Manager, Sterile Fill Manufacturing - 2nd Shift

Alcami Corporation • North Charleston, SC

9d • Onsite

About The Position

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.
Are you interested in joining our team?
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.
2nd Shift: Monday - Friday, 3:00pm - 11:30pm

Requirements

• 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.
• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees