The CMC Technical integrator is a key member of the Technical Development organization responsible for the lifecycle of CMC documentation including generation of original raw data through the authoring of source documents to support technology transfer, CMC sections of regulatory submissions, technical responses to related Health Authority (HA) questions and management of post-approval changes. The person filling this role uses their broad process/analytical development experience to contribute to defining control strategies and the scientific soundness of CMC documentation. They apply project management skills to develop the CMC documentation plan and timeline integrated with the CMC project teams. CMC leadership skills are employed to govern the authoring of scientific content for eCTD source documents, including coaching development scientists and orchestrating documentation reviews and approvals. CMC regulatory strategy and technical writing experience is used to produce high quality technical content and identify/mitigate CMC risks to ensure CMC dossiers comply with regulatory requirements and fulfill regulatory agency expectations in collaboration with Regulatory Affairs. The Technical Integrator facilitates innovation and problem-solving using the principles of operational excellence to drive continuous improvement of CMC documentation processes and content including capturing/sharing of lessons learned within the organization.
Here's What You'll Do:
Using source documentation provided by CMC functions, support CMC subject matter experts in the writing sections of regulatory documents including INDs/IMPDs, BLAs/MAAs/NDAs, DMFs. Responsibilities will include:
Here's What You'll Bring to the Table:
- Engage the CMC subject matter experts in regular meetings to understand their needs and the technical elements of the writing projects
- Independently read and digest technical documentation pertaining to the development, manufacture, and testing of various and complex biotech products, asking appropriate questions and conducting independent research as needed to enable the writing of CMC sections for regulatory submission
- Mine technical documents for relevant data, synthesize information, develop narratives, and construct flow diagrams, tables, and figures as needed to convey technical information
- Organize and continuously improve the flow of information from the original raw data sources, through formal documentation and regulatory submissions.
- Keep abreast of pertinent health authority guidance, regulations, and trends.
- With guidance from manager, GLOBAL team, and clients, utilize prior experience and knowledge of GMP and regulatory requirements to ensure that the content and level of detail is fit for purpose and appropriate for that product's development stage
- Ensure high quality deliverables are generated at appropriate stages and under agreed-upon timelines
- Review and provide feedback on the work of colleagues; contribute your technical expertise to the team and be open to learning/cross-training in other technical areas; lead and develop other team members as needed
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- 10+ years biotech experience in process development, manufacturing, analytical sciences, technology transfer, regulatory CMC, or a combination thereof
- BS degree or higher in engineering or biological science
- Experience contributing to/authoring regulatory CMC submission components and GMP/technical documents
- Familiarity with CMC content of BLAs, INDs, CTAs, and DMFs, and applicable guidance documents
- Working knowledge of the quality concepts used in the GMP production and development of biotech products such as PPQ, method validation, CPPs/CQAs, IQ/OQ/PQ, raw material testing and qualification, reference standards, comparability, and risk assessments
- Excellent writing skills and proficiency with Word; comfort with other standard programs in the Microsoft Office suite of products and with Adobe
- Adequate computer skills for troubleshooting basic and common IT issues to minimize downtime
- Professionalism and self-motivation to work independently and reliably deliver on assignments
- 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 winter shut down
• 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.
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