Senior Manager, External Manufacturing

Reporting to the Senior Director, External Manufacturing, CARGO Therapeutics is hiring a Senior Manager, External Manufacturing skilled in managing relationships with and overseeing operations at Contract Development & Manufacturing Organizations (CDMOs).
The position will be responsible for supporting all activities for Clinical and eventual Commercial External Manufacturing operations, driving multiple projects forward and assuring critical material and product supply.
The position will be responsible for the management of one or more CDMOs with the current focus of either viral vector operations or cell processing operations.
This position will also have tactical responsibility for authoring and implementing scalable business processes for the External Manufacturing team with guidance and support from the Head of External Manufacturing and input from cross-functional team members.
The role includes responsibilities for establishing service agreements, scopes of work and change orders thereto, as well as budgets and forecasts for each CDMO relationship under management.
Further, the candidate will manage all aspects of production planning, capacity assessment, production readiness, oversight of batch processing, leveraging the matrix team to resolve batch related issues, and coordinating product logistics with Supply Chain.
The ideal candidate is a highly-motivated individual who can use their business acumen and technical knowledge to establish and sustain strong external relationships to drive high performance from our manufacturing partners.
The individual will have opportunities to collaborate and work cross-functionally.
The role is based in San Carlos, CA but may also be suitable for an East Coast-based Remote arrangement.
WHAT YOU’LL DO AT CARGO THERAPEUTICS Manage one or more external CDMO sites for Clinical and eventual Commercial supply Serve as the main point of contact with CDMO partner and lead cross-functional matrix team with main objective for assuring product supply Execute strategies that drive effective operational performance and service levels Lead scenario planning and risk management activities related to the site operations, key objectives, and product supply; provide proactive communication of expected risks, delays and budget variances to management and technical leads Effectively manage critical issues, investigations and changes associated with manufacture Develop and monitor key performance indicators to evaluate the effectiveness of the joint relationship and progress toward joint objectives Develop and implement scalable business processes for External Manufacturing team Negotiate and manage service agreements; proposals, scopes of work and change orders; budgets and invoices; forecasting and planning activities Support regulatory submissions and inquiries as they relate to site or manufacturing THE RIGHT STUFF: Required Experience & Qualifications Bachelor’s degree in engineering, life sciences or related fields with 8-10+ years pharma/biotech experience in a Technical Operations role Previous experience with one or more cell and gene therapy modalities (e.
g.
viral vectors, autologous cell therapies, plasmids) Previous experience managing CDMO relationships or working for contract manufacturing organizations Experience with CDMO strategic sourcing and/or service agreement contracting Experience supporting biologics CMC regulatory submissions Ability to lead scenario planning, options analysis, and risk management activities Experience working with multidisciplinary teams; experience working in a small biotech/startup environment is a plus Strong problem-solving skills for developing creative, innovative solutions, and meeting project objectives are required Highly-organized and capable of leading/pursuing multiple projects independently Experience with GMP requirements and interfacing with QA (Quality Assurance), technical teams and external collaborators highly desired.
Independently motivated, excels at driving execution, detail-oriented, creative approach to problem solving, and adept at working in a fast-paced environment Must have interpersonal, organizational, written, and verbal communication skills, and the ability to work hands-on and collaboratively in a team environment Ability to travel domestically and internationally up to 25% of the time PAY RANGE The combined pay range for this role is $142,000 - $195,000.
Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.
ABOUT CARGO THERAPEUTICS CARGO Therapeutics, Inc.
is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients.
CARGO’s programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply.
CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy.
CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies.
Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic “cargo” designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion.
CARGO’s founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products.
For more information, please visit the CARGO Therapeutics website at https://cargo-tx.
com/.
Join us to help make a difference! EEO & EMPLOYMENT ELIGIBILITY CARGO Therapeutics, Inc.
is committed to building a diverse, equitable, and inclusive company.
We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status.
CARGO Therapeutics, Inc.
also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law.
CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date.
This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote.
If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.