Engineer II, Drug Product Manufacturing
WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing.
About the role
This is a full-time position, reporting to the Manufacturing Head of DP12. The Engineer I 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 supervising a team of technicians responsible for manufacturing support activities such as buffer preparation, visual inspection of finished product, and other tasks as assigned. Responsible for providing direct oversight, coaching, mentoring, and leadership in drug product manufacturing activities according to current Good Manufacturing Practices (cGMPs).
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.
- Learn, train, and supervise drug product manufacturing support 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.
- Ensure 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.
Requirements
- GED with 8–10 years of experience, or Associate/Bachelor degree with 3–5 years of experience, or Master’s with 1–3 years of experience in life sciences, engineering, or other related fields or highly regulated industry.
- Must possess extensive knowledge and experience in drug product manufacturing support operations and have a 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 a manufacturing team in the manufacturing industry.
- Excellent communication skills.
- Great team player with the 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 detail-oriented style in this leadership position with the requirement of some evening conference call time and occasional international travel.
- Previous supervisory experience preferred.
Skills
- Strong knowledge and understanding of current Good Manufacturing Practices (cGMP).
- Biologics drug product manufacturing processes and procedures.
- Teamwork and interpersonal/communication skills.
- Personnel management and project management.
- Business acumen/commercial awareness.
Onerous Requirements
- Position may require occasional travel to global WuXi Biologics sites and/or client sites.
- Position is an individual contributor role for a manufacturing facility and may require occasional night and weekend hours.
Pay
The anticipated base pay range for this position is $66,200 to $105,900.