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Director, CMC Analytical

Employer
Maze Therapeutics
Location
South San Francisco, CA
Start date
Mar 28, 2024

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Job Details

The Position:

Join us at Maze Therapeutics as our Director of CMC Analytical and become a pivotal part of our Technical Operations leadership team.  You will be at the forefront of crafting and executing analytical strategies for our early-phase small molecule programs, driving us closer to our goals.  Your role will involve owning both internal and external analytical method development and validation, as well as setting up product specifications and overseeing QC testing at the CMOs.  You’ll report to the VP of Technical Operations and collaborate closely with the CMC team to ensure we are hitting our Maze objectives.  It’s an exciting opportunity to make a real impact on multiple programs at Maze with the intent of improving patient lives.

Your Impact:

  • Develop and implement a comprehensive forward-thinking analytical development strategy that aligns with our corporate vision.
  • Lead the design of phase appropriate specifications for drug substance (DS) and drug product (DP) manufacturing, crucial for regulatory filings.
  • Provide oversight for a range of analytical activities conducted at third party labs including structure elucidation, method development and validation, stability studies, method transfer, testing of clinical materials and qualification and maintenance of reference standards.
  • Review and approve CMO’s analytical documents such as analytical methods, method validation protocols and reports, stability protocols and reports, specifications, change controls, and deviations/investigations.
  • Evaluate potential CMOs by assessing their analytical capabilities.
  • Manage the internal method development and stability studies as well as internal analytical lab work to support the internal DS and DP development.
  • Collaborate closely with Quality Assurance (QA) to establish SOPs for analytical related processes, promoting efficiency and consistency.
  • Contribute to regulatory filings by authoring and reviewing relevant CMC sections.
  • Foster clear communication channels with both line management and the broader CMC team.

As a Director, we also expect our leaders to demonstrate the following Leadership Competencies:

  • Communication and Influence
    • Builds communication channels across Maze for sharing information
    • Influences Senior Management decisions through persuasive arguments
    • Respectfully addresses differing opinions leading to support of decision
  • Teamwork and Collaboration
    • Champions partnerships and connections across Maze
    • Proactively addresses issues that could result in breakdown of team relationships
    • Spotlights team and individual contributions in public forums
  • Execution and Results
    • Addresses gaps and leverages strengths to get best results
    • Maintains a steadying presence and clarifies priorities during change
    • Anticipates and removes barriers that put functional/corporate goals at risk
  • Develop Others and Self
    • Removes barriers to staff development and empowers them to make their own decisions
    • Stays current on industry trends and keeps direct-reports prepared and responsive

Skills and Qualifications:

  • An advanced degree in Chemistry or related field; a PhD is preferred.
  • 12 or more years of experience in small molecule analytical work within the pharmaceutical industry
  • Thorough understanding of cGMPs, ISO, and ICH guidelines, and industry best practices
  • Demonstrated leadership abilities honed through previous roles, driving teams toward success.
  • Possesses an understanding of Design of Experiments (DOE) and Quality by Design (QbD) principles.
  • Effectively communicates across all levels and functions, with exceptional verbal and written skills.
  • Embraces a collaborative mindset, valuing diverse perspectives and teamwork.
  • Employment of robust project management skills is a plus.
  • Willingness to travel as needed to ensure realization of our CMC goals through external partners.

 

About Maze Therapeutics

Maze Therapeutics is a biopharmaceutical company that is harnessing the power of human genetics to transform the lives of patients, with a focus on genetically informed therapies for common diseases, such as chronic kidney disease, . and seeks to focus expertise and resources towards underserved communities. Maze applies variant functionalization in tandem with advanced data science methods and a robust suite of research and development capabilities to advance a pipeline of novel precision medicines. Maze has developed the Maze Compass Platform™, a proprietary, purpose-built platform to understand and integrate the critical step of variant functionalization into each stage of drug development. Utilizing the Maze Compass Platform™, Maze is building a broad portfolio of wholly owned and partnered programs. Its two lead programs are focused in Chronic Kidney Disease (CKD), a condition that impacts an estimated 37m individuals. The first program in CKD addresses a genetic subset of the common disease that has a disproportionate impact on the Black Community. Maze is based in South San Francisco.

Our People

Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. 

Our Core Values

Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission. 

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

Stand True – Our integrity is foundational; it guides us no matter the obstacle.

The expected annual salary range for employees located in the San Francisco Bay Area is $207,000 - $253,000. Additionally, this position is eligible for an annual performance bonus.

Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.

Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.

Company

Maze Therapeutics is translating novel genetic insights into lifesaving medicines, through an approach that integrates human genetics and functional genomics. Advances in these areas have enabled us to decode the mysteries of genetic modifiers in a range of severe diseases, which we aim to turn into medicines that mimic protective mutations. 
 
What are genetic modifiers?
 
Despite an understanding of the genetic basis for many diseases, it remains a mystery why some people with a disease-causing mutation never get sick. This is often due to genes elsewhere in our DNA that affect the severity of disease and can provide a natural form of protection.
 
The Maze approach
 
Dramatic advances in human genetics and functional genomics now enable us to decode the mysteries of genetic modifiers in a range of severe diseases. Today, we believe we can systematically identify genetic modifiers and turn these insights into medicines. We have assembled a world-class team to realize this vision, including creative scientific pioneers, experienced company builders and biotech industry leaders.
 
Join us in our pursuit to change lives by translating genetic insights into medicine - view our job postings with the link to the left.

Company info
Website
Location
171 Oyster Point Blvd, Suite 200
South San Francisco
CA
94080
US

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