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Job: Manager, Quality Control (Analytical/Commercial Product) – Direct Hire/Top, Frankel Staffing Partners, RTP, NC

General Information

Job title:
Manager, Quality Control (Analytical/Commercial Product) – Direct Hire/Top
Job location:
RTP, NC  27709 United States
Requisition code:
Date posted:
Job category:
Quality Control
Employment type:
Full time

Job Description

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 is a position of impact, and Company will pay excellent wage to attract and retain the right candidate.

This company is experiencing unprecedented growth. It is in the midst of two product launches and boasts a rich and growing pipeline. At this critical time, it is essential that the company implement Best Practices in its Quality Control function. This Manager will be instrumental in that effort.

Key Things to Note:
? The focus of the role will be to manage all analytical activities for commercial products.
? The company relies on CMOs and contract labs for production and testing functions. Right candidate will be accustomed to overseeing the work performed by external partners. Extensive experience with method transfer and validation will be critical.
? The company primarily produces small molecule products. Substantial expertise in analytical testing techniques applied to small molecule pharmaceuticals will be essential.
? 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.
? Travel is estimated at 15-20% (domestic and international.

Selected Responsibilities:

? Develops strategies for outsourced testing needs, considering timelines and schedules, risk mitigation etc. including the oversight of method transfer, qualification/validation, 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
? Supports CMC regulatory submissions for post-approval activities including Annual Reports and testing site transfers
? Supports the Quality Culture through authoring and reviewing technical and GMP documents (e.g., analytical protocols, reports, SOPs, specifications)
? Actively participates in regulatory authority inspections and inspection readiness efforts
? Performs contract testing lab audits. May partner with Quality Assurance to Audit CMOs

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
? 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-pace environment
? 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.

Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at

Job Requirements

(see job description above)
(Job number: 3883653)
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