Mapp Biopharmaceutical
  • San Diego, CA, USA
  • Full Time

Director of CMC Project Manager - Drug Product

Job #18-17A

Mapp Biopharmaceutical, Inc. "Mapp" is a biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases. The Director of CMC Project Manager -Drug Product is responsible for facilitation of the technical Drug Product scope and is directly responsible for management of scope, schedule, budget, risk, contractual reporting deliverables, and providing Drug Product vendor oversight. This person will also be the main CMC conduit into the clinical team and will be PM oversight for packaging and labeling, inventory monitoring, dissemination of Drug Product to CROs, and storage. The ability to effectively work within a virtual team is critical. The position requires less than 20% domestic travel and approximately 5% international travel will be required.

Basic Qualifications

  • BS in a scientific discipline or equivalent required; MS in a scientific discipline is an asset
  • Minimum of 5 years technical experience in a large molecule (notably monoclonal antibodies) Drug Development/Commercialization CMC role, such as, analytical, process, quality, supply chain
  • Minimum of 5 years in a Project Management role overseeing CMC-related effort within a Drug Development or related organization
  • Understanding of the Drug Development paradigm from Candidate Selection through Commercialization
  • Understanding of how all the CMC functions fit together to form the integrated CMC plan and on how CMC fits into the overall Product Development strategy (Clinical, Non-clinical and Regulatory)
  • Experience in leading a team through planning with an integrated schedule in Microsoft Project as the output, through tracking project schedule and budget progression, and through definition and management of risks, mitigations and contingencies
  • Experience in representing CMC scope of work and providing CMC updates to the overall program team and to stakeholders
  • Ability to provide effective project communications, verbal and written, tailored for specific audiences
  • Demonstrated organizational skills, strong verbal and written communication skills, and attention to detail
  • Ability to work independently (with minimal supervision) as well as work in a team environment with changing timelines and priorities

Preferred Qualifications

  • Experience with parenteral Drug Product manufacture
  • Experience with lyophilized Drug Product manufacture
  • Experience with US government funded programs

Responsibilities

  • Responsible for all Project Management deliverables related to CMC Drug Product for a specific program, including scope, schedule, budget, risk management, and government reporting deliverables
  • Leverages the PM tools, templates and guidances to track adherence to the CMC scope of work, schedule and budget and provide diligent management of the PM change control processes
  • Facilitates issue identification/resolution/monitoring and scenario planning as necessary
  • Identifies and manages potential issues, risks and constraints, conducts impact analysis, work with team to provide mitigation/contingency strategies and aids in crafting of stakeholder communications as necessary
  • Manages all vendor (CMO) relationships as the Mapp Point of Contact (POC) required to enable the execution of the CMC Drug Product scope, including but not limited to, Drug Product development and manufacturing site, analytical test site(s), clinical packaging and labeling, and storage. Assures all Project Management deliverables are being met by the vendor including scope management, schedule, budget, reporting and contractual requirements
  • Partners with CMC technical leads to facilitate the planning and execution of Drug Product-specific CMC scope including all aspects of development of the Drug Product process, manufacturing, clinical packaging and labeling, and analytical control strategy through the lifecycle of the program
  • Partners closely with the Clinical Project Manager and Clinical Operations in the supply and management of the clinical trial drug inventory
  • Oversees the storage of all CMC samples, final bulk Drug Substance and Drug Product
  • Coordinates the Drug Product information from the Mapp technical team to meet the Program contractual deliverables including monthly reports, regular updates etc.
  • Co-facilitates internal CMC team meeting, providing agendas, pre-reads, meeting minutes and action items

Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment with the opportunity to work remotely. Mapp wants you to join their team and invites you to apply.

No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.

Mapp is an Equal Opportunity/Affirmative Action/Disability/Vets Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

Mapp Biopharmaceutical
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