Moderna Hiring for API Pilot Plant Operations Director, Process Chemistry Job at Norwood, MA Full Time

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 Company’s growing pipeline of products.

Here’s What You’ll 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 MBR’s, SOP’s, 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 URS’s, PFD’s, 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

Here’s What You’ll 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
• D iscretionary 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 person’s 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. #LI-AG1

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