Synthetic Molecule Process Development (SMPD) is responsible for the development of robust and cost-effective processes for the manufacture of new small molecule pharmaceuticals, along with methods for achieving and controlling high standards of purity and quality.
The successful candidate will be responsible for all aspects of reaction & particle engineering including the development of scale down models for the study of unit operations as well as technical transfer to external contract manufacturing organizations. He/ she will have deep experience in using process analytical technologies (PAT) in combination with mathematical models (both statistical & first principle) to enhance process understanding to effectively develop/ optimize/ scale-up and troubleshoot processes. The Senior Engineer will have experience building scale-down equipment and developing innovative advanced process control strategies for both batch and continuous processes.
They will be recognized as a technical resource/expert within SMPD and across Pharmaceutical Sciences and utilize his/ her technical expertise to contribute across multiple projects and drive technical/scientific strategy. The Senior Engineer will be responsible for benchmarking current trends in research, development and manufacturing technologies, developing initiating and/or participating at a high level in projects that involve extraordinary, well-considered risks along with scientific/technical challenges, as well as directing and managing outsourcing across a product platform, as appropriate.
Develops project or significant technical strategy and leverages technical skill(s) as a resource/expert within the department
Contributes significantly and independently to project work which may include multiple projects within functional area.
Plans and implements resolutions to technical problems/issues
Independently designs and executes experiments, and reports results
Recommends, justifies and implements technologies and innovations.
Owns a discipline/technical skill in its entirety and continues to develop expertise in other key technical skills.
Influences and supports initiatives related to driving scientific and technical improvement within function and potentially cross-functionally.
Reviews, interprets and communicates data cross functionally within pharmaceutical sciences and project teams
Conducts analysis of technical and conceptual risk and trends
Identifies process trends and defines/champions process strategy or use of novel technologies
Recognized as a technical expert and resource within function
Significant technical responsibility for a project area/technical program within the department and potentially across Pharmaceutical sciences
Identifies topics for initiatives and leads local/global initiatives on behalf of senior staff.
Defines appropriately complex/novel approaches and methodologies to solving outstanding technical challenges
Coordinates and leads technology transfer to internal or external manufacturing sites
Responsible for authoring relevant sections of regulatory documents, validation plans, reports and peer reviewed manuscripts.
Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals.
Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors.
Represents Takeda and is an active member on pre-competitive collaborations with academic and industrial partners.
Education and Experience:
A Ph.D. degree with 3+ years of academic, post-doctoral or pharmaceutical industry experience; an MS degree with 9+ years of pharmaceutical industry experience; or a BS degree with 11+ years years of pharmaceutical industry experience. Degrees in chemical engineering required.
Experience in the use of mathematical, both statistical and first principle, models as well as advanced process control systems preferred
Experience in building reaction kinetic models as well as process models preferred.
Experience in building laboratory and pilot plant equipment a plus
Experience in crystallization process development and scale-up with an emphasis on form, purity and particle size control a plus
Experience in the use and scale-up of milling technologies (both dry and wet) for particle size control a plus
Experience in the use of process analytical technologies (FT-IR, NIR, FBRM, UV-vis, etc.) required
Experience in building chemometric models preferred
Experience in developing continuous processes a plus
Sound knowledge of current Good Manufacturing Practices (cGMP) preferred
Experience working in a pilot plant a plus
Previous experience with the use of contract facilities and managing technical transfers a plus
Experience in working in a multi-disciplinary team environment
Proven scientific track record through presentations at scientific conferences and publication of pier reviewed manuscripts
Knowledge and Skills:
Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and, determine causes and possible solutions
Teamwork -- Ability to work well on global cross-functional teams.
Communication Skills -Able to expresses one’s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates with senior management; technical writing skills to support authorship and approval of internal technical documents
Organization – Exercises good time management and prioritization skills to balance multiple project and departmental objectives
Technical - Subject matter expertise in a specific scientific area or areas.
Knowledge Sharing - Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use
Resource Management -Project management skills; ability to manage one’s time within individual, departmental
External Involvement – Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Interacts with external vendors for projects
Leadership Skills – Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.
May require approximately 10% travel.
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
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 and company match of charitable contributions
Family Planning Support
Flexible Work Paths
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Locations
Cambridge, MAWorker Type