API Pilot Plant Operations Director, Process Chemistry

The Role:
Reporting to the Senior Director of Process Chemistry, Moderna is seeking an experienced Engineer or Scientist to join the Process Chemistry group. The individual is expected to provide operations and technical leadership for pharmaceutical small molecule manufacturing at various scales and development stages ranging from kilo-lab to pilot plant and non-GMP pre-clinical to cGMP Phase III manufacturing.

The role requires kilo-lab operations within cGMP quality systems and adhering to clinical-stage regulatory guidelines for pharmaceutical small molecule ingredient manufacturing. The role also requires effective team leadership and cross-functional coordination. The process chemistry team is focused on well-defined small molecules including lipids, derivatized polymers, and small oligomer nucleotides in support of the Companys growing pipeline of products.

Heres What Youll Do:

• Oversee plant operations facility and team by coordinating and monitoring activities

• Provide necessary program direction (tracking and reporting tools) for planning, organizing, developing, and integrating projects across multiple functional areas

• Mentoring and managing a growing team of chemists, engineers, and technicians

• Hands-on lead in troubleshooting efforts related to processing and process equipment problems

• Provide technical expertise and guidance to establish robust unit operations and process characterization for late-stage materials

• Writes and/or reviews MBRs, SOPs, and other technical documents

• Ensures operations are in compliance with all Regulatory, EHS, and cGMP quality systems that assure proper design, monitoring, and control of manufacturing processes and facilities

• Manages the capital budget and raw material needs, production schedules, finished product inventories and logistics of shipments

• Evaluate and implement new technologies as needed

• Reporting of operations metrics and critical project updates to senior leadership

• Implements necessary plant improvements as dictated by business needs

• Produce key operations deliverables including URSs, PFDs, commissioning, start-up, and operator training

• Maintain Quality System and GMP training requirements

• Collaborates with the EHS group on environmental, health and safety-related aspects of all operations

• Participation in multidisciplinary alignment meetings, safety, and quality risk assessments

• Effectively partner with diverse internal stakeholders (process chemistry, analytical development, quality assurance, regulatory affairs, manufacturing science and technology, supply chain, quality control, facilities, and plant chemical operators) to build robust processes and supporting resources

Heres What Youll Bring to the Table:

• BS in Chemical Engineering, Process Chemistry or Physical Chemistry and a minimum of 10 years of industry experience in small molecule manufacturing including substantial GMP experience

• Proven ability to effectively lead a team

• Experience in small-molecule Kilo-lab or pilot plant operations

• Knowledge of chemical engineering principles including reaction kinetics, reactor design, chemical thermodynamics, process modeling, heat, and mass transport

• A solid understanding of organic chemistry

• Experience and familiarity with various process operations priorities including sourcing, technical transfer, R&D, process improvement, and troubleshooting.

• Business acumen including experience with Smartsheet or Microsoft project or equivalent management tool and proven ability to learn and adapt to new systems

• Understanding and experience in chemical process scale-up and manufacturing of pharmaceutical small molecules

• Solid understanding of practices required to conform to health agency guidelines that control the authorization and licensing of pharmaceutical products (GMP).

• Supply chain experience, including experience working with CROs and external suppliers

• Proven record of calm under pressure and a positive attitude

• Highly organized

• Ability to effectively collaborate

• Outstanding communication skills (verbal and written)

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  Vacation, sick time and holidays
  Volunteer time to participate within your community
  Discretionary year-end shutdown
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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