Associate Director/Director Technical Process Development

The Position 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. Applying for this role is straight forward Scroll down and click on Apply to be considered for this position. 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 Bachelors 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. #LI-CA1 #ptcareers 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. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. #J-18808-Ljbffr