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Head, Analytical Development & QC

Company: Amylyx Pharmaceuticals
Location: Cambridge
Posted on: January 26, 2023

Job Description:

With recent approvals in the US and Canada Amylyx Pharmaceuticals is launching a new drug for the treatment of adults with ALS.
If you are looking for a place where your work can have a deeper impact than you ever imagined and where you can be true to yourself - Amylyx is the place for you!
At Amylyx, we're bringing together talented people like you who are committed to solving for humanity's most devastating diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer's disease, and others-all in a uniquely supportive, respectful environment that rewards innovative thinking, committed teamwork, and boundless curiosity.
Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences-in all the best ways.
We provide a competitive employee benefits package including stock options and RSUs; flexible work options including hybrid and remote; discretionary time-off; comprehensive healthcare, including dental and vision coverage; and retirement savings benefits.POSITION SUMMARY
Provide the vision, direction for and lead Amylyx Analytical Development and QC through the development, validation, implementation, optimization and technology transfer of analytical and process control methodologies. Responsible for compliance advancement of development programs for small molecules, sterile injectables, ASOs, LMPs, and oral formulations, global data trending, global reference standard management, CMC submissions, specification settings, OOS/OOT investigations, and oversight of contract testing laboratories.
RESPONSIBILITIES


  • Drive strategic decisions to identify and implement those tests needed to fully characterize the physical and chemical properties of pharmaceutical drug products based on guidelines to assure successful regulatory submissions and robust analytical services.
  • Conduct research to develop or improve analytical techniques, methodology, procedures, and investigate the application of instruments in analysis.
  • Responsible for the development and execution of analytical development strategies supporting the analytical activities and controls for drug products and finish drug products by working with cross-functional development teams and external development organizations.
  • Provide guidance and direction to analytical development programs of Amylyx external contract organizations (CMO/CTL) and partners. Responsible for bringing analytical representation and expertise for small molecules, oral formulations, ASOs, LMPs and injectables to project teams.
  • Develop analytical strategies in support of pharmaceutical drug products during all development phases (Phase I-Phase IV), including supporting manufacturing process development; developing, validating and transferring analytical methods; designing stability studies to understand drug degradation mechanisms and for shelf-life assignments; and developing impurity control strategies
  • Responsible for global data trending of release and stability data, OOS/OOT investigations, reference standards and markers management. Assure availability and characterization of analytical materials such as standards and markers at all times.
  • Oversee establishment and maintenance of global clinical and commercial specification settings for release and stability.
  • Manage and author analytical / QC portions of Annual Product Quality Reviews (APQRs)
  • Responsible for the review of analytical method validation protocols/reports and oversees the execution of the work at external labs.
  • Lead and/or oversee transfers of analytical methods.
  • Critically review and interpret scientific data to derive clear conclusions and provide direction for future work.
  • Author relevant sections of the quality modules of regulatory submissions. Responds to Health Authorities questions during review of global marketing application.
  • Prepare and participate in meetings with global regulatory authorities to promote understanding of Identity, Impurity and Assay control strategies and specification settings.
  • Sets a high compliance standard and ensures that systems and resources are in place to ensure the activities of analytical development laboratories and QC are conducted in compliance with cGMP/GLPs (as needed), SOPs, policies, good documentation practices, and pharmaceutical guidance
  • Facilitate teamwork and coordinate execution of plans with key stakeholders
  • Identifies department needs and recruits, hires and promotes personnel as appropriate
  • Shares responsibility for the department budget and forecast; including external contract testing expenses, and personnel requirements

    REQUIREMENTS

    • MS or Ph.D. in scientific discipline with 10 or more years of experience in drug development process and/or QC; or equivalent
    • Scientific knowledge and experience in analytical and/or pharmaceutical chemistry in drug and product development and associated analytical/QC requirements throughout the discovery, development, commercial, and post-approval continuum
    • Experience with leading QC team, managing data trending, specification settings and OOS/OOT investigations
    • Working knowledge of writing/reviewing of APQRs and relevant sections of clinical and commercial regulatory submissions e.g. IND, IMPD, NDA, MAA, etc.
    • Thorough knowledge of cGMP/GLPs , ICH, FDA, USP, CFRs and other pharmaceutical industry regulatory guidelines
    • Demonstrate a strong understanding of GMP Controls, regulatory and CMC requirements. Thorough understanding of the regulatory requirements in CMC development
    • Mastery of regulatory requirements for job and extended group functions, expertise with regulatory requirements for pharmaceutical drug development and QC
    • Possess enhanced technical skills and command of analytical laboratory instrumentation and equipment
    • Demonstrated skills in leading projects with an assigned team
    • Demonstrated competence in the design and documentation of complex experiments focused on a specific topic
    • Expertise in the logical design of analytical, pharmaceutics and/or validation experiments
    • Expertise with GxP documentation requirements
    • Demonstrated ability to effectively communicate ideas and information, both in oral and written form
    • Readily serve as a technical subject matter expert on various analytical and QC aspects
    • Travel (including international) may be required (approximately 25%)

      COVID-19 Vaccination Policy: Candidates should be aware that Amylyx's current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.
      To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.
      To return to our website please click here.
      Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Keywords: Amylyx Pharmaceuticals, Cambridge , Head, Analytical Development & QC, Other , Cambridge, Massachusetts

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