Senior Manager/Director Technical Process Development

Pharma Technical Development (PTD) focuses on developing robust manufacturing processes and quality control systems to efficiently transform scientific ideas into products. PTD reliably delivers quality products to patients enrolled in clinical studies around the world. PTD excels by creating an engaging and inclusive environment where everyone can bring their skills and talents to developing innovative medicines.

This position is part of the Global Drug Product Process Engineering group within PTD and is focused on robust process development for parenteral drug products to drive excellence and innovation and ensure seamless network-wide execution across Biologics, synthetic molecules, peptides, and Gene & Cell Therapy. Members collaborate closely with global peers, technical development teams, and key stakeholders in Manufacturing, Quality, and Regulatory to support clinical manufacturing and commercial product launches, ensuring harmonized technical strategy implementation and efficient process validation.

The Opportunity: 

In this role, you will guide a team dedicated to developing robust drug product manufacturing processes for clinical and commercial stages, ensuring globally harmonized strategy implementation and efficient execution within the Drug Product manufacturing network.  Additionally, you will:

• Lead, manage and develop a team of 6-10 scientists and engineers focused on drug product process development across various modalities such as Biologics, synthetic molecules, peptides, and Gene & Cell Therapy

• Oversee the development, characterization, and validation of filling, lyophilization, and freeze/thawing processes

• Ensure process designs for clinical and commercial stages are robust for effective validation and successful commercialization

• Provide technical oversight and support for drug product transfers and equipment-related process engineering

• Implement Quality by Design (QbD) principles and continuous improvement initiatives to enhance process engineering outcomes

• Foster collaboration within and across teams, including partnerships with CMOs and other Roche departments, to drive seamless execution and strategic integration

• Serve as a sponsor for strategic process engineering projects, guiding process development alignment and resource prioritization across the network

Please note:  We offer the opportunity to join our team as either an Senior Manager or Director, depending on your experience and qualifications.

Requirements for Senior Manager:

• You possess a Bachelor’s degree in a scientific or engineering discipline along with 8 or more years of relevant experience in the biopharmaceutical industry 

• You have proven team leadership and people management or matrix leadership experience

• You have demonstrated excellence in leading engineering projects related to drug product processing and equipment, strategic thinking, and problem-solving

• You have a strong understanding of phase-appropriate GMP and regulatory requirements in the US and Europe

• You possess technical expertise in parenteral process development and readiness to oversee end-to-end pharmaceutical development, including regulatory submissions

• You have demonstrated experience thriving in an organizational culture of enterprise thinking and coaching

• You are a strong communicator with excellent collaboration skills and a track record of building and maintaining productive relationships

• You have had experiences leading innovation and driving results, embracing LEAN principles and collective leadership

• You are able to travel up to 20% domestically and internationally

Requirements for Director:

• You meet the qualifications for the Senior Manager level along with 12 or more years of relevant experience in the biopharmaceutical industry 

• You have a substantial and proven track record in team leadership and people management, including direct and matrix leadership experience

• You have demonstrated excellence in leading complex engineering projects related to drug product processing and equipment

• You possess expert technical expertise in parenteral process development and readiness to oversee end-to-end pharmaceutical development, including regulatory submissions

• You possess demonstrated experience in enterprise thinking, coaching, and leading innovation, with a strong ability to drive results and foster a culture of collective leadership and strategic integration

• You have a proven ability to prioritize resources effectively across the network and sponsor strategic process engineering projects, ensuring alignment and successful execution within complex organizational structures

Relocation benefits are approved for this posting.  

The expected salary range for this position based on the primary location of California is $156,170 (min) - $223,100 (mid) - $290,030 (max) for the Senior Manager and $177,100 (min) - $253,000 (mid) - $328,900 (max) for the Director.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed in this link.

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Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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