Lead Scientist, Analytical QC

TITLE:

Lead Scientist, Analytical QC

Title: Lead Scientist, Analytical QC

Reports To: Principal Scientist, Analytical QC

Location: Raleigh, NC

POSITION SUMMARY:

The QC Analytical Lead Scientist is a key position within the QC team supporting method transfer activities, and performing process improvement initiatives to support the laboratory testing as per USP and ICH guidelines. Method development, verification and validations will be required. This role will report to the Principal Scientist, Analytical QC while working in a collaborative team setting. This role is responsible for supporting and assisting with the delivery of project timelines and critical milestones. This role will be an inward and outward facing role working with contract testing labs as required. This role will also work in a manner that assures quality, safety, efficacy, and compliance to regulatory requirements.

ESSENTIAL FUNCTIONS:

The responsibilities of this role include, but are not limited to, the following:

· Work with Contract Testing Laboratories (CTL) and ensure testing is completed in a timely manner. Participate in resolving technical issues, OOS results and the review/approve testing CoAs.

· Support stability storage and testing in house or at CTL.

· Support the start-up of the QC Laboratory and transition to routine analytical testing, as required.

· Support current and new product technology transfer to the manufacturing site by performing method verifications, validations, and transfers for the QC Laboratory and any additional studies related to Manufacturing.

· Assist in significant OOS investigations, deviations and ensure implementation of appropriate corrective actions.

· Perform and review instrument qualifications, equipment repairs, preventative maintenance calibrations.

· Author, revise, and implement documentation such as standard operation procedures for the QC Laboratory.

· Support the evaluation of test methods and the adaptation of processes and techniques for commercial purposes.

· Independently write and implement study protocols and reports.

· Keep accurate documentation as per current Good Manufacturing Practices (cGMP).

· Experience performing QC analyses with different instruments (wet chemistry, HPLC, GC, KF, FTIR, UV-VIS) is required.

· Perform analyses and peer reviews.

· Any other duties as determined by management to support the QC team.

MINIMUM QUALIFICATIONS:

· Bachelor’s Degree in a Scientific field from an accredited university required.

· Minimum ten (10) years of experience in the pharmaceutical industry required.

· Experience with method validation/verification/transfers required.

· Experience in performing instrument and software qualifications is preferred.

· Experience with USP, CFR, ICH, and ISO regulations and guidelines as well as Quality by Design (QbD) principles is preferred.

· Experience in relevant laboratory, computer, and data analysis skills required.

· NMR experience is preferred but not required.

· Strong organizational abilities and problem-solving skills.

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:

· Working knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma concept.

· Ability to handle a wide variety of tasks under critical time constraints.

· Ability to work independently and in a group setting, collaborative, self-motivated, proactive, and be a critical thinker.

· Ability, at agreed upon times, to work a varied schedule with some potential weekend, early morning, or late evening hours, if required.