Principal Scientist (Process Definition and Scale-Up) at Serán BioScience

Bend, Oregon, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

B.S. in Science or Engineering discipline with 10+ years of experience, or M.S. in Science or Engineering discipline with 8+ years of experience, or Ph.D. in Science or Engineering discipline with 3+ years of experience (combination of degree and experience required, including 3+ years on projects with GMP execution deliverables)
Demonstrated experience with pharmaceutical product and process development, focusing on oral solid dosage forms
Expertise with common unit operations for blending, milling, granulation, compression, fluid bed coating, and encapsulation
Understanding of formulation concepts and material properties of common excipients
Demonstrated experience in process development activities supporting process validation, with familiarity of regulatory expectations and industry practices
Demonstrated experience with transfer of manufacturing processes into GMP environments and/or between manufacturing sites
Demonstrated experience with principles of risk-based decision making and common tools for risk analysis
Ability to apply rigorous scientific and engineering principles to guide practical decisions
Advanced laboratory and data analysis skills
Excellent verbal and written communication skills
Excellent time management skills, with ability to prioritize and/or delegate tasks to meet deadlines
Excellent leadership and collaboration skills
Ability to function well in a high-paced and stressful environment
Adheres to consistent and predictable in-person attendance
Prolonged periods of sitting or standing at a desk and working on a computer
Must be able to lift up to 25 pounds regularly
Motor skills required for basic laboratory operations (pouring liquids)

Responsibilities

Achieves results with a high level of independence and uses judgement to solicit guidance
Leads technical aspects of projects, and may act as a subject matter expert to provide support and guidance for other projects
Develops broader technical strategy and specific experimental work plans
Performs and/or supervises experimental execution as appropriate to ensure quality of results
Analyzes data, draws conclusions, and proposes next steps to meet project milestones
Authors and reviews technical reports and presentations
Interfaces with clients through verbal and written communications
Effectively communicates with internal stakeholders to manage project timelines and strategy
Adapts approach to evolving project requirements
Mentors, and may manage employees
Coordinates the work of other team members
Provides technical guidance and mentorship
May have direct reports and provide constructive and timely performance evaluations
Responsibilities may increase in scope to align with company initiatives
Performs related duties as assigned

Skills

Key technologies and capabilities for this role

Process DevelopmentScale-UpProcess ValidationPharmaceutical ManufacturingOral Solid DosageData AnalysisTechnical WritingClient CommunicationMentoringTeam LeadershipExperimental DesignRisk-Based Decision Making

Questions & Answers

Common questions about this position

What is the salary for the Principal Scientist position?

This information is not specified in the job description.

Is this a remote position, or is there a required location?

This information is not specified in the job description.

What key skills are required for this Principal Scientist role?

Required skills include demonstrated experience with pharmaceutical product and process development focused on oral solid dosage forms, expertise with unit operations like blending, milling, granulation, compression, fluid bed coating, and encapsulation, understanding of formulation concepts and excipient properties, experience in process validation and GMP transfers, and risk-based decision making.

What does the team structure look like for this role?

The role involves mentoring and training team members, coordinating the work of other team members, providing technical guidance, and may include direct reports with performance evaluations.

What makes a strong candidate for this Principal Scientist position?

A strong candidate blends strong fundamental knowledge with practical, risk-based decision making, has hands-on experimental experience in oral solid dosage process development, and can lead projects independently while mentoring others.

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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