Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Contract Manufacturing Organization (CMO) Senior Manager, in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As CMO Senior Manager working on the Global Pharmaceutical Operations team, you will be empowered and a typical day will include:
The CMO Senior Manager is responsible for managing the Global Contract Manufacturing relationships with commercial drug substance, drug product or finished goods packaging operations. The focus for this position is the management of oncology therapies, specialty biologics, and other key therapeutics distributed globally. This position works with Quality Assurance, Quality Control, Regulatory Affairs, and Technical Operations to ensure product quality and supply demand is consistently met for Takeda s oncology and biologics commercial products.
* Management of routine production at internal Takeda or external drug substance, drug product or finished goods packaging facilities.
* Manages the operational and business relationships with the internal or external manufacturing facilities.
* Facilitates joint steering committee meetings with the executive teams.
* Negotiates and balances the needs of the manufacturing facilities with those of the Pharmaceutical Operations group to create a collaborative business relationship.
* Delivers product in accordance with the manufacturing forecasts.
* Identifies scheduling conflicts at the facilities and implements corrective actions when required.
* Provides timely resolution of deviations and change controls associated with routine manufacturing.
* Triages out to Technical Operations for troubleshooting and management of in depth process investigations, as appropriate.
* Assists in scheduling material movements.
* Authors, reviews, and/or approves pertinent SOPs and manufacturing process instructions.
* Monitors and indentifies key process and business performance indicators for each of the sites and implement improvements as appropriate.
* Participates in the management of production data for use in the performance trending and metrics analysis. Enlists Technical Operations support for trending and analysis.
* Creates and manages purchase orders for projects supporting routine production.
* Leads a core team comprised of QA, QC, Regulatory Affairs, Technical Operations, Logistics, and Supply Operations Systems personnel to effectively manage CMOs.
* Authors or reviews pertinent Pharmaceutical Sciences sections for regulatory submissions.
* Supports technical process transfers to new facilities through the development of Master Batch records and design of material flows.
* Leads and participates in Pharmaceutical Sciences teams for key therapeutics distributed globally.
* May manage one or more CMO Managers or Associates.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
The candidate should preferably have a BS in chemistry, biology, or closely related scientific disciplines with 9+ yrs of experience working in or directly supporting manufacturing or pharmaceutical development. Higher levels of industry experience will be required for those candidates without a related scientific degree.
The candidate should have a good working knowledge of manufacturing operations within the scope of their job function. These operations may include some or all of the following: biologics drug substance manufacturing, drug product
manufacturing (oral solid dose and/or parenterals) pharmaceutical packaging, CMC regulations, cGMP, and sterility assurance techniques.
The candidate should have demonstrated written and oral communication skills and ability to work / lead in a cross functional team environment.
* Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
* Position requires up to 25% domestic and international travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.