams that supply complex regulated products.

• Provide strong leadership to the upstream DPI manufacturing team, fostering a culture of collaboration, accountability, and continuous improvement across all shifts that support the 24/7 operation
• Deliver product against a balanced scorecard, ensuring that that all safety and quality/compliance standards are met to support the supply of medicines on time and within budget
• Review/approve current SOPs/batch records and assist in writing new SOPs/batch records and protocols. Assist supervisor in training associates as necessary.
• Effectively communicate production needs and/or issues with senior leadership
• Collaborate with leaders in other departments (e.g. warehouse, quality, maintenance, engineering) to effectively resolve manufacturing constraints (e.g. material flow issues, equipment performance challenges)
• Assist supervisor in the scheduling of upstream manufacturing personnel
• Ensure that safety issues and quality deviations are fully investigated and documented, and CAPAs are implemented to mitigate risk of repeat incidents
• Assist in driving continuous improvement initiatives, including the implementation of new technologies and process optimization
• Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, and career development, and support the recruitment and retention of a diverse workforce
• Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary

For this role you will need

Minimum Requirements

• Associate’s degree in a scientific discipline or a related field
• 10+ years of experience in cGMP manufacturing environment with an Associate’s Degree or
• 8+ years of experience in cGMP manufacturing environment with a Bachelor’s Degree
• 3+ years of people management experience
• Must have a current, valid Passport
• Strong leadership skills, a focus on ensuring strict adherence to safety, quality and regulatory standards, and a passion to drive continuous improvement
• Expertise and experience in leading operational teams that supply complex regulated products (preferably dry powder inhalers)
• Must possess excellent written and oral communication skills
• Ability to apply GMP to company specific processes and products
• Ability to objectively, accurately, and thoroughly convey complex issues in writing; ability to produce a large volume of written materials independently
• Ability to interact with other departments effectively
• Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures as they relate to manufacturing requirements
• Ability to handle confidential company data, information, etc.
• Microsoft Office or equivalent
• Ability to respond to escalated concerns to support off-shift operations as needed

Preferred Qualifications

• Bachelor’s Degree in a scientific discipline or a related field
• 6+ years of experience in cGMP pharmaceutical manufacturing environment
• 5+ years of people management experience
• Knowledge of complex products and processes in a drug manufacturing facility
• Knowledge of spray drying related to drug manufacturing
• Knowledge of dry powder fill/pack operations in a drug manufacturing facility

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.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit
https://www.unither.com/careers/benefits-and-amenities
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

• Provide strong leadership to the upstream DPI manufacturing team, fostering a culture of collaboration, accountability, and continuous improvement across all shifts that support the 24/7 operation
• Deliver product against a balanced scorecard, ensuring that that all safety and quality/compliance standards are met to support the supply of medicines on time and within budget
• Review/approve current SOPs/batch records and assist in writing new SOPs/batch records and protocols. Assist supervisor in training associates as necessary.
• Effectively communicate production needs and/or issues with senior leadership
• Collaborate with leaders in other departments (e.g. warehouse, quality, maintenance, engineering) to effectively resolve manufacturing constraints (e.g. material flow issues, equipment performance challenges)
• Assist supervisor in the scheduling of upstream manufacturing personnel
• Ensure that safety issues and quality deviations are fully investigated and documented, and CAPAs are implemented to mitigate risk of repeat incidents
• Assist in driving continuous improvement initiatives, including the implementation of new technologies and process optimization
• Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, and career development, and support the recruitment and retention of a diverse workforce
• Duties and responsibilities are not limited to the work listed above and may include other assignments as necessar