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 Manager I, Technical Operations - Small Molecules in our Boston, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.
As Manager 1, Technical Operations Small Molecules, primary responsibilities will be to:
- Support commercial manufacturing of drug substance, drug substance manufacturing process design, optimization, scale-up, technology transfer, validation and regulatory filings
- Reduce manufacturing risk through participating or leading as appropriate technical analysis of data related to global manufacturing of commercial biologics drug substance
- Contribute to an environment of continuous improvement through creation of process knowledge and maintain the product life-cycle management
Monitor and trend manufacturing data to demonstrate process is in a state of control.
Act as the primary contact for consolidation of technical transfer documents to vendors.
Review and interpret manufacturing data and communicate results to impacted line functions.
Be a technical representative between Technical Operations and drug substance CMOs (both internal and external).
Author/contribute to pertinent standard operating procedures (SOPs) and manufacturing process instructions that reflect the goals of a continuous improvement environment.
Author/contribute to technical reports and memos in support of commercial manufacturing that reflect the goals of a continuous improvement environment.
Provide technical leadership in the preparation, or evaluation, of Change Controls.
Lead investigations and provide Corrective Action Preventive Actions (CAPAs) that are consistent with continuous improvement.
- Provide guidance and leadership to support Pharmaceutical Operations groups, such Supply Ops, Quality Assurance (QA), and Quality Control (QC) in compiling and analyzing production data.
- Author and review relevant dossier sections related to commercial manufacturing submissions.
- Identify, and test, strategies to reduce manufacturing risks and maintain the product Life-cycle management.
Manage/Supervise interns, contractors and FTE s as appropriate.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
The candidate should have a BS in chemistry, chemical engineering or other scientific discipline and 5+ years of experience working in commercial pharmaceutical/chemical industry.
The candidate should have a good working knowledge of cGMP manufacturing operations, and/or drug substance manufacturing with experience with small molecule preferred.
The preferred candidate will also have a background in QA or other industry relevant background. The candidate needs to have working knowledge of CMC regulations, cGMP, and ICH guidance s.
The candidate should have an advanced knowledge in Excel as well as other Microsoft Office suite software. Other analytical software usage such as JMP or MATLAB is also preferred.
The candidate should have working knowledge and understanding of DoE and QbD etc.
The candidate should have demonstrated written and oral communication skills and ability to work in a cross functional team environment.
Ability to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
Position requires up to 20% domestic and international travel.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.