[Remote] Associate Director, Drug Substance at Amylyx Pharmaceuticals

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

Bachelor’s degree in organic chemistry, chemical engineering, or related field. MS preferred
A solid understanding of small molecule, RNA, and amino acid chemistries
At least 5 years of experience in API process development from early through late-phase. Prior process validation experience preferred
Experience developing oligonucleotide and/or synthetic peptide manufacturing processes including impurity control strategies
Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents
A strong track record of successful global CMC submissions and approvals
Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, phase appropriate, risk-management based solutions to complex technical challenges
Experience working with contract manufacturing organizations
Excellent communication and teamwork skills
Ability to travel internationally up to 10%

Responsibilities

Lead CMC drug substance phase appropriate process development activities from Phase 1 through NDA ensuring Module 3 content supports global clinical filings and registration plans
Serve as the technical SME and process owner for drug substance. Working with contract manufacturing organizations, develop scalable and robust manufacturing processes for oligonucleotides and peptide products
Evaluate new CDMOs to support tox and clinical material needs. Serve as the technical SME on all DS tech transfer projects
Monitor drug substance GMP operations including clinical batch record review, and process data trending and support of related quality events
Author IND and NDA Module 3, Master Batch Records, Validation Plans and Reports
Understand regulatory plans for all proposed changes, minimizing risk to product supply
Foster effective teamwork and drive project execution. Proactively track critical path activities, anticipate risks, create contingency plans and decision-making exercises in collaboration with project teams
Provide input to project timelines and budgets and communicate progress
Regularly interacts with key CMC team members including Regulatory, Quality, Analytical Development, Supply Chain, and External Manufacturing
Travel to global manufacturing sites to support operations and validation activities

Skills

Amylyx Pharmaceuticals

Develops treatments for neurodegenerative diseases

About Amylyx Pharmaceuticals

Amylyx Pharmaceuticals develops treatments for neurodegenerative diseases, focusing on conditions like Amyotrophic Lateral Sclerosis (ALS) and Alzheimer's Disease (ALZ). Their main product, AMX0035, is currently undergoing clinical trials to assess its effectiveness. The CENTAUR ALS trial showed promising results for ALS patients, using a randomized, double-blind, placebo-controlled design to ensure reliable outcomes. They are also conducting the PEGASUS trial to evaluate AMX0035's safety and effectiveness in Alzheimer's patients. Unlike many competitors, Amylyx emphasizes community engagement and awareness campaigns, such as ALS Awareness Month, to educate the public and foster support for those affected by these diseases. The company's goal is to bring effective therapies to market that improve patient outcomes and enhance the quality of life for individuals suffering from neurodegenerative conditions.

Cambridge, MassachusettsHeadquarters

2013Year Founded

$166.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Remote Work Options

Risks

Relyvrio's Phase III failure raises concerns about ALS treatment efficacy.

Low stock offering price suggests potential financial instability.

New CCO may disrupt commercialization strategies if not aligned with goals.

Differentiation

Amylyx focuses on neurodegenerative diseases like ALS and Alzheimer's.

AMX0035 is a promising drug for ALS and Alzheimer's treatment.

Amylyx engages in community awareness campaigns for neurodegenerative diseases.

Upsides

Positive Phase II results for AMX0035 in ALS boost its potential.

Partnership with Gubra accelerates drug development for neurodegenerative diseases.

Regulatory support for rare diseases aids Amylyx's Wolfram syndrome efforts.

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