Principal/Senior Principal External Collaborations Site Manager

Roche Pharma Global Technical Operations (PT) delivers a fast evolving portfolio of new Cell & Gene Therapy (CGT) products to bring new curative treatments to patients. This portfolio of new products comes with the great promise to bring unprecedented medical advances to patients but also presents unique challenges: living products (e.g. cells / tissue) need to be delivered to patients in highly personalized supply chain models, which meet fast turn-around-times at a zero-error quality level.

The Opportunity:

As the primary External Collaborations liaison between our internal PT Cell & Gene Therapy functions and external partners, you will lead cross-functional teams to perform the selection, implementation, management, and decommissioning of Contract Development & Manufacturing Organizations (CDMOs), Contract Laboratory Organizations (CLOs) and service providers to enable Roche/Genentech`s portfolio of novel Cell and Gene Therapy modalities. With a focus on ensuring "on time in full" delivery and effective risk management, you will contribute to the advancement of groundbreaking medical advances in personalized supply chain models.  Additionally, you will be responsible for:

• Leading the evaluation of external parties´capacity and capability to support sourcing decisions.

• Developing and negotiating contracts, including financial agreements, RFPs, MSAs, SOWs, and POs together with Procurement

• Partnering with Quality Assurance to ensure appropriate qualification & oversight is provided for GxP suppliers throughout their lifecycle.

• Conducting due diligence activities for the in-licensing of new CGT products

• Overseeing project and business activities at external parties, managing development, manufacturing, testing, logistics, and technology transfers

• Identifying and escalating risks and issues that may affect project timelines, resources, finances, or business relationships with PTC Senior Management

• Leading the JMT (Joint Manufacturing Team) with relevant internal and external SMEs to enable successful execution of project and daily business activities incl. continuous improvement.

• Leading the Joint Steering Committee (JSC) per defined cadence to manage strategic aspects of the relationship (supply and quality performance, strategy) with Senior Management from both ends.

• Ensuring compliance with safety, health, environment, and quality requirements through audits and mitigation plans.

Who You Are: Note that this position can be hired as either a Principal or Senior Principal

Requirements for Principal External Collaborations Site Manager:

• You possess a Bachelor’s degree in Engineering or Life Sciences AND 8 or more years of experience working in an Pharmaceutical Operations environment (manufacturing, quality control, quality assurance or supply chain).

• You have proven experience in CMC development (analytical development, process development, MSAT or related support functions).

• You have proven experience in the field of Cell & Gene Therapies.

• You possess at least 3 years of experience managing large, complex cross-functional projects.

• You possess experience working with external parties in a GMP-regulated environment.

• You possess experience negotiating contracts with external parties.

• You have applied knowledge of state-of-the-art ATMP/CGT regulations in both quality and manufacturing.

• You possess knowledge of industry players, relative costs, and management of industrial partners.

• You possess proficiency with project management, organization, facilitation, problem-solving, and quantitative analysis skills.
   

Preferred:

• Advanced degree

• Background in in vivo / ex vito Gene Therapy or Stem-cell based therapy relevant fields (e.g., molecular biology).

• Familiarity with blood bank / apheresis operations for Cell Therapy applications.

• Experience leading within a matrixed organization and demonstrated success in managing multiple organizational interfaces and stakeholders.

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Requirements for Senior Principal External Collaborations Site Manager:

• You possess a Bachelor’s degree in Engineering or Life Sciences AND 12 or more years of experience working in an Pharmaceutical Operations environment (manufacturing, quality control and/or quality assurance).

• In depth experience in CMC development (analytical development, process development, MSAT or related support functions).

• You have proven experience in the field of Cell & Gene Therapies.

• You possess at least 5 years of experience managing large, complex cross-functional projects.

• You possess in depth experience independently executing projects with external parties in a GMP-regulated environment.

• You possess experience with CMC programs from early development stages to launch & commercialization.

• You possess experience negotiating contracts with external parties.

• You have applied knowledge of state-of-the-art ATMP/CGT regulations in both quality and manufacturing.

• You possess in depth knowledge of industry players, relative costs, and management of industrial partners.

• You possess proficiency with project management, organization, facilitation, problem-solving, and quantitative analysis skills.
   

Preferred:

• Advanced degree

• Background in in vivo / ex vito Gene Therapy or Stem-cell based therapy relevant fields (e.g., molecular biology).

• Familiarity with blood bank / apheresis operations for Cell Therapy applications.

• Experience leading within a matrixed organization and demonstrated success in managing multiple organizational interfaces and stakeholders.

The expected salary range for this position based on the primary location of California is $142,030 - $263,770 for the Principal and $166,460 - $309,140 for the Senior Principal. 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 at this link.

Relocation benefits are approved for this position.

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