Manufacturing Specialist – Aseptic

 

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

 

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Job Summary

The Manufacturing Specialist - Aseptic supports cGMP manufacturing and troubleshoots unexpected manufacturing events, 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 to ensure robust production of cGMP Sterile Drug Products. The position requires good leadership behaviors and ability to train others.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 7:00am - 3:30pm.

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 Change Controls to support investigations, process changes and equipment modifications.
• Author investigations and facilitate the closure of investigations on time.
• Review and approve new batch records as well as perform review of executed batch records.
• 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 other departments 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

• Related bachelor’s degree preferred with 2+ years related experience in the manufacture of sterile injectable products in a regulated environment.
• Or applicants with high school or equivalent certification with 8+ years related experience in the manufacture of sterile injectable products in a regulated environment.
• Must have at least 1 year of experience in technical writing (deviations, SOPs, batch records, etc.).
• Must have demonstrated leadership and training experience.

Knowledge, Skills, and Abilities

• Ability to drive manufacturing operations and identify/improve inefficiencies.
• Ability to work with people at all levels of the organization.
• Ability to create and interpret graphs and charts.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Ability to write reports, business correspondence and procedure manuals.
• Ability to read, analyze and interpret general business periodicals, professional journals technical procedures and governmental regulations.
• Ability to effectively present information and respond to questions from groups of managers and clients.
• Basic knowledge of computers and Microsoft Office software products.
• Applies job skills, company policies and SOPs to complete a variety of tasks.
• Receives general instructions on routine work, detailed instructions on new projects or assignments.

Travel Expectations

• Up to 5% travel required.

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, employee may be exposed to airborne particles and fumes. Occasionally, employee may be exposed to chemicals. Must have the ability to wear PPE as required. Employee occasionally may be exposed to moving mechanical parts and vibration.