UPM Pharmaceuticals · 1 day ago
Manager, QC Drug Product Laboratory
Bristol, TN
Full-time
Onsite
Senior Level
5+ years expUPM Pharmaceuticals is an independent, highly experienced contract development and manufacturing organization located in Bristol, Tennessee. The Manager, QC Drug Product Laboratory provides leadership and oversight for Drug Product release and stability testing, ensures compliance with quality standards, and implements improvements in analytical testing methods.
BiotechnologyHealthcarePharmaceuticalLife ScienceHealth Care
No H1B
Responsibilities
Reviews and determines scheduling priorities and workload allocations for the company’s Drug product testing for the release and stability programs in accordance with protocols and SOPs
Reviews all release and/ or stability reports for accuracy. Monitors trends and investigates stability alerts
Develops stability protocols, ensures proper entry and formatting of data
Initiates Quality Control Notices of Events (QCNOE) to document deviations associated with laboratory testing
Supervises release and/ or stability staff in the performance of their duties
Assists in hiring, performance reviews, and disciplinary actions of the employees under his/her supervision
Ensures laboratory SOPs, cGMPs, and laboratory safety rules are followed at all times
Performs analytical method transfer, optimization, and development/validation design support for analytical methods development/validation of drug substances, drug product, and cleaning residue testing, using guidelines from USP and ICH
Assists with the development of protocols under which the method transfer, optimization, and development are conducted
Assists with the evaluation of validation data and review of the method validation report for submission. Reviews validation reports written by analysts
Writes, edits, and revises test methods and procedures into company SOPs; reviews, writes, or assists in writing SOPs for analytical development
Participates in laboratory investigations and assists in writing investigation reports
Performs US Compendial testing and other testing as required
Documents laboratory activities and files all data using appropriate logbooks, records, files, and equipment calibration logs
Operates laboratory equipment such as balances, pH-meters, hardness testers, and dissolution baths in the performance of required and scheduled test procedures and in accordance with laboratory SOPs
Performs routine sample processing and dosage form analysis using HPLC, dissolution, and UV-Vis analysis equipment
Conducts peer review of other analytical chemist’s and scientist’s work prior to submission to quality assurance
Maintains professional and scientific competence in analytical chemistry by reading scientific literature and/or attending seminars, training sessions, workshops, or classes
Performs other duties as required
Qualification
Required
Bachelor's degree in Chemistry or related scientific field
At least 5 years of analytical chemistry experience
Legally authorized to be employed in the United States
Preferred
Advanced degree
Prior supervisory experience
Pharmaceutical laboratory experience in analytical methods development and validation
Benefits
Employee assistance program
Employee discount
Flexible spending account
Referral program
Relocation assistance
Retirement plan
Company
UPM Pharmaceuticals
UPM Pharmaceuticals is a Bristol Tennessee based contract development and manufacturing organization (CDMO) serving the pharmaceutical and biotechnology industries.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Chris Curtin
Executive vice President and Chief Operations Officer
Company data provided by crunchbase