Head, Analytical Development & QC
Company: Amylyx Pharmaceuticals
Posted on: January 26, 2023
With recent approvals in the US and Canada Amylyx
Pharmaceuticals is launching a new drug for the treatment of adults
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
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
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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- MS or Ph.D. in scientific discipline with 10 or more years of
experience in drug development process and/or QC; or
- 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
- 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
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.
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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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