Associate Director, Contract Manufacturing
il y a 3 semaines
**The Role**:
Reporting to the V.P. External Manufacturing DP Operations, this position will coordinate and drive cGMP manufacturing activities at Moderna’s Drug Product Contract Manufacturing Organizations (CMO) to ensure on-time and in-full deliveries. This includes responsibility to ensure all operational related activities at the CMOs are conducted to meet all Moderna’s requirements.
**Here’s What You’ll Do**:
Lead cross-functional CMO Operations team to drive the successful execution of the operational and tactical plans. Partner with Quality, Technical Development, Manufacturing Science and Technology (MS&T), Supply Chain, Legal, Finance and Regulatory on all aspects of the relationships with the CMOs.
Responsible for ensuring that all operational related activities at the CMOs are conducted to meet Moderna’s requirements (Compliance, Dispute resolution, Production Planning, Materials Management, Technology Issues, OpEx).
Maintain presence at the external partners’ sites to build a strong collaboration and to enable fast action-oriented improvement plans as appropriate.
Oversee Contract Management Process with CMO. Partner with key Procurement, Legal and Finance in the preparation and negotiation of Statements of Work (SOW), Change Orders (CO) and supportive agreements. Ensure contract terms are executed including issuance of purchase orders, forecasts and other deliveries.
Ensure externally products are produced, tested, and stored in compliance with good documentation practices, and with registered conditions.
Approve instructions relating to external production operations and ensure their strict implementation by the CMOs
Ensure in collaboration with quality that the appropriate qualification, maintenance, trainings and validations are performed to meet the appropriate Moderna’s requirements.
In collaboration with Quality and MS&T, coordinate investigations and troubleshooting efforts at CMOs
Review and approve the appropriate GMP documentations as required e.g: change request, deviations, master batch records, annual product quality reviews (APR/PQR), internal SOP´s
Drive for and implement agreed continuous improvements at CMOs.
Collaborate with internal cross-functional teams to understand needs/expectations for CMO performance. Drive contract manufacturer capability and capacity to enable on-time and predictable delivery of the product.
Lead periodic reviews and execution of the MPS (Master Production Schedule)
Support the track and monitor of the External Manufacturing budget
**Here’s What You’ll Bring to the Table**:
**Education**: Bachelor degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering).
10+ years’ experience in Pharmaceutical/Biotechnology Industry
Experience with sterile manufacturing activities in GMP environment.
Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.
Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment.
Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
A leader who is self-reflective and leads by example and drives the organization’s performance with an attitude of continuous improvement by being open to feedback and self-improvement.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
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
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