Job Summary

The Manager, Sterile Fill Manufacturing, is accountable for driving results in a fast-paced environment by providing leadership to the site’s manufacturing function. Focus areas for the role include operational leadership, parenteral (fill/finish, inspection) manufacturing process, project management, continuous improvement, change management, manufacturing investigations/corrective actions, participation in business reviews, and support of regulatory and client audits.

On-Site Expectations

• 100% on-site position.
• 3rd Shift: Sunday - Thursday, 11:00pm - 7:30am.

Responsibilities

• Develops information and produces reports concerning scheduling, production goals, equipment and maintenance problems and other studies or reports as requested.
• Provides manufacturing information by compiling, initiating, sorting, and analyzing production related records and data to key stakeholders within Alcami.
• Ensures all manufacturing discrepancies are captured with appropriate documentation and works collaboratively with appropriate personnel to facilitate client communication per quality agreements.
• Accountable for accurate and timely completion of all department investigation reports and the effective and timely corrective/preventative action (CAPA) implementations and follow-up.
• Accountable for the accurate and timely completion of all manufacturing processes and documentation (batch records) and "first time right" performance goals.
• Responsible for administration of department budget to include forecasting resources for future periods.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
• Other duties as assigned.

Qualifications

• Bachelor’s degree required and a minimum of 8 years of related experience required.
• A minimum of 4 years of supervisory experience is required.
• Prior pharmaceutical experience, CMO or CDMO experience required.
• Aseptic filling experience required.

Knowledge, Skills, and Abilities

• Expert knowledge of review/approving manufacturing investigations ensuring they are completed in a timely manner with appropriate root cause analysis and effective corrective/preventive action identified required.
• Expert Knowledge of supporting the development of new or revised manufacturing instructions preferred.
• Knowledge of operational procedures for equipment preparation, formulation, filing, capping and lyophilization activities within their respective cGMP guidance/procedures required.
• Knowledge of leading manufacturing teams to maintain adherence to a demanding production schedule required.
• Strong computer skills.

Travel Expectations

• Up to 5% 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 required to frequently stand; sit; walk; talk or hear; and reach with hands and arms. The employee is required some of the time to use hands to finger, handle or feel; and climb or balance. The employee is required to occasionally stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 50 pounds. There is no special vision requirement for this job. The employee may frequently work near moving mechanical parts; fumes or airborne particles; and outdoor weather conditions.