Validation Engineer, Commercial Operations at Serán BioScience

Bend, Oregon, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Skills

Key technologies and capabilities for this role

cGMPFDACommissioningQualificationProcess ValidationCleaning ValidationComputerized Systems ValidationTech TransferManufacturing Processes

Questions & Answers

Common questions about this position

What is the work location for this Validation Engineer position?

The position is onsite.

What is the salary for this role?

This information is not specified in the job description.

What key skills are required for the Validation Engineer role?

Required skills include thorough understanding of cGMPs, FDA requirements, excellent communication skills, ability to collaborate cross-functionally, and technical knowledge of manufacturing processes and systems.

What is the team structure like for this position?

The role involves working as part of a cross-functional team under the supervision of Commercial Leadership, collaborating with internal and external teams.

What makes a strong candidate for this Validation Engineer position?

Strong candidates have pharmaceutical industry experience, acquired knowledge of cGMPs through education and training, and understanding of global regulatory requirements, along with the listed core skills.

Serán BioScience

Contract development and manufacturing for pharmaceuticals

About Serán BioScience

Serán BioScience specializes in providing drug development and manufacturing services as a Contract Development and Manufacturing Organization (CDMO). They offer a variety of services, including preformulation, formulation development, dosage form development, spray drying, and particle engineering. Their operations adhere to current Good Manufacturing Practice (cGMP) standards, ensuring high quality and safety in their products through rigorous analytical quality control. Serán BioScience serves a wide range of clients, from small biotech startups to large pharmaceutical companies, and is distinguished by its flexibility in tailoring services to meet specific client needs. The company's goal is to enhance the efficiency and effectiveness of drug development processes for their clients.

Bend, OregonHeadquarters

2016Year Founded

$194.5MTotal Funding

GROWTH_EQUITY_VCCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Paid Vacation

401(k) Retirement Plan

Health Insurance

Life Insurance

Disability Insurance

Mental Health Support

Pet Insurance

Risks

Emerging CDMOs in Asia offer lower-cost services, impacting Serán's market share.

Potential delays in new facility construction could affect expansion plans.

Global talent shortage may hinder recruitment for Serán's expansion.

Differentiation

Serán specializes in advanced drug formulation techniques, including spray drying and particle engineering.

The company offers cGMP manufacturing and analytical quality control services.

Serán's flexibility allows tailored services to meet specific client needs.

Upsides

Serán announced a $200 million strategic growth transaction for expansion.

The company plans to build a new commercial-scale manufacturing facility.

Increased demand for personalized medicine aligns with Serán's formulation expertise.

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