Full-Time

Associate Director / Director

CMC, Chemistry, Manufacturing, And Controls

Posted on 7/10/2024

Mammoth Biosciences

Mammoth Biosciences

51-200 employees

Develops CRISPR-based diagnostic tests

Biotechnology
Healthcare

Compensation Overview

$163.5k - $220kAnnually

Senior, Expert

Daly City, CA, USA

The position is onsite.

Category
Bioinformatics
Genomics
Biology Lab & Research
Biology & Biotech

You match the following Mammoth Biosciences's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
Requirements
  • Master’s Degree in a relevant scientific discipline
  • Prior experience with CMC development in Gene therapy is highly desired
  • Minimum of 10 years experience in biotech in large and small molecules (Director); minimum of 8 years experience (Associate Director)
  • Strong process understanding in one or some of: biologics, oligonucleotide, cell therapy, viral vectors, gene therapy or LNP
  • Experience in management of external CDMOs for DS/DP production
  • Strong understand of phase appropriate analytical development and manufacturing strategies for large and small molecules
  • Experience with US and EU CMC regulatory expectations, technical transfers, and complex development & manufacturing activities
  • Excellent people manager and cross-functional leader, able to lead diverse and complex teams with demonstrated success
  • Ability to travel both domestically and internationally, as needed
Responsibilities
  • Responsible for the design, development, phase appropriate qualification and verification/validation of the analytical methodologies for Mammoth’s pipeline
  • Identify opportunities to improve productivity and efficiency in projects and analytical science
  • Responsible for working as an integral part of diverse teams including CDMO analytical science teams
  • Lead the analytical science in project teams ensuring project alignment and fostering productive relationships with other core functions across the organization
  • Ensure data integrity and foster an environment of knowledge sharing throughout the medicine development lifecycle process
  • Ensure compliance with regulatory standards including GMP, ICH, EMA and FDA guidelines
  • Support the preparation of global regulatory submissions, scientific reports and patents
  • Develop phase‐appropriate quality control strategies for drug substance and drug product
  • Manage the drug substance and drug product stability study programs
  • Lead development of scientifically sound and data driven specifications
  • Oversee analytical and QC activities at CDMOs and Contracting Testing Laboratories, including the review and approval of test records, forms, methods, protocols and reports
  • Identification and development of suitable analytical methods to allow comprehensive characterization of both the quantitative and qualitative attributes of drug substance and drug product, associated impurities and excipients
  • Ensure documentation is maintained within the quality management system
  • Provide broad CMC support for internal programs from GLP tox through IND clinical programs
  • Ensure timely Drug Substance/Drug Product supply for non-clinical and clinical studies
  • Assist in the preparation and review of CMC sections of regulatory submissions, including IND, BLA, NDA, and MAA
  • Lead management of CMOs for process development and manufacturing of Drug Substances and Drug Products for toxicology and cGMP supplies
  • Develop and execute CMC strategies for early phase as well as late phase Drug Substance/Drug Product clinical supplies
  • Responsible for phase appropriate development and practical implementation of processes and controls for regulatory materials, intermediates, and drug substances and drug products
  • Coordinate with internal and external analytical/quality control, quality assurance, and regulatory team members to resolve technical issues or deviations during cGMP production
  • Create and manage contracts, requests for pricing, supply agreements, etc., related to drug substance and drug product manufacturing
  • Ensure activities are executed in alignment with established Quality Agreements. Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings as needed
  • Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs and suppliers
  • Develop and maintain collaborative relationships with internal stakeholders (e.g., Discovery, Non-Clinical, CMC, Clinical Operations, Regulatory, Quality, Finance, etc.) to deliver on internal goals and objectives
Desired Qualifications
  • Previous experience with CMC development in gene therapy
  • Previous experience managing CDMOs for outsourced manufacturing
  • Extensive understanding of cGMP regulations
  • Previous experience working in small to midsize biotech
  • Previous experience in CMC development of Gene Therapy products
  • Previous experience in small molecule and biologics manufacturing
  • Previous experience in formulation development for complex products like lipid nanoparticles
  • Experience with various cultures, as CDMOs are global, with potential for global travel

Mammoth Biosciences focuses on molecular diagnostics using CRISPR technology to develop tests that quickly and accurately identify ailments, including infectious diseases like COVID-19, at the point of care. This allows for immediate results, reducing delays associated with traditional lab tests. The company differentiates itself with its versatile CRISPR-based detection platform, which offers a wide range of testing applications. Mammoth's goal is to enhance healthcare outcomes by making diagnostic testing more accessible and efficient.

Company Stage

Late Stage VC

Total Funding

$353.3M

Headquarters

Brisbane, California

Founded

2017

Growth & Insights
Headcount

6 month growth

1%

1 year growth

1%

2 year growth

-4%
Simplify Jobs

Simplify's Take

What believers are saying

  • Collaboration with Regeneron enhances CRISPR-based gene-editing capabilities.
  • $95 million investment from Regeneron boosts financial resources for CRISPR advancements.
  • Presentation at ASGCT highlights progress in ultracompact CRISPR systems for genetic diseases.

What critics are saying

  • Emerging competition from companies like VedaBio challenges market position.
  • Recent layoffs may indicate internal challenges or strategic shifts.
  • Regulatory hurdles could delay market entry for gene-editing therapies.

What makes Mammoth Biosciences unique

  • Mammoth Biosciences leverages novel CRISPR systems like Cas12, Cas13, and Cas14.
  • Co-founded by CRISPR pioneer Jennifer Doudna, enhancing credibility and innovation.
  • Focuses on democratizing disease detection with affordable, real-time point-of-care tests.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Medical, dental, & vision

401(k)

Unlimited vacation

Transportation subsidy

Onsite amenities

Happy hours

INACTIVE