Sr. Engineer II, Process Development

Norwood, MA, United States

Sr. Engineer II, Process Development page is loaded Sr. Engineer II, Process Development Apply locations Norwood, Massachusetts Technical Development time type Full time posted on Posted Yesterday job requisition id R14837 The Role:

Our team looks forward to welcoming an experienced Bioprocess Engineer with a strong background in the regulated (bio)pharmaceutical environment supporting laboratory, pilot and commercial scale process development, mRNA technology transfer to internal and external GMP production facilities and commercial production of mRNA therapies. Our team’s goal is to implement and support robust commercial manufacturing processes. This Senior Engineer role requires close working relationships with Analytical Development, Manufacturing Sciences and Technology, Manufacturing, Supply Chain, Quality, Regulatory and Program Management functions as well as with external CMO teams. The incumbent will also help develop industry skills in high-performing junior team members both at the bench and in GMP manufacturing facilities.

We are establishing commercial processes that require a solid practical foundation in standard bioprocess unit operations ( e.g. UF/DF, normal flow filtration, mixing systems, chromatography). The ideal candidate should have a strong background of supporting commercial operation of these unit operations with a focus on pro-active process improvements and optimization, effective troubleshooting, interfacing with existing teams to collaboratively resolve process investigations and implement appropriate controls to ensure robust commercial manufacturing. These skills should be complemented with a track record of excellent written and oral communication skills and experience operating within a Quality Management System. A history of process development and process investigation accomplishments using scaled down models, QbD-principles and process characterization/modeling techniques are strong pluses.

Success in this role would be demonstrated by effective participation in process investigations, design and performance of experiments to identify/confirm associated root causes, followed by characterization and implementation of effective process changes to increase success in commercial production. This position bears the potential for significant growth in a dynamic organization.

Here’s What You’ll Do:

Provide subject matter expert (SME) expertise and representation in cross-functional process investigations for commercial processes.

Support process investigations by active participation in root cause assessment exercises utilizing standard-industry tools

Design and execute detailed experiments to assess and confirm root causes of process deviations and identify effective mitigation tools.

Cross-functionally support establishment of appropriate CAPAs needed to improve robustness of commercial manufacturing processes.

Identify opportunities for pro-active process improvements and optimization based on commercial performance data to improve robustness of commercial manufacturing process.

Interface extensively in a matrixed environment with process development teams for process investigation support, assess new technologies, support on-going process characterization and post-approval changes.

Support technology transfer and establishment of commercial process at new manufacturing sites and provide Person-in-plant (PiP) support as needed.

Perform GMP activities with adherence to Quality Management System requirements.

Mentor junior team members. Supervisory role may be included.

Communicate clearly with program stakeholders, technical staff and external CMO partners.

Generate high quality source documentation to support regulatory filings.

Here’s What You’ll Bring to the Table:

BS with a minimum of 8 years, or MS with a minimum of 5 years, or Ph.D with a minimum of 2 years of industry experience in bioprocess development and/or manufacturing sciences. Engineering-related degree preferred.

Demonstrated background of providing technical support to commercial manufacturing processes, including but not limited to, support of process investigations, implementation of pro-active process modifications and support of post-approval changes

Experience with mature quality management systems, deviation management, change controls and CAPA implementation

Experience with lipid nanoparticle process development and mRNA process development is preferred.

Experience in large molecule process development (late phase/commercial experience preferred)

Knowledge of the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation.

Strong operational skills, interdependent project/timeline management capabilities.

Strong interpersonal skills with an eagerness to support colleagues across the organization and in partner organizations.

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!

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.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

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

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 proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at [email protected] . (EEO/AAP Employer)

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At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.

We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission : To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision : To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies

M oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.

Reasonable Accommodation Notice

Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing [email protected] if you need assistance completing any forms or to otherwise participate in the application process.Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

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