Manufacturing Technical Manager

Yoh has a contract opportunity for a MANUFACTURING TECHNICAL MANAGER to join our client in South San Francisco, CA.

JOB OVERVIEW:

The general purpose of the Technical Manager, Manufacturing Associate role is to bring in-depth knowledge and experience to departmental projects. As such, the Technical Manager, Manufacturing Associate is responsible for coordinating, initiating and executing department objectives and driving goal attainment. They work closely with internal and external partners/stakeholders to ensure best fit and alignment of developed/implemented initiatives. A fundamental working knowledge of safety, quality systems and quality assurance concepts is required including the application of current Good Manufacturing Practices (cGMPs). Incumbents in the Technical Manager, Manufacturing Associate role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of activities.

JOB RESPONSIBILITIES:
- Manage and resolve technical and compliance issues with Manufacturing, Quality, Technology, Product Development, Maintenance Execution & Safety, Security, Health & Environmental (SHE).
- Responsible for identifying and implementing improvements in staff development in areas such as cGMP training, technical skills, safety, performance management.
- Identify the technical, procedural and equipment issues that may compromise production and compliance, working closely with cross-functional groups to identify and implement solutions.
- Implement and follow through on corrective and preventative actions for variances.
- Represent the department in reviewing and approving production related documentation requiring approval such as process validation protocols and final reports, planned and unplanned variance reports, documentation change requests, engineering and facility change requests.
- Ensure that all operations are performed with 100% compliance to documentation cGMP standards.
- Ensure maintenance of a safe manufacturing work environment that complies with company and state regulations.
- Evaluate data, resolve complex problems, and provide input to investigations
- Manage project teams to troubleshoot and support continuous process improvement.
- Submit reports and compile data for trending and identifying problem areas.
- Oversee the manufacturing input for the prompt closure of Adverse Trends through corrective action implementation.
- Applies a complete understanding of theories and concepts from one's technical/professional discipline to independently address a broad range of difficult problems.

Job Qualifications:
- Bachelor's degree or relevant experience (Life Science/Engineering is preferred) plus five to seven (5-7) years of experience
- Three to five (3-5) years of experience with a Masters (Assumes a Bachelors)
- Experience with the operation and management of biopharmaceutical manufacturing facilities.
- Possesses thorough knowledge and understanding of cGMPs and familiarity with FDA, ICH, and European guidelines.
- Proficiency with relevant software including, but not limited to Microsoft Word, Excel, Visio, Project and SAP.
- Manages assignments that are complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Hannah Cihlar

Yoh is a professional staffing provider with over 70 years of experience in the short - and long-term staffing services industry.

Yoh, a DayJ2W: CLINICAL; J2W: SCIENTIFIC

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