Technical Manager/Sr Technical Manager Validation

California, United States of America

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The Position

Job Responsibilities

  • Provide quality oversight of technology transfers, process validation, process and product monitoring activities, and maintenance of the validated state of the manufacturing process
  • Ensure current Good Manufacturing Practice (cGMP) requirements are met for the validation of manufacturing processes and qualification of systems
  • Review and approve qualification and validation documents
  • Apply knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations and industry standards
  • Support the successful execution of qualification and validation of the manufacturing systems and processes
  • Participate in local change management process as change assessor
  • Provide technical knowledge and expertise to support quality investigations and CAPAs involving the manufacturing systems and processes
  • Provide quality oversight of the development, review and approval of drug substance master production records
  • Participate in quality risk assessments as a process validation subject matter expert
  • Provide technical guidance for study design including sampling plans, acceptance criteria and rationale
  • Support health authority inspections, and internal and partner audits
  • Review and approve relevant sections of health authority submissions
  • Collaborate with customers to ensure qualification and validation activities are executed compliantly, with efficiency and effectiveness
  • Troubleshoot and support the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships
  • Review and approve SOPs and other GMP documents in the respective area of responsibility
  • Participate in site and network activities to standardize qualification and validation approaches and address complex qualification and validation issues
  • Lead and participate in continuous improvement efforts

Job Requirements

Education and Experience

  • BA/BS or higher degree in engineering or life sciences or an equivalent focus of study
  • Minimum of 5 years work experience in the biopharmaceutical industry, preferably in manufacturing technical support and/or process development
  • Significant experience with technology transfers, process validation, and process and product monitoring activities within the biopharmaceutical industry

Knowledge, Skills and Abilities

  • Sound knowledge of cGMPs as they apply to biopharmaceutical manufacturing facilities and processes
  • Strong knowledge of manufacturing operations and qualification/validation of biopharmaceutical manufacturing systems and processes
  • Working knowledge of cell culture processes and purification processing techniques, including scale-up/scale-down
  • Strong knowledge of process validation approaches, industry standards, and applicable health authority regulations and guidance
  • Proficiency in statistical methods (i.e., statistical process control, multivariate data analysis techniques, etc.)
  • Must have excellent interpersonal, communication, and teamwork skills
  • Ability to independently evaluate situations and propose potential solutions
  • Ability to make sound decisions about quality and technical subjects
  • Ability to work collaboratively in cross-functional teams to achieve milestones and goals
  • Ability to interpret and relate Quality standards for implementation and review
  • Strong technical leadership; able to work independently or as part of a multidisciplinary team
  • Possesses strong verbal and written communication skills and the ability to influence at all levels
  • Capable at building trustful and effective relationships
  • Takes responsibility, drives results, and achieves expected outcomes
  • Able to think strategically and translate strategies into actionable plans
  • Flexibility in problem solving and work hours to meet business objectives

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.

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