Large Molecule Principal Scientist

JOB SUMMARY

The Principal Scientist conducts quantitative and qualitative analysis of protein therapeutic products according to FDA, cGMP and BA Science procedures.    This position will report directly to the Director of Biological Macromolecules, and is responsible for managing the daily execution of client work in the lab including ensuring scheduled and prioritized work is completed to meet customer expectations. The position includes development of analytical methods and attendant procedures, as well as validation of analytical methods, including writing validation protocols and reports.  Techniques will include analysis of pharmaceutical products using LC-MS, HPLC and other appropriate techniques.   

PRIMARY DUTIES AND RESPONSIBILITIES

·        Manage and conduct experiments to ascertain quality attributes for protein therapeutic products, such as amino acid sequence, total protein, and protein structure and modifications.

·        Supervises, trains, and mentors other chemists on an as needed basis.

·        Develop and apply product specific sample preparation and analysis methods for protein/peptide therapeutic products utilizing electrophoresis, chromatography and mass spectrometry or other techniques.

·        Troubleshoot analytical methods.

·        Design, plan and execute assay development, validation and transfer projects.

·        Write validation protocols and validate LC-MS methods according to ICH validation guidelines.

·        Write validation protocols and validate (delete LC-MS) methods according to ICH validation guidelines.

·        Prepare reports and technical data summaries, present and communicate results to collaborators.

·        Provides planning and oversite on projects, establishing the approach, required resources, timing and meeting agreed timelines.

·        Acts as a scientific resource for the department and company as necessary providing guidance.

·        Assists division director as necessary providing updates on projects, system and personel capacity as well as visibility into project timelines.

·        Actively mentor and train analysts on established and emergent techniques as necessary

·        Establishes guideance for Senior scientitsts in the supervison of other members of the group.

·        Produce analyze and interpret analytical data. Perform advanced data generation, analysis and complicated problem solving independently with minimal rework.

·        Ensures all appropriate work is performed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration and United States Pharmacopeia or other compendial methodologies.

REQUIREMENTS & QUALIFICATIONS

Qualifications include a PhD, Master’s or Bachelor’s degree in Biochemistry or a related discipline. Must have laboratory experience with a minimum of 2 years of experience related to protein drug development with a PhD, or 5 years of experience related to protein drug development combined with a Master’s degree, or a minimum of 8 years of related to protein drug development work experience combined with a Bachelor’s degree and 0-2 years in a leadership role.

This position requires a self-starting, motivated person who possesses excellent interpersonal skills and is able to assume a leadership role in the laboratory. The successful candidate will be able to effectively interact and communicate with all departments within the company and client personnel.

Knowledge and understanding of mass spectrometry techniques as related to protein analysis.  Hands on experience with protein analytical method development, particularly in chromatographic methods in combination with mass spectrometry. Knowledge of cGMP’s along with ICH and related compliance regulations and guidance, especially around requirements for analytical method development and validation.

Knowledge of cGMPs along with ICH and related compliance regulations and guidance, especially around requirements for analytical method development and validation.

Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.

MINIMUM SKILLS REQUIREMENTS

·        Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.

·        Must have excellent organizational, verbal communication and technical documentation skills.

·        Solid writing ability and computer skills.

·        Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.

·        Must be a team player with integrity and concern for the quality of Company products, services and staff members. Ability to be an effective hands-on leader.