Information Technology Jobs in Monterey Massachusetts

ModernaTX, Inc. seeks a Supervisor, Quality Assurance Operations for its Norwood, Massachusetts location.

Heres What Youll Do:

• On behalf of a global biotechnology company, maintain responsibility for quality oversight of clinical operations.
• Responsible for ensuring quality oversight of mRNA platform in clinical manufacturing.
• Provide real-time quality leadership and on-the-floor operational support for the clinical manufacturing team.
• Make quality decisions that may impact operations, ensuring appropriate escalation.
• Coordinate training, professional development, and growth of the Clinical Quality Assurance team.
• Monitor process operations to ensure compliance with procedures and specifications.
• Demonstrate knowledge of standard manufacturing compliance, quality disposition, and quality system review.
• Identify risks and communicate gaps for quality and GMP process/systems.
• Enforce adherence to current Good Manufacturing Practices (cGMPs), standard operating procedures (SOPs), and manufacturing documentation.
• Partner with manufacturing and support management teams to focus on site initiatives.
• Oversee and perform review of executed electronic and paper batch record documentation.
• Support product disposition.
• Supervise approximately 4 Quality Assurance Operations Associates/Specialists.

Heres What Youll Bring to the Table:

Minimum requirements:

• Requires a minimum of a Bachelors degree, or foreign equivalent, in Chemistry, Chemical Laboratory Technology, Manufacturing Engineering or a related field and 4 years of experience in the position offered, or as a Quality Assurance Specialist, Sr. Specialist, or related position.
• Alternatively, employer will accept an Associates degree in the stated fields and 5 years of experience in the stated positions.
• 4 years of experience must include:
  • Quality assurance in early and late-stage clinical products applying Good Manufacturing Practices (cGMP) and FDA guidelines;
  • Leveraging knowledge of Quality Management Systems (QMS) to review and approve deviations, change controls, and corrective and preventive actions (CAPAs);
  • Collecting, analyzing, and interpreting data related to quality metrics, defect rates, and process performance indicators; and
  • Performing risk assessments and implementing mitigation strategies.
• May telecommute up to 2 days per week.

Apply at https:///en-US/M_tx (Job ID: R17937) or email resume and cover letter to with subject line: R17937.

At Moderna, we believe that when you feel your best, you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Our Working Model

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

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

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

Were focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at .

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

TheSenior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers.

This role will:

• Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product
• Evaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis
• Propose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale
• Propose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product
• Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing
• Identify and order materials required to perform development and manufacturing
• Identify tooling and equipment required to perform development and manufacturing
• Create documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards
• Due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality
• Propose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product
• Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions
• Analyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product
• Maintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
• Study effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product
• Develop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product
• Write technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests
• Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines
• Lead/support validation activities including equipment validation and process validation
• Lead problem solving and investigate quality events related to formulation process or batch records
• Propose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards
• Lead or participate in root cause analysis and quality event investigation such as OOS and deviations
• Supervise, mentor and develop team members or relevant personnel across departments

This role requires:

• A minimum of three (3) years of experience in pharmaceutical research and manufacturing
• Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science
• Experience in sterile manufacturing is preferred
• Experience in lyophilization and terminal sterilization techniques are a plus
• Knowledge of parenteral drug product manufacturing
• Proficient with calculation, data analysis, statistics and applied mathematics

FULL-SERVICE SHOPPER

Start earning quickly with a flexible schedule

Shopping with Instacart is more than grocery delivery. Shoppers help make our world go round. They make money, make moves, and make shopping lists come true. They make good time, make life easier, and make peoples day.

Shoppers make it all happensign up now to help create a world where everyone has access to the food they love.

As a full-service shopper, youll receive orders through the Shopper app to shop from stores in your area, and deliver the orders to your customer's door. Its that simple.

What you get as a shopper:

• Start earning quickly on a flexible schedule*
• Weekly pay with the option of instant cashout
• Potential to earn tips
• Special earnings promotions

Basic requirements:

• 18+ years old (21+ to deliver alcohol)
• Eligible to work in the United States
• Consistent access to a vehicle and a recent smartphone

Additional information:

Shopping with Instacart is great for anyone looking for flexible, seasonal, home-based, entry-level, weekend, weekday, after-school, or temporary opportunities. As an Instacart Full-Service Shopper, you can have more flexibility than with a part-time job.

Instacart is committed to diversity and providing equal opportunities for independent contractors. Instacart considers qualified individuals without regard to gender, sexual orientation, race, veteran, disability status, or other categories protected by applicable law.

Instacart also values providing prospective contractors with a fair chance to pursue opportunities. For all individuals seeking to provide services in San Francisco, Los Angeles, and Philadelphia, Instacart considers individuals in a manner consistent with the requirements of applicable Fair Chance ordinances.

Review the Independent Contractor Agreement here

*Subject to availability of batches in your area.

Required

Preferred

Job Industries

• Other