Director, Drug Product Development at Serán BioScience

Bend, Oregon, United States

Serán BioScience Logo
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries

Requirements

  • B.S. in Science or Engineering discipline with 20+ years experience
  • M.S. in Science or Engineering discipline with 18+ years experience
  • PhD in Science or Engineering discipline with 15+ years experience
  • Demonstrated experience in technical focus areas (formulation sciences, analytical sciences, process engineering, drug product development)
  • Extensive experience developing solid oral dosage forms
  • Hands-on experience with unit operations associated with oral solid dosage forms including dry granulation, wet granulation, encapsulation and compression
  • Experience with formulation development and bench-scale prototyping in addition to scale-up and process scale manufacturing of solid dosage forms
  • Experience with cGMP manufacturing, or minimally the transfer of processes into cGMP manufacturing (preferred)
  • Emphasis on understanding and leveraging material properties throughout formulation and process development
  • Scientific curiosity and willingness to learn
  • Excellent leadership and collaboration skills
  • Demonstrated understanding of pharmaceutical process and/or product development
  • Strong analytical and problem-solving skills
  • Excellent verbal and written communication skills
  • Excellent organizational skills and attention to detail
  • Excellent time management skills with a proven ability to meet deadlines
  • Demonstrated ability to collaborate and lead cross-functional teams
  • Ability to function well in a high-paced and at times stressful environment
  • Ability to prioritize tasks and to delegate them when appropriate
  • Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside of the company
  • Accepts feedback from a variety of sources and constructively manages conflict
  • Proficient with Microsoft Office Suite or related software

Responsibilities

  • Provides strategic vision for organization & group
  • Delegation & oversight of new projects
  • Contributes to defining the technical strategy for new projects
  • Contributes to strategy for the development and implementation of innovative technologies
  • Contributes to company strategy, budgeting and forecasting
  • Interfaces as a technical SME with clients when appropriate
  • Identifies and implements continuous improvements for operational excellence
  • Makes recommendations for capital expenditure to Executive Management
  • Works closely with key stakeholders in the Process and Product Development team and cross-functionally to support tech transfer processes
  • Authors/reviews/approves project proposals and budgets
  • Responsibilities may increase in scope to align with company initiatives
  • Performs other related duties as assigned
  • Leading a team to develop and deliver novel pharmaceutical therapies
  • Responsible for pre-formulation assessments and technology selection
  • Drug product design and formulation development for both the drug product intermediate and drug product
  • Problem statements include both pre-clinical and early phase clinical development of formulations and dosage forms
  • Projects include pharmaceutical final-dosage forms such as tablets, capsules, sachets, suspensions, multi-particulates, pediatric forms and drug product intermediates such as amorphous solid dispersions, micronized or nanoparticle forms, and lipid formulations
  • Primarily focuses on development of formulations for oral delivery
  • Provide technical guidance and support to the team to ensure strategic and efficient work plans and experimental designs with a high standard of scientific excellence in design, execution, analysis and interpretation of experimental work

Skills

Formulation Development
Dry Granulation
Wet Granulation
Encapsulation
Compression
cGMP Manufacturing
Scale-up
Amorphous Solid Dispersions
Nanoparticle Forms
Lipid Formulations
Oral Solid Dosage Forms
Pre-formulation
Bench-scale Prototyping

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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