Position Description: Manager, Manufacturing Operations
Exciting opportunity for experienced Manager of Manufacturing Operations to join the team at Adaptive Phage Therapeutics, Inc (APT). The Manager of Manufacturing Operations will provide day to day oversight of the laboratory staff, including scheduling manufacturing runs and projects, overseeing training, and providing input regarding personnel changes. This position will actively perform and monitor activities in the cGMP manufacturing areas andreports to the Director of Manufacturing.
- Works with Manufacturing Management team and Quality Assurance to ensure the highest level of compliance with cGMP with respect to the storage, use, and documentation activities associated with the manufacture of bulk and finished product.
- Ensures the ongoing validated state of cGMP manufacturing processes as it relates to process performance.
- Actively participates in and coordinates the installation, operation, cleaning, and maintenance of bio-pharmaceutical cGMP equipment.
- Demonstrates, understands, and adheres to APT policies, GMP standards, and safety procedures.
- Ensures personnel are compliant by maintaining current training requirements.
- Coordinates daily tasks with Group Leads and ensures completion.
- Works effectively with manufacturing personnel to build team relationships.
- Establishes and maintains routine management tools and standards to assure that direct reports are utilizing common tools to track resources, time coding, and performance.
- Generates batch records, SOPs, and other controlled documentation as assigned by the Manufacturing Management Team.
- Promotes collaboration with supporting departments to aid in manufacturing initiatives and achieve company goals.
- Actively supports the internal audit program as a means of driving continuous improvement throughout Manufacturing.
- Ensures department compliance with all cGMP regulations as well as other areas of mandatory regulatory oversight.
- Participates in and provides SME resources to support all regulatory audits and technical discussions.
- Identifies and appropriately escalates issues to the Manufacturing Management team to keep operations, projects, and initiatives on schedule.
- Responds to off-hour alarms as assigned by the Manufacturing Management team.
- Real time, on the floor, Batch Production Record review.
- Bachelor’s or Master’s Degree in a scientific/engineering discipline or equivalent related experience in cGMP biologics/pharmaceutical manufacturing
- Minimum of 5- 7 years of cGMP bio-pharmaceutical experience with a minimum of 2 years of supervision/demonstrated leadership
- Knowledge of cGMP and CFR requirements
- Experience in early stage biopharmaceutical manufacturing is a plus
- Experience with bacteriophage is highly desired
- Excellent written and verbal communication skills
- Excellent interpersonal skills including negotiating, influencing, and active listening.
- Fluent with regularly used software applications (MS Word, MS Excel, MS PowerPoint, SharePoint)
Compensation: Salary is industry-standard and is commensurate with experience.
To apply: Please email cover letter and resume to [email protected]
Job ID: 2020-012