Gmp Product Development Manager

4 weeks ago

San Diego, United States Revvity Full time

**Job Summary**

This position is responsible for managing the Scientists and Research Associates to develop and launch ancillary reagents used for the Gene & Cell Therapy product manufacturing, such as antibodies, cell isolation kits and cell culture media.

The manager will work closely with their teams to assure proper training is conducted and performance expectations are clearly communicated. The manager is responsible for identifying potential leaders within the group and supporting team members continued development and promoting safe behaviors, high team morale, and good work ethics.

This position will partner with Manufacturing, Quality Control, Quality Assurance, HR as well as other support groups to drive continuous improvement, and to provide the highest quality products at an outstanding value, along with superior customer service and technical support.

**Essential Functions**

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Lead and manage the Exploratory PD group for developing new products under ISO9001:2008/ISO13485:2016.
- Manage and support the optimization and trouble-shooting for existing processes and products
- Maintain scientific and technical knowledge, and critically evaluate scientific literature and industry trends in order to contribute to new product development
- Effectively communicate project progress, experimental results and strategies in presentations and written reports
- Create SOPs, WIs and Forms that efficiently and effectively control processes and meet our ISO and regulatory requirements, and ensures all personnel are trained and complaint to the appropriate new and existing procedures in a timely manner
- Maintain and monitor group operational documentations and laboratory equipment
- Create and enact plans and projects that support group short
- and long-term performance goals, budgets, and BioLegend’s business strategy
- Ensures that the assigned departments and employees adhere to all policies, procedures and regulations governing processes, products, and employees as well as environmental, health and safety requirements
- Provide ongoing leadership, support and mentorship of direct reports and department team members
- Other projects or responsibilities as may be required.

**iACT Competencies**
- ** innovate **- Be better, keep improving, be more efficient, creative, and be in the forefront of development
- ** Aspire **- Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights
- ** Collaborate **- Foster teamwork, common goals, selflessness, communication and mutual support
- ** Transform **- Adapt, learn, re-invent and change for future development and growth

**Minimum Qualifications **-** Education and Experience**
- PhD in Immunology, Cell Biology, Biochemistry or related scientific field
- 3+ years of progressive leadership experience
- 8+ years of hands-on experience with in depth, working knowledge of technology, procedures, assay, and equipment used in cell analysis, primary cell isolation, and cultures

**Preferred Qualifications - Education and Experience**
- 5+ years of progressive leadership experience
- Strong leadership skills including people management, time management, and project management
- Effective verbal and written communication skills in English
- Understanding and working knowledge of cGMP and ISO13485 guideline as well as quality management systems
- Experience in Gene & Cell Therapy ancillary reagent industry
- Proven history of effective People and Project Management

**Work Environment & Physical Demands**

**Office**

While performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.

**Lab**

While performing the duties of this job, the employee regularly works in a laboratory environment with occasional data entry on a computer. Occasional exposure to a warehouse environment.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.

**Warehouse**

While performing the duties of this job, the employee regularly works in a warehouse environment with occasional data entry on a computer. Oc

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