Minimum BS in Chemistry or science-related field with at least 5-10 years of experience in the pharmaceuticals industry. Managing, coordinating, supervising, and training groups. Providing clear written and verbal instructions to group members and promptly addressing any questions or concerns. Planning daily activities and delegating tasks. Educating and training new group members as well as support staff. Knowledge of all scientific/technical activities within Quality Control lab related to release of drug substance, drug product, stability, In-process, process characterization, equipment cleaning, and method validation as per the regulatory requirement. Analytical knowledge and expertise in the operation & calibration of chromatographic testing using HPLC (Waters & Shimadzu) & GC (water Empower software preferably) along with other instruments like ICPMS, Malvern master sizer, DSC, UV spectrophotometer. Must have the ability to understand and follow written methodologies in accordance with data integrity, good documentation practices, USP, EP, BP, general chapters and cGMP, CFR, ICH guidelines. Extensive knowledge for laboratory investigation procedures to Initiate, Conducts, Investigate, writeup reports related to lab event, Deviations, customer complaint and out-of-specifications. Knowledge of Instrument Qualification for the advance techniques along with troubleshooting capabilities.
- This position has approximately 6-8 direct reports.
- In a team environment, manages subordinates which includes but not limited to assigning work, disciplines, coaching, training to Quality control stability employees.
- Maintains laboratory documentation with details of test procedures, raw data and final results in accordance with regulatory guidelines.
- Performs QC testing for drug substances, products and equipment cleaning samples. If necessary, performs other QC activities such as involved in method transfer.
- Working knowledge in calibration of Laboratory equipment used for chromatographic testing (HPLC/GC) and other laboratory analytical equipment (UV spectrophotometer, pH and conductivity meter, analytical balances, Moisture analyzer, Hardness tester, Friabilator etc.) Maintains advanced knowledge of these techniques and instruments including training and troubleshooting capabilities.
- Performs troubleshooting and initial investigative work related to out-of-specification lab results with input from chemists. Conducts formal investigative procedures and resolving method and instrument problems.
- Writes and reviews analytical documents i.e. Analytical Methods, SOP’s, Protocols and Reports. Organizes workflow within the group to ensure maximum work output and quick response to production priorities.
- Manages routine testing support for QC samples (Dissolution/HPLC/GC/Physical testing), Conducts laboratory disposition of materials (waste/expired chemicals) under cGMP guidelines.
- Ensuring that laboratory documentation complies with regulatory guidelines. Responds to out-of-specification test results in accordance with regulatory guidelines and quickly isolates material issues from testing issues.
- Maintains operations-focused high throughput, quick responsive materials release testing which meet the needs of internal/external customers and Avet business goals.
- Responsible for three Quality Control laboratories including Wet Lab, Dissolution Lab, and HPLC lab.
- All other job-related duties.
Specialized Skills and Knowledge:
- Minimum BS in Chemistry or science related field with 5-10 years of experience in science regulated discipline. Wet chemistry, dissolution, HPLC/GC Chromatography functional-troubleshooting knowledge is preferred.
- Has thorough knowledge of all scientific/technical activities within QC stability with working knowledge and expertise in the fields of gas chromatography, liquid chromatography, wet chemistry, spectroscopic techniques and the regulatory requirement of each in the QC role.
- Ability to operate different types of Chromatographic software related to HPLC/GC. Familiar with Chromatographic software such as Class VP, waters Empower, and EZ Chrome etc. Working knowledge of a variety of laboratory analytical techniques and instruments including many of the following: pH meters, Analytical balances, FT-IR spectrophotometer, DSC, Malvern analyzer, KF titrator, Potentiometer, Polarimeter, etc.
- Understands and uses good quantitative techniques in performing analytical tests and has the math skills to ensure correct calculation of the final result. Has the ability to understand and follow written methodologies in accordance with cGMP standards. Understands and applies USP general chapters.
- Computer skills for operation of laboratory equipment and for data processing/storage along with validation, verification, investigation reports.
- Ability to troubleshoot laboratory techniques/instrumentation, resolve laboratory investigations, distinguishes between laboratory issues and material issues, and resolve material investigations.
- Specialized knowledge of drug manufacturing processes, test disposition processes, and flow of materials.
- Working knowledge and interpretations of cGMP, ICH, FDA guidelines and USP, EP, BP.
- Verbal and written Communication/Job Knowledge
- Planning, Coordination, Initiative and Teamwork
- Ability to work on laboratory investigations initiations like Event, LDN, OOT and RMF
While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Avet is proud to be an Equal Opportunity Employer.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.