Manufacturing Technician II
As Manufacturing Technician II, you will play a key role in ensuring the execution of formulation, equipment preparation, filling, and inspection processes at our manufacturing headquarters. This position will collaborate with cross-functional teams to provide a quality and compliant finished product.
- Develop analytical technology strategy with input from internal experts and participation in external networks.
- Accountable for all analytical activities supporting new product introduction (NPI) and global support for commercial products.
- Oversee analytical method improvements and new technology implementation
- Support new business opportunities, providing due diligence and direct technical support as needed Ensure compliance with internal standards and policies related to analytical operations.
- Develop collaborative and productive working relationships with CMOs, critical external vendors and suppliers.
- Oversee stability study programs and the review and verification of data and reporting
- Oversee appropriate analytical method qualification, method validation, method transfer, and change control activities.
- Recruit, develop, and mentor the analytical team to meet current and future programs, departments, and individual goals.
- Champion ownership through excellent cost-center management.
- Drive innovative approaches to the development, evaluation, and negotiation with regulatory agencies of analytical control strategies including specifications and stability.
- B.S. or A.S. in Pharmaceutical or Life Sciences (Biology, Chemistry, or Engineering) with two years related experience
- Knowledge in aseptic processing and manufacturing operations using filling machines, filtration equipment, autoclaves, and semi-automatic inspection machines
- Experience in a cGMP environment
- Preferred but not required: knowledge of USP, Ph. Eur., FDA, and ICH requirements as they apply to the production of drug substances and drug products, 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.