Sr. Supervisor, Manufacturing Specialist

 

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 Senior Supervisor, Manufacturing Specialist is accountable for driving results in a fast-paced cGMP manufacturing environment by combining elevated Sr. Manufacturing Specialist technical expertise with supervisory leadership of the Manufacturing Specialist function. This role manages Manufacturing Specialists responsible for supporting the Manufacturing team through event reports, root cause investigations, CAPAs, action trackers, change controls, SOPs, procedures, batch record support, process improvement, and technical documentation. The Sr. Supervisor, Manufacturing Specialist ensures the Manufacturing Specialist team serves as the primary technical support organization and subject matter experts for each pharmaceutical filling line, providing compliant, timely, and accurate support for manufacturing execution, documentation, investigations, and continuous improvement. This leader drives performance, prioritization, training, coaching, stakeholder communication, and cross-functional alignment to ensure manufacturing support activities are completed in accordance with Standard Operating Procedures, company policies, and applicable regulatory requirements.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 4:30pm.

Responsibilities

• Performs duties in accordance with Standard Operating Procedures (SOPs), cGMP requirements, company policies, and applicable state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.
• Manages Manufacturing Specialists who support the Manufacturing team through event reports, root cause investigations, CAPAs, action trackers, change controls, technical documentation, SOPs, procedures, and batch record-related support.
• Oversees prioritization, assignment, tracking, and timely completion of Manufacturing-owned investigations, documentation deliverables, action items, change controls, and continuous improvement initiatives.
• Reviews, approves, and oversees Manufacturing documentation, including investigations, CAPAs, change controls, SOPs, procedures, technical documents, batch record improvements, and related compliance deliverables.
• Leads the Manufacturing Specialist team in supporting unexpected event investigations, process deviation documentation, CAPA development, product impact evaluations, and identification of appropriate corrective and preventive actions.
• Provides coaching and technical guidance to Manufacturing Specialists to strengthen investigation quality, root cause analysis, technical writing, GMP documentation, batch record support, and manufacturing process understanding.
• Ensures Manufacturing Specialists serve as line-specific subject matter experts, providing compliant technical support and documentation for filling operations, investigations, process improvements, equipment changes, risk assessments, SOP revisions, and manufacturing execution requirements.
• Develops internal working relationships across Manufacturing, QA, Regulatory, EHS, Engineering, Formulation Development, and other business units to align investigation strategy, documentation expectations, process changes, and manufacturing support priorities.
• Monitors Manufacturing Specialist performance, workload, deliverable status, training progress, timekeeping, time-off coverage, and resource needs to ensure uninterrupted support for Manufacturing operations.
• Provides ongoing coaching, feedback, prioritization, and routine updates to management regarding Manufacturing Specialist performance, deliverable status, compliance risks, escalations, and improvement opportunities.
• Responsible for the selection, training and development, coaching/mentoring, engagement, retention and performance management of a high-performing Manufacturing Specialist team that meets the current and evolving technical support needs of the site.
• Other duties as assigned.

Qualifications

• Bachelor’s degree required.
• 4+ years of relevant Operations experience within the Pharmaceutical Industry
• 2+ years in leadership roles.
• Prior pharmaceutical experience and experience within a FDA regulated industry required.
• Prior CMO or CDMO or manufacturing experience preferred.
• Lean/Six Sigma certification preferred.

Knowledge, Skills, and Abilities

• Knowledge of pharmaceutical manufacturing regulatory requirements and required.
• Knowledge of cGMP, aseptic processing of commercial or clinical parenteral, quality systems, and project management preferred.
• Excellent leadership, detail orientation, written communications and presentation skills required.
• Excellent knowledge of safe handling of chemical/raw materials experience required.

Travel Expectations

• Up to 10% domestic travel required.

Physical Demands and Work Environment

The physical demands 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 stand. The employee is occasionally required to walk; sit 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.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and the risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.