- As a member of Analytical Development Method Development team, he/she will work on method development, qualification and characterization of drug substance, drug product and reference standards for biological programs.
- Responsibilities include designing experiments per ICH guidelines, flawless execution of experimental studies, documenting results accurately in the laboratory notebooks, writing and reviewing technical reports, generating test methods to support high throughput and QC testing groups, participate in analytical, process development and QC meetings and discussions, etc.
- Provide quality and regulatory support as needed and actively participate project teams
- Applies technical knowledge under minimal supervision to independently execute method development and assay remediation activities
60% Execution of experimental studies
30% Documentation including writing protocols and reports
10% Training and presenting data
Education and Experience Requirements
BS with 6+ years of industry experience, or MS with 4-6+ years of industry experience in analytical chemistry, biochemistry or other biological/analytical discipline.
Experience in method development, qualification and validation of analytical methods for biologics.
Key skills, Abilities, and Competencies
- Strong analytical and problem solving skills are required
- In-depth knowledge of HPLC, UPLC, LabChip, SoloVPE, and enzyme activity measurements, including both theory and practice is required
- Ability to work successfully in both a team/matrix environment as well as independently
- Ability to work in a fast pace environment, manage priorities, and flexible to work on multiple projects
- Knowledge of cGMPs, regulatory guidelines and good laboratory practice are essential
- Excellent written and verbal communication skills are essential
Complexity and Problem Solving
- Complex problem solving skills
- Understanding of ICH, USP and GMP guidelines
- Flexible to work on multiple projects
Internal and External Contacts
- Internal and external Shire departments
- CROs and CMOs
Other Job Requirements
- Available to participate in early or late meetings/teleconferences
- Familiarity in Microsoft Office (word, excel, and powerpoint) and JMP
Location/Region: Lexington, MA