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The Role:
This position is part of Moderna’s Manufacturing Sciences and Technology (MST) team responsible for ensuring robust production of Drug Substance (DS) using our mRNA manufacturing platform at our Norwood site. The Director/Senior Director will have full responsibility for both clinical and commercial GMP manufacturing support and be an integral member of the internal manufacturing leadership team.
Here’s What You’ll Do:
Lead MS&T teams supporting cGMP drug substance manufacturing of Moderna’s late-stage clinical and commercial mRNA products, as well as select critical starting raw materials and starting materials
Lead MS&T teams providing technical support for process monitoring, on-floor support, change control, deviation investigations, and CA/PA for all DS workcenters – DNA, chemistry, small-scale clinical DS production, and large-scale clinical/commercial DS production
Lead MS&T teams providing centralized investigation and CA/PA leadership support on behalf of the internal manufacturing organization
Lead technical product stewards responsible for managing the site-based new product introduction and process qualification strategies across all technologies and scales, across the program lifecycle
Author, review, or otherwise contribute to clinical and commercial regulatory filings and health authority question responses. Support inspection readiness and response activities.
Develop MS&T strategy, plan resource needs and hire and manage employees to meet organizational needs for the present and future.
Communicate with executive leadership to drive alignment of critical decisions, strategy, and risk mitigations.
Collaborate extensively with Manufacturing, Quality, Digital, Technical Development, Supply Chain and others to ensure operational excellence in making product.
Obsessively focus on decreasing variability in the manufacturing environment through practical application of data and operational.
Collaborate with multiple functions to ensure the manufacturing site maintains a high state of compliance through continued improvements in raw material control, control of microbial contamination, control of consumables quality, control of cleaning, and control of equipment performance. Monitor and improve these critical manufacturing areas through continuous monitoring, data analytics, and collaboration with QA, QC, and Facilities & Engineering.
Here’s What You’ll Bring to the Table:
Biochemical engineer, chemical engineer, or biological/chemistry science degree with >12+ years of experience in the pharmaceutical or biotechnology industry. Advanced degree preferred (MS, Ph.D.)
Prior leadership experience managing MS&T, Process Development, or Technical Development groups or function for a pharmaceutical or biotechnology company. Demonstrated ability to mentor and develop a technical staff.
Knowledge in CMC strategy, ICH guidelines, and regulatory support tasks (IND, BLA, RTQ, and PAI).
Extensive knowledge of quality systems, cGMP, and industry standards at all phases of drug development.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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The Role
Moderna is seeking a manager to help support site start up activities for our Commercial Individualized Neoantigen Therapy (INT) Program. This role will be based in Marlborough, Ma but may require regular travel to the Norwood, Ma location. As a Manufacturing Manager, you will lead a cohesive team responsible for manufacturing cGMP mRNA medications and leading start up activities from project phase to commercial manufacturing. The individual in this role will be accountable for leading a team in support of an automated, fast paced and short turnaround operation to deliver a mRNA medicine to patients. He/she will apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The individual will play a key role in the commercial production ramp up in the Marlborough, MA facility by supporting commissioning activities while leading manufacturing operations. They will hire and develop a high-performing, flexible manufacturing team capable of meeting a fast-manufacturing operation timeline. This position demands a blend of scientific knowledge, operational expertise, and digital proficiency. You'll be an integral part of site startup team responsible for operational readiness, execution of Engineering and PPQ runs during the project phase which will last through 2024. The role will then transition into manufacturing of patient batches for 2025.
Here’s What You’ll Do
Safely oversee the manufacture of mRNA medicines while adhering to Moderna’s safety procedures and guidelines.
Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to manufacture mRNA medicines and deliver on time startup project objectives.
Lead development of batch records, SOPs and training materials for startup of commercial manufacturing at the Marlborough Facility.
Closely partner with QA peers for rapid disposition of Moderna medicines.
Develop comprehensive project plans and monitors the achievement of business and financial goals.
Development of effective working relationships with both internal and external partners.
Provide mentorship / coaching of Supervisors and Manufacturing Associates.
Ability to manage multiple projects in a fast-paced environment.
Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
Leverage Lean and Six Sigma principles to foster and drive a culture of continuous improvement.
Ability to manage people.
Here’s What You’ll Need (Basic Qualifications)
A BS in engineering or sciences and 8+ years of experience in cGMP manufacturing processes in a pharmaceutical or biotechnology environment; 6+ years with a Masters.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Previous leadership role leading and developing teams.
Project management experience.
Strong communication skills, working across a dynamic and complex operation.
Subject Matter Expert on root cause analysis, complex investigational tools, change management and continuous improvement execution.
