Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Senior Level Analytical Development CMC Opportunity

Expired Job

Vista Technology Boston , MA 2108

Posted 7 days ago



(Small Molecules)


  1. Have you experience in leading | building a team of Analytical professionals?
    1. Does this include managing cross-functional teams?
  2. Have you experience in managing contract organizations (CRO | CMO)?
    1. Does this include Technology Transfer?
  3. Have you experience interacting with the FDA? EMA?
    1. Does this include answering agency questions? Preparing Briefings?
  4. Is your technical experience in developing | validating analytical methods for small molecule drugs?
    1. Does your experience include oral solid dose formulation?

If you have answered YES to the above questions, you likely qualify for this EXCITINGopportunity to join a growing Company.

Contact us now for additional details

Call: 978.686.2200 OR


Schedule a Time To Talk With The Recruiter:

Visit our Company Website

Visit our Career Opportunities Page

See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
CMC Senior Scientist/Associate Scientific Fellow Analytical Development

Takeda Pharmaceuticals North America

Posted 2 weeks ago

VIEW JOBS 11/20/2018 12:00:00 AM 2019-02-18T00:00 By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that I agree with Takeda's Privacy Notice, Privacy Policy and Terms of Use. Job Description Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a CMC Senior Scientist/Associate Scientific Fellow working on the Analytical Development team, you will be empowered to leverage your technical and leadership skills to represent Analytical Development-Biologics on cross-functional Global CMC Teams by linking all scientific efforts to company, program and functional goals, and a typical day will include: POSITION OBJECTIVES: * Develops project or significant technical strategy within area of expertise * Leverages technical skill(s) as a resource/expert within the department and across division to contribute across multiple projects * 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 to meet objectives with input from manager as needed * Identifies and recommends vendors as appropriate * Directs and manages outsourcing across a product platform as appropriate * Coordinates cross-functional teams and resolutions, with a focus on scientific/technical challenges POSITION ACCOUNTABILITIES: * Significant technical responsibility for a project area/technical program within the department and potentially across CMC (i.e. Global CMC Team lead) * Represents functional area on GCT project teams by communicating activities from designated functional area to project team * Insures effective project management of all plans and projects with area of responsibility, linking all scientific efforts to company, program and functional goals * 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 * 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 LINE FUNCTION SPECIFIC QUALIFICATIONS: * Significant experience with a broad variety of biochemical analytical techniques, including but not necessarily limited to liquid chromatography, gel or capillary electrophoresis, spectrometry and spectroscopy methods * May have significant knowledge in specialized subdisciplines such as protein mass spectrometry or biophysics * Able to lead cross-program development activities for multiple methods * Able to conduct troubleshooting for complex technical issues and to lead major characterization studies * Strong understanding of protein structure/function and of technical and regulatory expectations regarding analytical development and product characterization * Serves as a SME for more complex methods * Defines critical technical or scientific gaps within AD-Bio * General lab competencies such as equipment maintenance and compliance activities EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS: Education and Experience: * 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 * 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 audienc; 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 PHYSICAL DEMANDS: * Use hands on a regular basis to perform experiments and handle small laboratory equipment * Able to lift or move up to 40 pounds in the course of daily work * Exposure to hazardous/toxic chemicals and reagents TRAVEL REQUIREMENTS: * May require approximately 10% travel WHAT TAKEDA CAN OFFER YOU: * 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 Learn more at No Phone Calls or Recruiters Please. #LI-SM1 Empowering Our People to Shine Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Takeda Pharmaceuticals North America Boston MA

Senior Level Analytical Development CMC Opportunity

Expired Job

Vista Technology