Staff Engineer / Senior Staff Engineer - Biologics Process Development

Company: Takeda Pharmaceutical
Location: Charlestown
Posted on: May 16, 2022

Job Description:

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Job DescriptionJob DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Staff Engineer / Senior Staff Engineer - Biologics Process Development (Viral Vector Purification Focus) in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:Provides theoretical/conceptual input to the design, development and execution of research assignments for a specific project or projects within the functional area. Independently plans and executes most unit operation characterization and optimization experiments within expertise and develops an awareness of unit operations in other areas.The role will have cross-functional leadership opportunities on high visibility projects. Responsible for significant or sole technical leadership within project or complex study. Prepares technology transfer documentation, regulatory documents, and reports or coordinates with team members to ensure execution. Represents line functions on CMC teams as appropriate/necessary. Proactively identifies process or study issues/challenges and proposes potential resolutions.Develops project or significant technical strategy within area of expertise. Leverages technical skill(s) as a resource/expert within the department. 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.

POSITION ACCOUNTABILITIES:The role will have cross-functional leadership opportunities on high visibility projects. The successful candidate will lead interns/co-ops and potential future contractors. 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.The Staff Engineer / Senior Staff Engineer - Biologics Process Development reviews, interprets, and communicates data cross functionally within CMC and project teams. Coordinates with 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, BEHAVIOURAL COMPETENCIES AND SKILLS:PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 0-3 years relevant industry experience Master's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3-5 years relevant industry experience Bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 7-10 years relevant industry experience Technical expertise in downstream process development of biologics, viral vector experience is a plus. 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 is a plus Experience in working in a multi-disciplinary team environment Previous experience contributing to regulatory filings

TECHNICAL FOCUS AREA/SPECIFIC QUALIFICATIONSThe position will be a key contributor within a group responsible for upstream and downstream process development. In support of purification process development the group performs the following activities: 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 mammalian sources (adherent and/or suspension) Purification of different biologic modalities: Viral vectors (LV, gRV, etc.), Non-Fc recombinants, MAbs, and Fc-fusion proteins Chromatography (IEX, Affinity, HIC, Mixed-mode) Filtration (depth filtration, sterilizing filtration, ultrafiltration/diafiltration) Familiarity with cell culture processes and analytical characterization of proteins is preferred.The candidate must have 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.

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 objectivesTRAVEL REQUIREMENTS:May require approximately 10% travelEffective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason..... click apply for full job details

Keywords: Takeda Pharmaceutical, Boston , Staff Engineer / Senior Staff Engineer - Biologics Process Development , Other , Charlestown, Massachusetts