SR. MANAGER/ASSOCIATE DIRECTOR, EXTERNAL MANUFACTURING

Syncopation Life Sciences, Inc.
Published
June 14, 2022
Location
San Mateo, CA
Category
Job Type

Description

At Syncopation Life Sciences, upending the status quo is in our DNA. We combine a deep understanding of CAR T resistance with a vision of transforming peoples’ lives through the development of next generation cell therapies that provide deeper and more durable responses to a growing number of patients.

Syncopation is an exciting biotechnology company founded by Crystal Mackall and Robbie Majzner to develop next generation CAR T cell therapies designed to achieve superior efficacy by pre-empting important drivers of drug resistance. Our lead program includes a differentiated and clinically validated CD22 CAR that is in clinical development for patients with B-cell malignancies. To help move this and other programs forward, Syncopation has brought together a passionate and seasoned team to develop a focused portfolio strategy. Our team is based in San Mateo, California.

Join us to help make a difference.

POSITION SUMMARY

Syncopation is hiring a Sr. Manager/Associate Director, External Manufacturing skilled in managing relationships with and overseeing operations at contract development and manufacturing organizations (CDMOs). The position will be responsible for overseeing 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 therapy operations. The 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 Mateo, CA or for the right candidate, based remote from an east coast-based location.

WHAT YOU WILL DO AT SYNCOPATION

  • 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; proactive communication of expected risks, delays and budget variances to management and technical leads
  • Effectively manage critical issues, investigations and changes associated with manufacture
  • Development and monitoring of key performance indicators to evaluate the effectiveness of the joint relationship and progress toward joint objectives
  • Development and implementation of scalable business processes for external manufacturing team
  • Negotiating and managing service agreements; proposals, scopes of work and change orders; budgets and invoices; forecasting and planning activities
  • Supporting regulatory submissions and inquiries as they relate to site or manufacturing

THE RIGHT STUFF

PREFERRED QUALIFICATIONS:

  • Bachelor’s degree in engineering, life sciences or related fields. 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
  • Ability to travel domestically and internationally up to 25% of the time
  • Experience with CDMO strategic sourcing and/or service agreement contracting
  • Experience supporting biologics CMC regulatory submissions
  • Ability to lead scenario planning, options analysis, risk management activities
  • Experience in working with multidisciplinary teams. Experience working in a small biotech/start up 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, external collaborators highly desired.
  • motivated, excel 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

EEO & EMPLOYMENT ELIGIBILITY

Syncopation Life Sciences, 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. Syncopation Life Sciences, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requires of applicable law.

Syncopation Life Sciences requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Syncopation, and it applies regardless of whether the position is located at a Syncopation 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 held religious beliefs, you will have an opportunity to request a reasonable accommodation.

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