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Downstream Staff Engineer

Company: Takeda Pharmaceutical
Location: Marlborough
Posted on: August 7, 2022

Job Description:

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Staff Engineer - Biologics Process Development (Purification Focus) in our Lexington, 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 work towards 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.


Provide theoretical/conceptual input to the design, development and execution of research assignments for a specific project or projects within the functional area. Independently plan and execute most unit operation characterization and optimization experiments within expertise and develops an awareness of unit operations in other areas.

  • You will have cross-functional leadership opportunities on high visibility projects. Responsible for significant or sole technical leadership within project or complex study. Prepare technology transfer documentation, regulatory documents, and validation plans and reports or coordinates with team members to ensure execution. Represent line functions on CMC teams as appropriate/necessary. Proactively identifies process or study issues/challenges and proposes potential resolutions.
  • Develop 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.
    • Understand project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional, and external stakeholders
    • Provide technical leadership to project teams within area of expertise and commits resources to execute specific project tasks.
    • Contribute significantly and independently to project work which may within functional area.
    • Review, interprets, and communicates data cross-functionally within CMC and project teams.
    • Plan and implement resolutions to technical problems/issues
    • Represent functional area on GCT project teams by communicating activities from designated functional area to project team
    • Support local and global initiatives which may include leading initiatives or work streams
    • Serve as a technical resource for junior staff and leverages expertise in laboratory technology as a functional resource/trainer.
    • Independently designs and executes experiments, and reports results
    • Helps develop project strategy and communicates complex data/decisions within department and cross functionally as necessary
    • Build and maintain relationships with key vendors and assists with technical aspects of vendor negotiations
    • Analyze manufacturing issues and coordinates potential resolution with the CMC team.
    • Integrate scientific/technical efforts around cross-functional

      Education and Experience:

      • Bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 8+ years relevant industry experience
      • Master's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 6+ years relevant industry experience
      • PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 0+ years relevant industry experience
      • Bachelor's: 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
      • PhD: Demonstrated mastery of subject or area related to field
        Knowledge and Skills:
        • Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and possible solutions
        • Teamwork -- Ability to work well in cross functional team environment and across global line functions.
        • Communication Skills -Able to expresses one's self concisely within team; documents issues and/or concerns with colleagues; adjust communication style for the audience; timely and effectively communicates issues to supervisor; technical writing skills to support authorship of internal technical documents
        • Organization - Exercise good time management and prioritization skills and can manage multiple tasks simultaneously
        • Knowledge Sharing - Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use
        • Resource Management -Ability to manage one's time within individual, departmental, and corporate goals and timelines; management of all resources (vendors)
        • External Involvement - Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events
        • Technical - Subject matter expertise of applicable lab equipment and operations
          • May require approximately 5-10% travel.

            The 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.

            You will 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 characterization of proteins.
              You must have experience in design of experiments, process monitoring, process risk assessment, statistical analysis and the ability of interpreting data and deriving conclusions. You must demonstrate excellent written and verbal communication skills. Contribute to the preparation of CMC sections of regulatory filings. Author and review high quality technical reports and presentations for management and peers. Independently refer to procedures, policies and practices for guidance. Contribute to publications in the field of expertise. Knowledge of cGMP manufacturing is required.

              • 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
                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, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.

                Empowering Our People to Shine
                ..... click apply for full job details

Keywords: Takeda Pharmaceutical, Boston , Downstream Staff Engineer, Engineering , Marlborough, Massachusetts

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