Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

How will you make an impact?

• Technically supports day-to-day operations in the Formulation, Filling, and/or freeze-drying areas of the Steriles plant.
• Investigates create and validate scientific methodologies used to control raw materials, production intermediates, and final products in a complex scope of processes, products, and projects.
• May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development.
• Works on technical/scientific process/product/project activities to execute strategies and technical solutions that meet client needs and expectations.
• Participates in technical discussions with clients with a high level of technical proficiency.
• Engages in creating 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 with independent judgment. Makes decisions that require developing new options to solve complex problems.

• Participates in the development of scientific strategy.
• Develops realistic proposals and timelines.
• Leads meetings/teleconferences with clients.
• Coordinates development of methods and processes that meet or exceed clients' expectations and provide innovation as necessary.
• Coordinates research of industry practices and processes and applies to innovative drug development internally and for client products.
• Presents recommendations internally and to clients.
• Leads projects without supervision; may lead multiple projects, including managing project timelines and deliverables.
• Guides and advises during the implementation of new methodologies and processes.
• Solves problems related to the conduct of chemical experiments.
• Liaises with internal scientific, analytical, and laboratory functional areas to meet project and team objectives.
• Performs all duties strictly following Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
• Maintains the necessary compliance status required by company and facility standards.

• Bachelor's of Science in Chemistry, Biochemistry, Biology, or related physical science. Advanced degree preferred.

• Prefer 8 years of progressive scientific experience, including 5 years in a related life sciences field.
• Or a master's degree typically requires 6 years of related experience, while a related PhD typically requires 3 years of experience.
• If No degree requires 10 years of related experience.
• Experience working directly with clients.

• Advanced knowledge of varied or specialized aspects of a discipline and working knowledge of principles and concepts in other relevant disciplines.
• Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
• Thorough knowledge of Good Manufacturing Practices.
• Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills.
• Practical written, interpersonal, and presentation skills, including managing technical discussions with internal and external clients.
• Ability to work on multiple projects simultaneously.
• Ability to develop 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 develop technical solutions.
• The position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations, stand and walk, and lift and/or carry light objects of up to 25 lbs. for brief periods.