As our Chemist, you will be responsible for providing technical and scientific support in developing, validating and executing various testing. You will collaborate with cross-functional teams and will work side-by-side with other scientists and professionals to drive the scientific agenda.
- Take a central role in the development, validation, and testing of small molecules in pharmaceutical products.
- Assist in the onboarding of state-of-the-art technologies and instrumentation.
- Write and review method validation protocols, reports, SOPs, investigations, test methods, and specifications.
- Coordinate progress of root cause identification, deviations, change controls, corrective, and preventive actions (CAPA).
- Lead commissioning activities and set up safety programs for the laboratory space.
- Lead the initiative of integration and automation of processes to ensure the integrity of laboratory data.
- Act as a Subject Matter Expert (SME) concerning various laboratory software usages (Empower3, ProCal, Master Control, ELN, etc.).
- Lead the development of testing templates in the Laboratory Information Management System.
- Ensure all equipment is calibrated correctly and serviced to support high throughput and full compliance.
- Assist in designing, monitoring, and testing programs and strategically evaluates processes for improvements and optimization.
- Identify and lead improvements opportunities to enhance LEAN culture and infrastructure.
- Track and review the project progress to achieve operational goals and metrics.
- Develop team members through adequate training, mentoring, and motivation, as well as adherence to quality performance standards.
- Actively participate in cGMP inspections, client visits, and regulatory audits.
- Perform additional duties as required.
- B.S. in Chemistry or Pharmaceutical Sciences with six years related experience, or equivalent education, experience, and training; Master’s degree with four years similar experience; Doctorate Degree with two years relevant experience knowledge
- Proficiency in small molecule testing using HPLC/UPLC, GC, particle size analyzer, dissolution, wet chemistry, and other testing methods in a cGMP environment
- Knowledge of USP, Ph. Eur., FDA, and ICH requirements as they apply to the production and testing of drug substances and drug products is a must
- Experience with inspections/audits by regulatory agencies and clients
TriPharm Services, Inc. is an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. TriPharm complies with all employment eligibility verification requirements of the Immigration and Nationality Act, and all must have the authorization to work in the U.S.