Senior Formulation Development Scientist
1 week ago
Thermo Fisher Scientific, a world leader in serving science, seeks a highly skilled Senior Formulation Development Scientist to join our Drug Product Division (DPD).
As a key member of our team, you will be responsible for developing and implementing technical solutions that meet client needs and expectations. Your expertise in formulation development will play a critical role in taking sterile injectable, oral solid dose, and softgel drug products from development to commercialization.
About Us
Thermo Fisher Scientific is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. We have over 100,000 colleagues worldwide, delivering an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands.
About the Role
We are seeking a seasoned Senior Formulation Development Scientist to lead technical/scientific process/product/project activities in our Steriles plant. This position requires advanced knowledge of multifaceted aspects or a specialized aspect of a subject area and a solid understanding of principles and concepts in other relevant subject areas. You will work on technical/scientific process/product/project activities to implement strategies and technical solutions that meet client needs and expectations.
Key Responsibilities:
* Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
* May be involved in clinical stage of drug development.
* Works on technical/scientific process/product/project activities to implement strategies and technical solutions that meet client needs and expectations.
* Assists in the creation of processes and equipment design for clinical, scale-up, and/or registration batches, including technology transfer of projects to and from clients.
* Evaluates and contributes to the design of manufacturing processes and supports problem solving as necessary within defined procedures and practices.
* Makes decisions that involve direct application of technical knowledge.
* Design, implement, and evaluate studies, lead tech transfer, commercial scale-up, and support process validation.
* Represent the organization on internal technical discussions.
* Lead and/or participate in problem solving and project work for formulations, equipment, and processes.
* Write/revise work orders for new processes, FORMs, reports, memos, and protocols as required.
* Lead projects with minimal to no supervision, can review and plan all technical aspects of the project to meet appropriate timeline.
* Support manufacturing operations, change controls, investigations as subject matter expert (SME), resolve accurate CAPAs.
* Assess material changes and determine change impact.
* Contribute to development of proposals and timelines for projects, leading relevant client meetings.
* Review new bid quotes, protocols, technical documents, results, and reports.
Requirements
* Bachelor's of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, or related physical science is required.
* 3+ years of experience in a manufacturing environment required.
* Equivalent combinations of education, training, and meaningful work experience may be considered.
* Experience in a CMO or Pharmaceutical product development field PREFERRED.
* Advanced knowledge of multifaceted aspects or a specialized aspect of a subject area and solid understanding of principles and concepts in other relevant subject areas.
* Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
* Detailed knowledge of Good Manufacturing Practices.
* Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
* Excellent critical and logical thinking skills.
* Effective written, interpersonal, and presentation skills, including running technical discussions with internal and external clients.
* Ability to work on multiple projects simultaneously.
* Ability to acquire knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
* Ability to keep current with scientific literature and industry trends relating to process technologies.
* Ability to run technical solutions.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Our estimated salary for this position is $95,000 - $125,000 per year.
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