Manager, Quality Control (Analytical/Commercial Product) – Direct Hire/Top $$
Our client, a high-profile specialty pharmaceutical firm in the RTP area, is actively recruiting for a sharp, knowledgeable and self-directed Analytical Scientist to assume key role on its Quality Control team.
This company is experiencing unprecedented growth. It has multiple commercial products and a rich and growing pipeline. The future is very bright, and it is essential that the company implement Best Practices in its Quality Control function. This Manager will be instrumental in that effort.
Company will pay excellent wage to attract and retain the right candidate.
Key Things to Note:
- The focus of the role will be to manage all analytical activities for commercial products.
- These are small molecule (primarily solid dosage) products and analytical expertise related to small molecule drug product and drug substance will be important.
- The company relies on CDMOs and contract labs for production and testing functions. Right candidate will be accustomed to overseeing the work performed by external partners and very effective at developing positive and productive relationships with these key vendors.
- This is an emerging business in which policy, practices and procedures are still being refined. Seek candidate with the ability to help develop and enhance analytical methods and QC operational execution. Extensive experience with method transfer and validation will be critical.
- This position is on-site at the Raleigh office (hybrid during COVID). Travel is estimated at 15-20% (domestic and international). CDMOs are global.
- Develops strategies for outsourced testing needs, considering timelines, risk mitigation etc., including the oversight of method transfer, qualification/validation and trending across analytical testing sites
- Leads method transfers and implementation of appropriate analytical methods at external laboratories/partners in support of drug substance and drug product.
- Manages contract manufacturers and testing laboratories to communicate and resolve quality control issues
- Analyzes results and methods, solves analytical problems, and meets regulatory expectations for drug substances and drug products
- Leads OOS and other non-conforming investigations and provides technical and compliance risk assessments. Implements appropriate corrective and preventative actions
- Authors and reviews technical and GMP documents (e.g., analytical protocols, SOPs, specifications)
- Prepares portions of CMC documents for regulatory filings (e.g. annual reports and post-approval submissions)
- Actively participates in regulatory authority inspections and inspection readiness efforts
- Performs contract testing lab audits. May partner with Quality Assurance to Audit CMOs
- Provides data-driven recommendations to internal teams regarding analytical activities backed by good science and cGMP principles
Targeted candidate will offer a Scientific Degree (advanced degree desirable) and 6+ years of Quality Control/Analytical experience as applied to small molecule pharmaceuticals. Strong preference for candidates with experience developing and executing analytical methods in a contract testing lab (CTL).
Other priorities include:
- Demonstrated ability to lead projects conducted at third party manufacturers and laboratories, including demonstrated ability to develop quality relationships with vendor partners.
- Firsthand experience with method transfer, qualification and validation
- Strong knowledge of analytical testing techniques applied to small molecule products (e.g. HPLC, dissolution)
- Strong understanding of drug substance and drug product commercial stability requirements
- Ability to manage multiple projects, set priorities, and work in a fast-paced environment
- Some experience working within a global organization.
- Longevity, impact and growth in previous roles
Finally, we seek a candidate who will thrive in a highly dynamic setting. Someone who can switch gears readily, stay focused despite disruption and who can bring enhancements and ideas. The future is very bright, but the present is ever-changing. Seek a contributor who enjoys the challenge and stays focused on the mission.
Please forward Word resume for prompt consideration. Local candidates only.