Scientist I, Analytical Technology

Job Description

About This Role

The Scientist I, Analytical Technology will lead the development and implementation of analytical technologies used for Advanced Process Control (APC) under GMP conditions in the QC and/or Manufacturing environment. The Scientist I will work closely with Analytical Development, QC and Manufacturing Sciences to develop and implement technologies such as LC-MS, in-line and at-line UPLC, SoloVPE, PATrol System, RI, and in-line PAT technologies for process monitoring, process control and real time release. Main responsibilities include analytical method validation per ICH guidelines, QC/MFG readiness/implementation and analytical method transfers. The Analytical Technology (AT) Scientist I will also be responsible for authoring the associated sections in regulatory filings and acting as the subject matter expert in regulatory inspections.

The AT Scientist I will ensure oversight and completion of all milestones associated with validation, and transfer activities in support of clinical and commercial product manufacture and testing; and ensure that laboratory and quality systems within the AT department remain in compliance with Biogen and industry cGMP standards.

WhatYou’llDo

The AT Scientist I will work and collaborate with scientists in Analytical Development, Quality Control, Analytical Technology, Manufacturing Sciences, Contract Laboratories and Instrument Vendors for evaluation and application of new analytical instrumentation and technology in advanced process control, method evaluation, development, validation, implementation, and transfer activities. The AT Scientist I will facilitate the achievement of Biogen goals and initiatives through timely and appropriate communication with appropriate stakeholders throughout the organization.
  • Lead the implementation of in-line, at-line and off-line analytical technology for advanced process control and/or real time release testing. This includes authoring phase appropriate validation/transfer protocols/reports, template protocols and SOPs, and working with QC and Mfg to execute.
  • Identify, evaluate, develop, validate, and implement method improvements and new analytical technologies to support clinical and commercial programs. Work with the vender and AIV to purchase and validate new instruments/software, establish instrument and method SOPs/Work instructions, training curricula and LIMS with data integrity and part 11 compliance.
  • Lead and support troubleshooting OOS, AR, and invalid assays.
  • Lead matrix teams, track progress of projects, communicate updates to leadership.
  • Contribute to regulatory filings, analytical methods and validation sections. Respond to regulatory questions. Provide technical support for analytical method validation and transfer during regulatory inspections.
  • Analyze data from wet lab and in silico experiments, develop reports to communicate results.
  • Work collaboratively with cross-functional teams. Track project deliverables and project weekly and monthly progress reports to management.

Who YouAre

You are a highly motivated experiencedAnalytical Technology Scientist with the motivation and ambition to grow in an exciting role. You work wellcollaboratively withcross-functional teams on project deliverables.

Qualifications

Required Skills
  • Bachelors, Masters, or PhD in Chemistry, Biochemistry, Biological Sciences or related field.
  • 2-10 years industry experience, depending on education
  • Technical expertise in assay, impurity analysis for small molecules, ASOs and large molecules such as HPLC, HPLC-MS, UV-VIS, pH and other technologies
  • Knowledge of stability indicating attributes for small molecule, ASOs and large molecule products
  • Relevant experience in analytical method development and validation
  • Demonstrated application and knowledge of ICH guidelines on analytical method validation
  • Statistical experimental design and data analysis with Excel and JMP software
  • Ability to think independently and work with limited oversight
  • Quickly develop and utilize internal and external professional matrix
  • Excellent oral and written communication skills
  • Excellent time management and prioritization skills
  • Experience in training and mentoring others

Preferred Skills
  • Experience working in a cGMP or regulated laboratory




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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