Consultant, Biologics Analytical Development and Quality Control
1000 Winter St North Building, Suite 1200 Waltham, MA 02451 US
Location: 100% REMOTE; Ideally PST so that it's easier to join meetings with China. Half of Analytical Development is in CA.
The Consultant for Biologics Analytical Development and Quality Control will provide operational support for analytical development and quality control activities. S/he will manage the outsourced analytical development and quality control testing activities and work proactively with internal and external partners to ensure successful delivery with regard to technical quality and timelines. Works within a cross-functional development team environment to support Zenas’ senior leadership team in defining and executing against short-, intermediate- and long-term strategic goals.
- Provides technical management, and oversight for:
- Analytical activities performed at CDMOs/CROs associated with method development, qualification and validation, in-process testing, release and characterization testing of cell banks, drug substance, drug product and reference standard qualification.
- Methods transfer activities to and from CDMOs and CROs, coordinate qualification and validation activities to ensure the timelines and deliverables.
- Stability programs conducted at CDMOs/CROs including stability study design, study initiation, sample pull/testing and stability data assessment.
- Reviews data generated from CDMOs/CROs including method qualification/validation, lot release and stability testing.
- Generates internal quality control related documentation (specifications, COAs, expiry forms).
- In partnership with QA and CDMOs/CROs, supports deviation and OOS/ OOT investigations, and associated CAPAs for product release, stability testing, and temperature excursions.
- Assist internal preparation for CMC updates in regulatory filings with data integrity review and verification.
- Ensures well-organized, clear, and complete records of all activities across areas of responsibility.
- MS in chemistry, biochemistry, or biochemical/bioprocess engineering (or other relevant physical or life sciences discipline) or BS with equivalent education or experience is required.
- 8-10 years of experience in biologics drug development in biotech or biopharma industry, with significant hands-on experience in areas of analytical development and quality control.
- Experience in managing biologics analytical method development, qualification, validation, transfer, and product release and stability testing activities in an outsourcing model.
- Effective self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment.
- Demonstrated ability to work efficiently across multiple global project teams, business functions.
- Excellent written and verbal communication.
- Ability to work effectively from a virtual home office setting.
- Ability to work non-traditional work hours when needed, given international operations across time zones.
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