Supervisor of Manufacturing Operations
As our Supervisor of Manufacturing Operations, you will play a crucial role in ensuring the achievement of manufacturing objectives, timelines, and quality standards. You will be responsible for managing and overseeing the manufacturing team to deliver timely, high-quality deliverables to our clients. The position will collaborate with cross-functional teams and will work side-by-side with other professionals to ensure a quality and compliant finish product.
- Oversee the team responsible for the execution of manufacturing operations such as equipment preparation, formulation, filtration, filling, and inspection processes.
- Act as a Subject Matter Expert (SME) concerning various manufacturing processes such as sterilization, formulation, filtration, filling, and inspection providing advice and training to other technicians.
- Maintain and monitor manufacturing records per standards of procedures and Good Documentation Practices (GDP)
- Maintain open lines of communication with the entire manufacturing team and foster a culture of continuous improvement.
- Champion, teach and monitor safe work practices per standards of procedures and external requirements.
- Assist routine maintenance on manufacturing equipment
- Assist in maintaining a sterile environment that adheres to industry regulations
- Lead initiatives of integration and automation of processes to ensure the integrity of manufacturing data into electronic systems.
- Perform root cause identification activities, deviations, change controls, corrective, and preventive actions (CAPA).
- Identify and lead improvements opportunities to enhance LEAN culture and infrastructure.
- Track, review, and report the project progress to achieve operational goals and metrics.
- B.S. degree in Pharmaceutical or Life Sciences (Biology, Chemistry or Engineering)
- Ten years or more of related experience, or equivalent education, experience, and training
- Proficiency in aseptic processing and manufacturing operations using filling machines, filtration equipment, autoclaves, and semi-automatic inspection machines
- Experience in a cGMP environment is required
- Knowledge of USP, Ph. Eur., FDA, and ICH requirements as they apply to the production of drug substances and drug products is preferred
- Candidate must possess the ability to develop and optimize processes, procedures, and the agility to change directions when required
- Ability to influence employees to ensure completion of pre-established due dates
- Ability to find a solution for or to deal proactively with work-related problems; ability to look beyond the standard solutions
- Experience with inspections/audits by regulatory agencies and clients is preferred
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.