Senior Staff Engineer at Millennium Pharmaceuticals, Inc. in Boston, Massachusetts

Job Description:

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Job Description

OBJECTIVES:

Develops project or significant technical strategy within area of expertise. Leverages technical skill(s) as a resource/expert within the department. Prepares and coordinates completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and reports within expertise for review. Coordinates transfer of projects as necessary. Identifies and plans broader technical objectives (project and scientific related) and initiates processes meet objectives with input from manager as needed. Identifies and recommends vendors as appropriate. Coordinates cross-functional teams and resolutions, with a focus on scientific /technical challenges.

ACCOUNTABILITIES

• Develops and leverages strategic understanding of project and CMC priorities to plan/coordinate with cross-functional peers and evaluate impact of decisions across CMC and other development functions


• Contributes significantly to complex/multiple projects or functional areas through leading or influencing others


• 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 CMC and project teams.  .


• Coordinates others in creating technical reports including reviewing and editing


• 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 CMC.


• Represents functional area on project teams by communicating activities from designated functional area to project team 


• Identifies topics for initiatives and leads local/global initiatives as directed by senior staff.


• Ensures a productive and development-rich environment; provides training/mentoring for junior staff.


• Defines more complex/novel approaches and methodologies to solving complex technical challenges 


• 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.   


• Initiate and influence project direction outside department.

EDUCATION, EXPERIENCE AND SKILLS:

Education and Experience:

Required:

• Bachelors degree in chemistry, biology, pharmacy, or related pharmaceutical science and 11+ years relevant industry experience


• Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 9+ years relevant industry experience


• PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3+ years relevant industry experience


• Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP’s


• Sound knowledge of current Good Manufacturing Practices (cGMP)


• Previous experience with the use of contract facilities


• Experience in working in a multi-disciplinary team environment


• Previous experience contributing to regulatory filings

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. Demonstrated ability to successfully contribute across multiple scientific endeavors


• 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, and corporate goals and timelines; management of internal external resources (vendors)


• 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.

TRAVEL REQUIREMENTS:

May require approximately 10% travel.

LINE FUNCTION SPECIFIC QUALIFICATIONS

The Sr. Staff Engineer will be a key contributor within a group responsible for performing purification process development, including small-scale experiments, scale-up, technology transfer and support for programs that bring new bio-pharmaceutical products to pre-clinical, clinical and commercial manufacturing phases. The candidate will design and carry out experiments for purification process development, optimization and characterization studies for therapeutic proteins. The scope includes IND- and BLA-enabling studies and preparation of regulatory submissions. The experimental studies involve both lab scale and pilot plant runs, including, but not limited to toxicology, clinical and validation batches.

This person must have extensive knowledge and experience on phase-appropriate purification process development and associated unit operations, including

• Product harvesting (clarification and capture) from production bioreactors


• Purification from both microbial and mammalian sources


• Purification of different biologic modalities: Non-Fc recombinants, MAbs, and Fc-fusion proteins


• Chromatography (IEX, Affinity, HIC, Mixed-mode)


• Filtration (depth filtration, viral filtration, sterilizing filtration, ultrafiltration/diafiltration)


• Familiarity with cell culture processes and analytical characterization of proteins is preferred.

The candidate must have solid experience in design of experiments, process monitoring, process risk assessment, statistical analysis and the ability of interpreting data and deriving conclusions. The candidate must demonstrate excellent written and verbal communication skills. Contributes to the preparation of CMC sections of regulatory filings. Authors and reviews high quality technical reports and presentations for management and peers. Independently refers to procedures, policies and practices for guidance. Contributes to publications in the field of expertise. Knowledge of cGMP manufacturing is required.

Locations

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Worker Sub-Type

Time Type

Full time