- Perform testing of samples as per established test methods and interprets and reports the results to internal and external stakeholders
- Documents data accurately and completely as per established company guidelines and SOPs
- Authors technical documents such as reports, protocols, and internal/external presentations
- Applies technical knowledge under minimal supervision to independently execute method development and remediation for the elucidation and monitoring of the safety profiles of protein therapeutics specifically the quantitation of process-related impurities
- Contributes as part of a small team of scientists to drive the strategy for method development, optimization, qualification and technical transfer of analytical methods to be used in support of biological therapeutic product release and characterization testing in a compliance-based environment in a timely manner to meet program and company timelines
- Provide quality and regulatory support as needed and actively participate project teams
- Method development/remediation (40% of time)
- Execution of existing test methods (20% of time)
- Documentation, data verification, authorship of reports/presentations (20% of time)
- General lab upkeep (20% of time)
EDUCATION & EXPERIENCE REQUIREMENTS
Candidate must have a degree in Chemistry, Biochemistry or other biological/analytical discipline
Candidate must have the following experience in biotechnology, pharmaceutical, or related environment :
BS with 6+ years of industry experience, or
MS with 4-6+ years of industry experience
Experience in analytical methods such as ELISA and qPCR required.
KEY SKILLS, ABILITIES & COMPETENCIES
- Strong computer, scientific & organizational skills
- Excellent communication (oral and written) and attention to detail
- Ability to be approachable, self-motivated, adaptable and manage setbacks with a positive attitude
- Ability to work independently and as part of a collaborative team
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
- Understands and applies advanced scientific principles, theories, concepts, practices and standards to process and product development.
- Demonstrated experience working with plate based immunological and molecular biology methods. Experience with one or more of following methods: ELISA, MSD, Octet protein binding assays, Host Cell Protein assays, picogreen and qPCR.
- Strong working knowledge of current industry standards and USP Chapters for method development, qualification and technical transfer
COMPLEXITY & PROBLEM SOLVING
Will be able to work independently with minimal supervision. Reviews work for technical soundness and accuracy. Exercises judgement in resolving problems in which initiative and judgement are required. Makes recommendations to management in decision making.
INTERNAL & EXTERNAL CONTACTS
Contacts primarily with other professionals within the group. Collaborations may involve others across the department and organization
Location/Region: Lexington, MA