Director, Drug Substance and Early Development
Abata TherapeuticsSalary not specified
Full Time
Senior (5 to 8 years)
[Remote] Associate Director, Drug Substance at Amylyx Pharmaceuticals
Cambridge, Massachusetts, United States
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
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
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the location or work arrangement for this role?
This information is not specified in the job description.
What is the salary or compensation for the Associate Director, Drug Substance position?
This information is not specified in the job description.
What qualifications are required for this role?
A Bachelor’s degree in organic chemistry, chemical engineering, or related field is required, with an MS preferred. A solid understanding of small molecules is also needed.
What is the company culture like at Amylyx Pharmaceuticals?
Amylyx fosters a culture of caring powered by core values: be audacious, be curious, be authentic, be engaged, and be accountable.
What makes a strong candidate for this position?
Strong candidates will have a Bachelor’s or MS in organic chemistry, chemical engineering, or related field, along with expertise in CMC drug substance process development for peptides and oligonucleotides, experience with CDMOs, and the ability to lead phase-appropriate activities through NDA.
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