Technician ll, Drug Product Manufacturing (5146)
About The Position
This is a full-time position, reporting to the Manufacturing Head of DP12. The Engineer of Drug Product Manufacturing will be a key member of the Manufacturing team and will work independently and in a team to contribute to the qualification, operation and overall success of the clinical drug product manufacturing facility. This includes but is not limited to supervising a team of technicians responsible for the manufacturing support activities in drug product manufacturing, such as buffer preparation, visual inspection of finished product, and other tasks as assigned. Responsible for providing direct oversight, coaching, mentoring and leadership in the drug product manufacturing activities according to current Good Manufacturing Practices (cGMPs).
Requirements
- Associate or Bachelor's degree in life sciences, engineering or other related fields with 0-3 years in biopharmaceuticals or highly regulated industry.
- Must possess extensive knowledge and experience in drug product manufacturing support operations and have solid understanding of cGMP compliance requirements for a manufacturing facility. Previous experience in buffer preparation and visual inspection are preferred.
- Proven experience in risk mitigation planning and ability to solve complex manufacturing operation support related problems. Ability to make appropriate judgment and rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.
- Proven track record of supervising manufacturing team in manufacturing industry. Excellent communications skills. Great team player and ability to build positive collaboration with internal stakeholders, 3rd party contractors and clients to achieve alignment and work effectively.
- Must work in a self-motivated, highly flexible, well organized and detailed-oriented style in this leadership position with requirement of some evening conference call time and occasional international travel.
Nice To Haves
- Previous supervisory experience preferred.
Responsibilities
- Be responsible for all supporting activities related to aseptic cGMP compliant fill/finish operation, including but not limited to buffer preparation, formulation and compounding operation, visual inspection of finished product.
- Train and supervise drug product manufacturing supporting team for the execution of manufacturing support activities.
- Maintain the drug product suite in an inspection-ready state.
- Develop, author, review and approve SOPs/protocols for manufacturing related activities for GMP aseptic fill/finish operation.
- Responsible for ensuring manufacturing team members are trained on batch records, SOPs, equipment, and all relevant trainings as required.
- Accountable for schedule execution, adjustments, and performance of work assignments for team to ensure adequate staffing across assigned activities.
- May be required to work Shifts, Holidays and weekends.
- Other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Industry
Chemical Manufacturing
Education Level
Associate degree
Number of Employees
5,001-10,000 employees
