Director/Senior Director of Process Development & Manufacturing
700 Technology Square, Flr 2 Cambridge, MA 02139 US
The Director/Sr Dir of Process Development and Manufacturing will be responsible for drug substance and drug product process development and manufacturing, managing the CDMO activities for clinical/commercial manufacturing of large molecules, and provide hands-on leadership on regulatory/manufacturing strategy. He/she will oversee process characterization, process validation, technology transfer, process registration, and preparation for commercialization at current and potential vendors. The successful candidate will leverage their deep knowledge of bio process development and manufacturing to support our innovative science in the creation of a new medicines that transform patients’ lives.
This role will report to the Senior Vice President, Chief Technical Operations Officer.
Roles & Responsibilities:
- Responsible for all manufacturing efforts for NBE from development through commercialization
- Working with contract development manufacturing organizations (CDMOs) and contract research organizations (CROs), lead clinical/commercial manufacturing, supply chain management for drug substance and drug product manufacturing
- Serving as a subject matter expert in drug substance process development, lead manufacturing process scale-up, process transfer, process characterization, process validation, and GMP manufacturing
- Oversight of the manufacture, testing and release of drug substance, drug products, and clinical supplies
- Develop the manufacturing strategy aligned with the CMC regulatory strategy, in compliance with applicable regulations and guidelines
- Develop and manage plans to commercialization including process validation strategy, supply strategy, and commercial manufacturing agreements
- Responsible for successful execution of process validation including PPQ, shipping validation, packaging validation, and other validation requirements for BLA
- Manage and author CMC documentation including CMC/Quality sections of regulatory submissions (IND/CTD/BLA), technical reports to support filing, the agency meeting briefing packages, and responses to regulatory agency questions
- Collaborate with cross functional teams, interface closely with Quality and Regulatory functions, and CDMOs to ensure compliance, science-based decisions, accuracy and completeness of technical documents and submissions
- Develop commercial manufacturing strategy considering future clinical and commercial demand, financial investment, CMO relationships, inventory management, and supply risk
- Establish operational timelines, scheduling, manage resourcing and budget for all manufacturing related activities to meet program goals
- Proactively identify risks and issues in CMC programs, including potential quality and regulatory risks, drive risk assessment, develop solutions and drive to resolution
- Identify opportunities to optimize the drug substance manufacturing process, focusing on process robustness, consistency, and economics, as well as phase-appropriate improvement aligned with the regulatory strategy
- A Ph.D. degree in Bio/Chemical engineering, Biochemistry, Pharmaceutical Sciences, or Protein Chemistry with more than 10 years of VeCMC process development and manufacturing experience. Equivalent experience may be accepted. A minimum of 8 years of industrial experience in development of biologics (NBE) is required.
- Demonstrated competency, experience, and knowledge in CMC development and manufacturing requirements from early to late phases within the bio/pharmaceutical industry
- Specific hands-on experience in one or multiple of the following focus areas: upstream or downstream process development, manufacturing science and technology (MSAT), process design, process characterization, process validation, and commercial manufacturing of large molecules
- Knowledge of bio analytical methods, characterization and bio product formulation, and fill/finish technology
- Experience in MBRs, EBRs, SOPs, GMP documents review and authoring and commercial manufacturing support
- Experience in managing CDMOs/CROs for drug substance/drug product manufacturing and testing. Ability to work effectively with external manufacturing vendors globally.
- Good understanding of cGMP, ICH, USP guidance and standards and FDA/EMA regulations relating to CMC and manufacturing for biologics.
- Experience in authoring and reviewing relevant technical documents and CMC sections for IND/BLA submission. Experience with late-stage regulatory filings including BLA section authorship preferred.
- Demonstrated project leadership experiences from early-stage to late-stage drug substance process development, preferably through registration and validation batches
- Demonstrated ability to prioritize and manage multiple tasks simultaneously, identify and resolve issues, and effectively manage timelines
- Ability to work effectively independently and collaboratively in a team environment in a rapid-paced, cross-functional environment. Ability to lead and challenge multifunctional teams, facilitate decision-making, work effectively in cross-cultural environments
- Strong communication (oral, written and presentation) skills; highly organized, efficient, detail oriented, flexible self-starter with clarity, accuracy and conciseness
- Travel and work flexible hours as required
Pay ranges from $150-300k **salary will be commensurate with experience**
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