Principal Scientist I - Analytical Testing

 

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

 

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Job Summary

The Principal Scientist I demonstrates in depth working knowledge of scientific principles (e.g. LC, GC, Dissolution, MS, etc.) and leads the implementation of new methods/processes to solve problems in a fast-paced environment. This role prepares and reviews summaries of observations and is capable of verbal and written presentations documented proficiently in laboratory notebooks to internal and external audiences. The incumbent will write and review SOPs, training modules, summary reports and technical reports to be sent to clients or used in regulatory filings and is responsible for ensuring complex technical information is well understood by team associates, management, and clients. The position help secure new business supporting BD in technical discussions with potential clients. The Principal Scientist I determines appropriate methods and procedures for new assignments.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Uses advanced skills in multiple techniques: assay/impurities, dissolution/drug release, residual solvents, elemental impurities, moisture content, identification and various other wet chemistry-based measurements.
• Supports analytical studies for several modalities, which may include peptides, proteins, carbohydrates, nucleic acids as well as small molecule drugs in solid dosage forms, parenteral, transdermal patches, liquids, and APIs.
• Interprets and communicates analytical data.
• Maintains an expert knowledge and mastery of instrumentation, procedures, and scientific methodologies necessary to perform complex projects.
• Provides problem solving and technical trouble-shooting assistance applying state-of-the-art scientific principles and innovative, efficient use of instrumentation and equipment. Performs routine analytical procedures necessary for support of development activities.
• Writes project documentation, which includes developmental and validation reports.
• Establishes and coordinates activities at contract chemical and analytical laboratories, as required.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Effectively uses various laboratory software packages (Empower3, ProCal, Master Control, NuGenesis, etc.).
• Participates in scientific conferences and contributes to scientific journals. Writes client communications, deviations, and investigations. Positively interacts with clients and participates in FDA and/or client audits.
• Effective in securing new business supporting BD in technical discussions with potential clients.
• Leads and mentors other scientists.
• Other duties as assigned.

Qualifications

• BS or BA in Chemistry or related field required with minimum of 15 years’ experience; OR
• Master’s degree in Chemistry or related field with a minimum of 11 years’ experience; OR
• Doctoral degree with a minimum of 10 years’ experience.

Knowledge, Skills, and Abilities

• Knowledge in handling, analyzing and characterizing chemicals, pharmaceuticals, and related organic molecules.
• Requires minimal hands-on experience in analytical techniques such as LC, GC, etc.
• Ability to apply scientific principles, theories and concepts to research problems and develop solutions for analytical problems in compliance with appropriate Standard Operating Procedures (SOPs) and regulatory guidelines.
• Demonstrates technical ability to assist in the design and execution of non-routine experiments.
• Ability to correctly analyze data/results and interpret outcome of experiments and to propose appropriate follow-up.
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, and governmental regulations and write reports, business correspondence and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to perform complex math functions, compute ratios, rates and percentages while drawing and interpreting graphs and charts.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
• Working knowledge of Microsoft Office Software.

Travel Expectations

• Up to 5% travel required.