MANUFACTURING SPECIALIST - Alcami Corporation : Job Details

Job Summary: The Manufacturing Specialist supports cGMP manufacturing of various drug products and troubleshoots unexpected manufacturing events. This includes preparing, conducting, and evaluating continued process verification activities and providing on-going support of commercial and clinical manufacturing. The Manufacturing Specialist works closely with Formulation Development, Manufacturing, QA and Regulatory, EHS and Engineering departments to ensure robust production of cGMP Sterile Drug Products. On-Site Expectations:

• 100% on-site position.

Responsibilities:

• Perform data analysis, including tracking and trending of manufacturing processes to identify areas of improvement.
• Measure and evaluate unit operation durations to implement optimal scheduling to meet facility and client requirements.
• Author protocols and reports needed to support investigations, process changes and equipment modifications.
• Supports the creation and maintenance of cGMP production records and risk assessments.
• Provides training to manufacturing staff on operating procedures, batch records and GMP process rationale.
• Provides technical, on the floor support of commercial, clinical and validated processes.
• Supports clients/stakeholders as a subject matter expert of commercial, clinical and generic products.
• Evaluates product impact of process excursions outside proven acceptable ranges.
• Seeks opportunities to improve process performance within process ranges defined by large-scale equipment capabilities.
• Troubleshoots unexpected events during cGMP manufacturing, assists in investigating and documenting process deviations and CAPAs.
• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.
• Complies with all company and site policies and procedures.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Ensures operations are performed in a safe, clean, and organized work environment free of safety hazards.
• Other duties as assigned.

Qualifications:

• Bachelor's degree required; engineering degree preferred.
• 2 years of experience in regulated cGMP environment.

Knowledge, Skills, and Abilities:

• GMP experience required.
• Must have demonstrated leadership and training skills.

Travel Expectations:

• Up to 10% travel expected.

Physical Demands and Work Environment: The physical demands and work environment 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. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. The noise level is moderate to noisy. Occasionally, the employee may be exposed to airborne particles and fumes or chemicals. Must have the ability to wear PPE as required. The employee occasionally may be exposed to moving mechanical parts and vibration.