Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 4 days ago

Director, Manufacturing Sciences and Technology (MSAT)

Amylyx Pharmaceuticals35 open roles

Pay
$209,000 – $235,000 a year
Where
Cambridge, MA
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowDirector, Manufacturing Sciences and Technology (MSAT)Amylyx Pharmaceuticals · Cambridge, MA

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Amylyx Pharmaceuticals's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

8.0% of postings close within 7 days. Measured by our own scanner across the market. Amylyx Pharmaceuticals postings stay open a median of 34 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.5%3 days
  3. 8.0%7 days
  4. 14.9%14 days
  5. 34.1%30 days
This job: posted 4 days ago

Amylyx Pharmaceuticals median: 34 days open

The posting

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Opportunity

Amylyx is seeking a Director, Manufacturing Sciences and Technology to establish and lead MSAT capabilities as the company prepares for commercialization. This leader will serve as the technical owner for outsourced drug substance and drug product manufacturing, with accountability for process robustness, scalability, process validation, continued process verification, and lifecycle management in close partnership with External Manufacturing, Quality, Regulatory CMC, Supply Chain, and manufacturing partners.

The ideal candidate will bring strong MSAT experience with the ability to operate both strategically and hands-on in a small, fast-moving biotech environment that relies heavily on external manufacturing partners. This leader will have demonstrated success leading technology transfers, process validation, manufacturing support, and operational excellence through influence and cross-functional partnership. This role reports to the Senior Vice President, CMC and External Manufacturing.

Responsibilities

MSAT Strategy & Technical Leadership:

  • Lead and develop a high performing MSAT team establishing robust technical transfer, process qualification, and process control processes.
  • Act as a technical subject matter expert when needed while leading and coaching team members across technology transfer, manufacturing support, and troubleshooting to drive operational excellence.
  • Establish the global MSAT strategy and provide technical leadership across late-stage development, process validation, commercial manufacturing, continued process verification, and lifecycle management.
  • Provide technical leadership for CDMO evaluation, onboarding, technology transfer, validation, commercial manufacturing campaigns, process performance monitoring, troubleshooting, and lifecycle changes across drug substance and drug product manufacturing.
  • Partner with External Manufacturing and Quality leadership to resolve technical, process, and performance issues.
  • Proactively identify critical path activities, technical risks, resource needs, and budget implications; develop practical mitigation plans and contingency strategies in collaboration with internal and external teams.
  • Travel to global manufacturing and development sites as needed to support technical transfers, GMP campaigns, and troubleshooting.

Process Validation & Manufacturing Performance

  • Establish and oversee process qualification policies, procedures, templates, and governance practices that enable consistent PPQ execution, continued process verification, technical risk management, and commercial manufacturing readiness across Amylyx and its external manufacturing network.
  • Ensure manufacturing processes are operationally robust, scalable, and continuously improved to support reliable supply, product quality, patient needs, and business growth.
  • Lead MSAT readiness for process validation, PPQ, commercial launch, and ongoing process monitoring, ensuring process knowledge, manufacturing documentation, sampling plans, comparability strategies, and continued process verification approaches are fit for purpose.
  • Provide technical guidance for process troubleshooting, deviation investigations, root-cause analyses, CAPAs, change controls, process performance trending, and technical impact assessments in collaboration with Quality and external partners to support validation, launch, and commercial supply.
  • Review and approve CDMO technical documents, including protocols, batch records, campaign plans, development reports, deviation assessments, technical memos, and manufacturing documentation.

Regulatory:

  • Partner with the CMC team to author, review, and defend technical content for CMC regulatory filings, agency questions, and briefing materials.
  • Accountable for regulatory submission content and comparability strategy for new manufacturing sites, scale-ups, process improvements and changes.

People Management:

  • Lead, mentor, and develop internal technical MSAT team members fostering scientific rigor, accountability, collaboration, urgency, and pragmatic decision-making. Provide career development guidance, coaching, performance feedback, and succession planning for team members. Allocate resources effectively across programs and ensure MSAT priorities are aligned with organizational objectives, program milestones, commercial readiness needs, and available capacity. Build scalable MSAT processes, templates, technical governance routines, knowledge-management practices, and best practices appropriate for a growing biotech organization operating through external partners. Promote technical excellence through coaching, training, knowledge sharing, and transparent communication across internal teams and CDMO partners.

Requirements

  • BA with 10 years’ experience, or MS with 8+ years’ experience in Chemical Engineering, Biological Sciences, Pharmaceutical Sciences, or related discipline.
  • Experience with drug substance and drug product manufacturing technologies relevant to peptides, proteins, oligonucleotides, small molecules, or other complex modalities, with the ability to translate process knowledge into practical manufacturing controls.
  • Deep expertise in Quality by Design (QbD), with advanced knowledge of cGMP expectations and relevant FDA, EMA, ICH, and other global CMC guidance and regulatory requirements.
  • Proven ability to operate independently, influence without direct authority, make sound technical decisions under ambiguity, and build trusted relationships with internal stakeholders and external partners.
  • Excellent leadership, communication, collaboration, technical writing, and executive-level presentation skills.
  • Strategic thinker with the discipline and execution focus to translate vision into operational results. Skilled at leading through influence, particularly in remote and matrixed environments.
  • High standards of quality, accountability, and urgency with the resilience to thrive in a fast-paced environment.
  • Collaborative, team-oriented approach balanced with the decisiveness required of a technical leader.
  • Ability to travel domestically and internationally up to 10%, with additional travel as business needs require.

Work Location and Conditions:

  • At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations candidates must be able to attend meetings at our office in Cambridge, MA on a regular basis. Preference will be given to candidates who reside in the New England region and can be in person on an as needed basis.
  • When working remotly, you must have access to a work setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

Compensation

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.

Estimated Pay Range

$209,000—$235,000 USD

To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.

To return to our website please click here.

Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. 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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Amylyx Pharmaceuticals's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Amylyx Pharmaceuticals's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Amylyx Pharmaceuticals's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.