[Remote] Director CMC Operations at Abarca Health

Boston, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Skills

Key technologies and capabilities for this role

Process DevelopmentBiomanufacturingCell Line DevelopmentRegulatory SubmissionsCRO/CDMO ManagementQuality StandardsRegulatory ComplianceInvestigationsProject ManagementClient AdvisoryBioprocessing Strategies

Questions & Answers

Common questions about this position

What is the location requirement for this role?

The position is onsite in Boston, LLC.

What is the salary for the Director CMC Operations position?

This information is not specified in the job description.

What key skills and experience are required for this role?

Required experience includes process development and biomanufacturing, strong understanding of cell line development, process development, and manufacturing, ability to collaborate with interdisciplinary teams, CRO/CDMO partner management, drafting CMC sections of regulatory submissions, familiarity with global quality standards and regulations (FDA, EMA, Health Canada), and experience in product investigations.

What are Alira Health's company values?

The company's values are to be courageous, be accountable, be honest, be inclusive, and elevate others.

What makes a strong candidate for this Director CMC Operations role?

A strong candidate will have extensive experience in process development, biomanufacturing, cell line development, CRO/CDMO management, regulatory submissions, and global quality standards, along with proven ability to lead interdisciplinary teams and manage consulting staff.

Abarca Health

Pharmacy Benefit Management services provider

About Abarca Health

Abarca Health provides Pharmacy Benefit Management (PBM) services, focusing on flexible and user-friendly solutions for health plans, employers, and government programs like Medicare and Medicaid. Its main product, the Darwin platform, allows clients to quickly implement and modify benefit designs while ensuring compliance with regulations. Abarca Health manages over $5.3 billion in drug spend and processes 100 million prescription claims annually, offering additional services like home delivery for prescriptions. The company's goal is to deliver exceptional service and innovative solutions in the PBM market.

Aventura, FloridaHeadquarters

2005Year Founded

VENTURE_UNKNOWNCompany Stage

HealthcareIndustries

501-1,000Employees

Benefits

PTO

Parental leave

Work flexibility

Health insurance

Wellness stipend

401k

Tuition reimbursement

Leadership development programs

Risks

Increased competition from Amazon Pharmacy and Mark Cuban's Cost Plus Drug Company.

Growing focus on specialty drugs may require platform adaptation.

Shift towards price transparency could pressure Abarca's pricing models.

Differentiation

Abarca Health's Darwin platform is highly adaptable and user-friendly.

The company offers innovative programs like Triple S en Casa for home delivery.

Abarca Health ensures compliance with ever-changing healthcare regulations.

Upsides

Abarca transitioned two million members to Darwin in 18 months, showing operational efficiency.

Collaboration with Blue Shield of California boosts Abarca's reputation in the PBM sector.

Recognition as a top IT workplace attracts top talent, driving innovation.

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