Technical writing skills and proficient in GMP manufacturing processes including but not limited to TFF Systems, Chromatography systems, single-use process materials/consumables use, fermentation and cell banking operations.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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The Role
Moderna is seeking a Sr. Specialist, INT Manufacturing to help support site start up activities for our Individualized Neoantigen Therapy (INT) Program. This role will be based in Marlborough, Ma but may require regular travel to the Norwood, Ma location. The individual in this role will be part of a cohesive team responsible for manufacturing top-quality mRNA-based medicines reporting to the Manufacturing Manager. The Specialist uses expert knowledge of cGMP manufacturing practices, bioprocess unit operations, process engineering and digital systems to act as a technical leader for the manufacturing team. The Sr. Specialist will be a key player in the development of operational procedures and training material, investigating issues that arise, and driving projects within the team focused on delivering Right First-Time results in an efficient manner. You'll be an integral part of site startup team responsible for operational readiness, execution of Engineering and PPQ runs during the project phase which will last through 2024. The role will then transition into manufacturing of patient batches for 2025. Standard working hours are from Monday to Friday during the day shift and then will transition into shift work when manufacturing begins. The shift work may include 2nd shift and weekends.
Here’s What You’ll Do
Practices and promotes safe work habits and adheres to safety procedures and guidelines.
Provide on-the-floor support of the manufacturing team in execution of the process, cGMPs, and safety practices.
Lead cross-functional teams to drive complex manufacturing operation changes, improvements, and issue investigations.
Lead process SMEs in the development of batch records, SOPs, and training materials.
Closely partner with QA peers for rapid disposition of batches, including ensuring timely batch record, protocol, and log reviews, deviation investigation support, etc.
Lead investigations and CAPA implementation for manufacturing deviations.
Lead Change Control implementation for tech transfers and other continuous improvement initiatives.
Lead ops readiness for new product introductions, technology transfers, and major capital projects.
Support equipment start-up, commissioning, and validation activities.
Maintain a flexible schedule based on the demands of production and projects.
Lead resolution on issues and constraints that have the potential to impact business objectives and/or project timelines.
Participate in regulatory audits as SME for specific process areas.
Here’s What You’ll Need (Basic Qualifications)
A BS in engineering or sciences and 5-8 years of experience in cGMP manufacturing processes in a pharmaceutical or biotechnology environment.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Knowledge and understanding of cGMPs.
A proven track record of success in leading or participating in complex projects within a dynamic pharmaceutical or biotechnology manufacturing environment.
Proficient in computer use for various business aspects, including executing electronic batch records, viewing procedures, and reviewing and approving documents.
Self-motivated and highly organized.
Excellent communication skills.
Technical writing skills and proficient in GMP manufacturing processes including but not limited to TFF Systems, Chromatography systems, single-use process materials/consumables use, fermentation and cell banking operations.
Experience with coaching and mentoring junior team members.
Embodies Moderna’s core values: Bold, Curious, Relentless, and Collaborative.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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Official account of Jobstore.
The Role
In this role, you will support the SAP PP/QM modules along with integration of S/4 HANA with 3rd parties’ application (MES / LIMS and customs Moderna applications) across a pharmaceutical manufacturing environment. This position will play a key role in supporting our personalized cancer vaccine clinical phase 3 trial.
This is a great opportunity for someone to who has always wanted to a have a great impact on shaping the outcome of supply chain solutions in a fast-paced pharmaceutical environment.
Here’s What You’ll Do
Be the key point of contact for manufacturing / quality and internal logistics PCV business units
Techno functional expertise in SAP PP/QM amodules to configure and maintain world class integrations to meet current requirements and emerging pharmaceutics supply chain challenges
Possess expert knowledge of BOMs, Production Version, Recipe, Resources, process / production orders, inspection types, inspection plan, control characteristics…
Strong knowledge of PP integration with other modules like EWM, MM, QM.
Perform business analysis and SAP ERP S/4 system support of the supply and manufacturing business units in a fast-paced clinical drug manufacturing environment.
Process expert in Make to Order process
Partner with digital MES, quality systems and internal custom Moderna application teams to support and enhance integration with external systems (MES / LIMS / Informatics Apps)
Support data analysis, program debugging and report writing.
Write business design documents, functional specs, test scripts, SOPs
Implement SAP projects to drive continuous improvement.
Additional duties as may be assigned from time to time
Here’s What You’ll Need (Minimum Qualifications)
BS/BA degree or equivalent experience
5-8 years of experience in the design, configuration and testing of solutions across an SAP system.
Specific experience in the following submodules
Manufacturing and Quality (PP-PI and QM)
Material Management (MM) & Inventory management (IM)
EWM module integration with PP-PI and QM
Familiarity with the technical integration between SAP and partner systems using middleware applications exchanging data with standards such as EDI and EPCIS.
Multiple years of experience engaging with regulatory business stakeholder or regulatory agencies.
Experience with proposing functional solutions to developers when writing functional specs.
Experience in an FDA regulated environment such as Pharma/Medical device.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
MS degree
Familiarity of SAP S/4 is a plus.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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