Job Description
Manager / Sr. Manager, External Manufacturing (Remote)
Manufacturing
Regular Full-Time
Salary Range
Min: $95,000.00
Max: $180,000.00
Job Description
This role supports tactical operational activities associated with contract manufacturing organizations (CMOs) and manufacturing partners developing, producing and/or testing Atara products, key raw materials, and intermediates. This role:
- Serves as a point of contact for all activities occurring at CMO including, manufacturing, planning, supply chain, quality, testing, regulatory, inspections, projects, and business relationship with the CMO.
- Leads and supports on-the-floor manufacturing activities, manufacturing and validation readiness activities, championing of deviation investigations, corrective/preventative action implementation, and change control management, as well as support for regulatory inspections.
- Proactively provides strong scientific leadership and hands-on support and troubleshooting for all aspects of technology transfer, process scale-up, process monitoring, manufacturing, QC testing, packaging and logistics activities.
- Fosters cross-functional working relationships with internal and external groups, lead interactions between Atara Process Sciences, Quality Assurance, Supply Chain and Project Leadership and external manufacturing entities to ensure successful development and delivery of all products.
- Provides support for regulatory submissions related to products manufactured at the CMO manufacturing sites for which this role has accountability.
Location: Thousand Oaks, CA (Flex schedule) OR Remote
Reports to: Sr. Director, External Manufacturing
Travel: Domestic and international travel will be required (up to 75%)
Primary Responsibilities:
- Acts as Person-in-Plant (PiP) to oversee all aspects of operations at CMOs and works with CMO to implement improvements and necessary corrections to ensure compliant cGMP operations in line with any regulatory filings and product specifications
- Tracks and maintains budget related to activities at the CMO and is responsible for ensuring activities complete per project timelines.
- Leads and supports operations (technical, quality, supply chain, manufacturing, QC, packaging and logistics) activities associated with the manufacture of products at CMOs and partners.
- Partners with CMO to ensure successful manufacture of products required for clinical supply, process validation and/or commercial supply.
- Supports guidance for process validation activities at the contract manufacturing facility. Provides technical input to Process Sciences for defining the critical parameters of new and existing processes.
- Collaborates with manufacturing quality partner and internal Atara quality teams to develop processes and systems that enable compliant, successful technology transfers, operation and lifecycle management of cGMP clinical and commercial manufacturing processes, ensuring all product delivery schedules are met.
- Provides technical depth to support troubleshooting efforts and leads high-level deviation investigations.
- Drives timely decisions and facilitates active communication and information flow between contract manufacturer and Atara team members.
- Authors technical documents for regulatory agency submission in support of manufacturing processes and serves as process subject matter expert in health authority interactions.
- Identifies and drives process optimization initiatives and addresses opportunities for efficiency and capacity improvements.
- Partners with Process Sciences and Quality teams to identify and drive process optimization initiatives and address opportunities for efficiency and capacity improvements.
- Owns and drives change controls to make necessary changes to cGMP processes.
Qualifications
- For the Manager role – Bachelors in a biological science with 6+ years of experience or Master’s and 4+ years of experience in biologics development including cell therapy development.
- For the Sr. Manager role – Bachelors in a biological science with 8+ years of experience or Master’s and 6+ years of experience in biologics development including cell therapy development.
- Demonstrated experience supporting technology transfers, cGMP manufacturing operations and CMC regulatory submissions and inspections required.
- Fundamental knowledge in cell biology, cell culture, cell processing and cell cryopreservation principles.
- Breadth of knowledge across cell culture technologies, cell processing technologies, cell characterization methods, manufacturing under cGMP, validation, Quality Systems and regulatory requirements.
- Demonstrated in-depth skills in contract negotiation, budgeting and project management.
- Demonstrated track record of effective leadership and partnership in a contract manufacturing setting.
- Clear and concise communicator who is a team player and a proven negotiator.
- Expert problem-solver that leads with data, seeks subject matter expertise and is considerate of others point-of-view.
- Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environment.
- Effective interpersonal skills as both a team leader and a team player.
- Strong leadership presence with ability to garner respect through sound technical analysis, business judgment and clear decision-making.
- Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive decisions among individuals from a variety of cultures and disciplines.
- Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust).
