The Quality Control, Lead supports the Quality Control (QC) department in the planning, execution and management of in-house and outsourced (Contract Test Laboratories - CTLs) QC and Stability activities. The individual will assist in managing quality events such as deviations and investigations, as well as change controls. The candidate is also responsible for preparation and review of the CMC section of regulatory submission. This role will supervise direct reports. Strong organizational skills are required, as well as the ability to balance changing priorities.
Primary Responsibilities Include:
Review of Drug Substance and Drug Product release and stability data and certificates of analysis received from CTLs.
Manage stability data trending and product shelf life/retest period.
Assist in writing and reviewing technical protocols and reports.
Develop and deploy internal and CTL SOPs.
Assist in writing validation protocols, reviewing validation reports for analytical methods. Provide guidance and technical input for method validations/qualifications.
Manage quality events, such as deviations, OOS/OOT investigations, change controls and CAPAs.
Assist in managing the work flow and priorities at the CTL sites.
Assist in transferring assays to vendor sites and managing life cycle of those documents.
Support CMC regulatory functions.
Supervise direct report(s).
Education and Skills Requirement:
Bachelor's Degree or Master's Degree in life sciences.
5-8 years' experience in a direct laboratory setting and analyzing samples.
Demonstrable experience in method development and method validation for Oligonucleotide analysis methods.
Managing 2-3 QC associates would be considered desirable but not necessary.
Solid understanding of cGMP requirements. Experience in working in a cGMP environment is highly desired.
Proven ability to work independently and effectively handle multiple priorities is a must.
Ability to maintain confidentiality of proprietary information expected.
A good team player that takes initiative to complete tasks diligently and correctly.
Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within an organization.
Proficient written and verbal communication skills.
Position may require some travel.
Experience with Contract Test Laboratories a plus.