Drug Product Manager, Manufacturing

Role Summary

The Drug Product Manager, Manufacturing, is responsible for organizing, managing, and continuously improving the manufacturing operations and process at a manufacturing site.

Responsibilities

• Leads a team of Manufacturing Associates whose direct responsibilities include producing product on the manufacturing floor.
• First line of contact to handle process and equipment deviations on the floor. Areas of responsibility could include upstream (cell culture), downstream (Purification), and/or fill/finish activities as well as media and buffers.
• Produces clinical and commercial material on an annual basis that meets the site‚Äôs strategic objects and is compliant with cGMPs and safety regulations.
• Accountable for performance in their area
• Sets vision, strategy and goals for their area.
• Accountable to have leader standard work for Supervisors and ensure activities are manageable within normal scheduled work hours.
• Proactively identifies risks to achieving goals and mitigates them.
• Creates environment where org can successfully achieve their goals, equally on all shifts.
• Partners with support groups to address issues safely, compliantly and effectively.
• Ensures documentation (batch records and SOPs) are accurate and updated as required.
• Participates in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.
• Provides monthly manufacturing metrics as determined by management.
• Leads areas of tech transfer of new products and processes into the manufacturing area. Provide manufacturing feedback on engineering related projects.
• Identifies and implements continuous improvement opportunities.
• Leads and mentors staff. Write performance reviews and annual goals, hold one-on-ones, and handle HR related matters.
• Other related duties as assigned.

Qualifications

• B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
• Prior management experience.
• 5 years of experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification (TFF, chromatography), aseptic fill/finish with:
• Solid knowledge of FDA regulations and GMP systems
• Excellent oral and written communication skills.
• Strong technical writing ability.
• Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.
• Demonstrated leadership skills.
• Experience in strategic/tactical planning, team building, and meeting budgets.

Skills

• Leadership and people management
• Process improvement and continuous improvement methodologies
• Technical writing and clear communication
• Technical knowledge of biopharmaceutical manufacturing processes
• Project planning and execution