Mineralys Therapeutics
More roles at Mineralys TherapeuticsSenior Director, Commercial Supply Chain
Remote role where the employee must remain based in a particular country.
United States only
From the listing details: Residency required in United States
Employer listed it 2 weeks ago · Added 4 weeks ago
Been open since 4 weeks ago, still being checked, but it has been live a while.
Salary
$180,000 to $200,000
Location
United States only
Timezone
Not stated
Contract
Full-time
Experience
Lead
Category
Other
Stated by the employer in the job description
What the advert says
Quoted word for word from the employer's advert. Where it says nothing, we say so.
- Working hours
- Not mentioned in the advert
- Where you can work from
- Location eligibility not confirmed
- Contract
- Not mentioned in the advert
- Experience asked for
- Not mentioned in the advert
- Pay
Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.
Remote flexibility
Work from home
This is a remote role, but the employee must be based in United States. It is work from home rather than work from anywhere.
What the employer says
- Source listing states candidate location: "US Remote, Remote - US"
What Nomaders makes of it
- Residency required in United States
- Payroll and tax are likely handled in that country only
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
Before you apply
Experience: employer states
Written as a requirement
- “A minimum of 15 years’ industry experience in cGMP drug product manufacturing, specifically in the development and manufacturing of small molecule dosage forms; NDA experience required.”
- “Ideal candidate will also have a minimum of 10 years’ industry experience in manufacturing small molecule API according to cGMP regulations.”
Questions worth asking: Nomaders interpretation
- The advert does not say where you can be based. Ask which countries they can legally employ or contract you from.
- The advert does not say whether this is employment or a contractor arrangement. Ask, as it affects tax and benefits.
Produced automatically from this advert's text; not reviewed by a person. The employer's own page is the final word.
About the role
“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com . Follow Mineralys on LinkedIn, Twitter and Bluesky”
Mineralys is a fully remote company.
Position Summary
The Senior Director Commercial Manufacturing will be responsible for providing technical and organizational leadership, project management and oversight of commercial drug product and API manufacturing activities at all contract manufacturers to support scale-up, validation, launch, and continued supply of commercial products and samples needed by the commercial organization.
Key Responsibilities
Head the Commercial Manufacturing function.
Manufactures drug products and API on-time and on-budget to meet forecasted sales volumes.
Participates on the Mineralys Sales and Operations Planning Team to review actual sales/sample distribution and revises drug product and API forecasts accordingly.
Provides forecast updates to all CMOs in accordance with contract requirements.
Provides monthly production and inventory reports from all CMOs to Mineralys Finance for monthly close.
Establishes and oversees commercial manufacturing strategies and operational plans across a portfolio of projects and ensures that they are aligned with the strategic and operational objectives of other functions, and of the company.
Participates in the selection and qualification of third-party suppliers for commercial manufacturing.
Oversees commercial manufacturing operations at third party service providers in a 100% outsourced business model.
Prepares supporting documentation for global regulatory filings and provides technical support for responses to Health Authority comments and inquiries to support commercial marketing applications.
As a subject matter expert (SME) in Drug Product Manufacturing, be a key partner to the Drug Substance, Drug Product, and Analytical Development functions and represent the Commercial Manufacturing function on the CMC Team.
Collaborate with Quality Assurance and Regulatory Affairs to assure compliance with applicable GxP and global regulatory requirements.
Ensure budget, schedules, and performance requirements are met.
May hire, mentor, and develop staff according to the future needs of a growing company.
Education & Experience
• Advanced degree in pharmaceutical sciences, engineering, or related discipline. PhD highly preferred. • A minimum of 15 years’ industry experience in cGMP drug product manufacturing, specifically in the development and manufacturing of small molecule dosage forms; NDA experience required. • Ideal candidate will also have a minimum of 10 years’ industry experience in manufacturing small molecule API according to cGMP regulations. • Strong knowledge of US and EU cGMP requirements, ICH guidelines and best practices relating to drug products and API. • Strong knowledge of formulation development and drug product manufacture across all phases of drug development from initial regulatory filings through registration, scale-up, validation, launch, and commercial supply.
Travel
This position requires up to 50% travel. Frequently travel is outside the local area and overnight.
This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.
US Salary Range: $180,000-$200,000
Requirements
- ·Provides monthly production and inventory reports from all CMOs to Mineralys Finance for monthly close.
- ·Participates in the selection and qualification of third-party suppliers for commercial manufacturing.
- ·Oversees commercial manufacturing operations at third party service providers in a 100% outsourced business model.
- ·Prepares supporting documentation for global regulatory filings and provides technical support for responses to Health Authority comments and inquiries to support commercial marketing applications.
- ·Collaborate with Quality Assurance and Regulatory Affairs to assure compliance with applicable GxP and global regulatory requirements.
Benefits
No benefits package published with this listing. Ask about it at first interview.
How to apply
- 1Check the flexibility label above, work from home, matches where you plan to live and work.
- 2Tailor your CV to the role at Mineralys Therapeutics, mentioning your remote working experience.
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 27d ago. Last checked today. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
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