Planet Pharma · 13 hours ago
Analytical Sciences Quality Lead
New Haven, CT
Contract
Onsite
Senior Level, Lead/Staff
8+ years expPlanet Pharma is seeking an Analytical Sciences Quality Lead to provide quality partnership and oversight to the Product Development Clinical Supply at the New Haven site and external partners. The role involves ensuring quality oversight of testing, stability, analytical technical transfers, and quality systems in a matrix environment.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Michael Sullivan
Responsibilities
Review of technical documents, analytical method validation and transfers for Phase I to III clinical products (including but not limited to biologics, synthetics, cell & gene therapy as well as combination products)
Quality oversight of assay validation and transfer programs internally and externally
Review and approval of stability reports, analytical development, equipment qualification reports and verification reports
Perform data verification on CMC sections for filings based on technical reports
Partner with ADQC and PDCS Compliance team to manage the timely completion of QMS records (Change Controls, Deviations, LIRs and CAPA’s) aligned to Global quality metrics goals
Proactively manage clinical product quality risks ensuring they are appropriately mitigated, actioned and escalated to senior management as required
Supports analytical lifecycle management initiatives
Partner with other Quality colleagues on product quality impact assessments, particularly for notifications to management, recalls, etc
Qualification
Required
8 years or more cGMP experience within quality assurance in a biotech, pharmaceutical, or biopharmaceutical manufacturing environment, clinical phases through commercial
Prior experience with method validation and method transfers
Strong analytical background
Demonstrated ability in decision making, problem solving and project management
Collaborate, negotiate, influence and lead in a matrix organization
Excellent communication and interpersonal skills
Knowledge of quality systems with a strong technical acumen required
B.Sc./MS degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase