Full-Time

Senior Director

Quality Operations

Confirmed live in the last 24 hours

Alector

Alector

201-500 employees

Develops therapies for neurodegenerative diseases

Biotechnology
Healthcare

Compensation Overview

$236k - $256kAnnually

Senior

San Bruno, CA, USA

Hybrid position based in South San Francisco, CA.

Category
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • Bachelor's degree in biological sciences or related field with 12+ years in pharmaceuticals, including 6+ years in Quality. Advanced degree preferred.
  • 6+ years' experience with biological products, especially recombinant proteins or monoclonal antibodies, and knowledge of upstream/downstream processes and aseptic filling.
  • Experience leading and developing a team of quality professionals.
  • In-depth knowledge of method development, validation, and testing for Biologicals.
  • Strong understanding of US and international GMPs (e.g., ICH Q1 – Q12) for late-stage clinical and commercial environments.
  • Proficient in Quality Risk Management, data integrity, and validation concepts.
  • Knowledge of cell banking operations.
  • Basic understanding of Clinical Quality principles.
  • Experience with GMP inspections by FDA and other Health Authorities.
  • Effective communication and decision-making skills in Quality.
  • Strong interpersonal skills for cross-functional and cross-company teamwork.
  • Ability to multi-task and prioritize systematically.
Responsibilities
  • Lead a team of Quality professionals to establish an effective Quality Operations department in a fast-paced, late-stage biotech company.
  • Oversee global product disposition of drug substances, products, and clinical kits, coordinating with Qualified Persons in Europe and other regions for timely release.
  • Manage Quality Events (Deviations, CAPAs, Change Control, Complaints).
  • Provide Quality production oversight across the supply chain, coordinating with CMOs and internal collaborators, and prioritize external audits with the Quality Systems and Compliance team.
  • Oversee analytical method development, validation, specification setting, and stability programs.
  • Participate in Quality System and SOP development for Quality operations.
  • Engage in internal Quality activities such as audits, inspection readiness, and electronic system implementation.
  • Perform additional tasks as directed by the VP of Quality.
  • Collaborate with internal Quality teams (Clinical Quality, Quality Systems) and external Quality teams at CMOs or partner companies.
  • Work closely with internal partners, including Operations teams and Regulatory Affairs.

Alector develops therapies aimed at treating neurodegenerative diseases like Alzheimer's and Parkinson's. The company focuses on research and development of new drug candidates by utilizing knowledge from immunology, neurology, and human genetics. Their approach involves conducting early-stage clinical trials to gather specific data about diseases, which helps improve the chances of success for their treatments. Alector differentiates itself from competitors by emphasizing the body's natural healing processes in their drug development. The company's goal is to create effective treatments for conditions that currently have limited options, thereby addressing significant medical needs in the healthcare sector.

Company Stage

IPO

Total Funding

$189.2M

Headquarters

San Francisco, California

Founded

2013

Growth & Insights
Headcount

6 month growth

0%

1 year growth

1%

2 year growth

-8%
Simplify Jobs

Simplify's Take

What believers are saying

  • The recent $75 million financing round strengthens Alector's financial position, enabling further R&D efforts.
  • FDA Breakthrough Designation for latozinemab, developed in collaboration with GSK, highlights the potential impact of their therapies.
  • The appointment of experienced leaders from companies like Genentech and Kura Oncology bolsters Alector's executive team, enhancing strategic direction and operational execution.

What critics are saying

  • The biopharmaceutical industry is highly competitive and capital-intensive, requiring continuous investment to sustain R&D efforts.
  • Dependence on successful clinical trial outcomes and regulatory approvals poses significant risks to the commercialization of their therapies.

What makes Alector unique

  • Alector leverages a unique combination of immunology, neurology, and genetics to develop therapies, setting it apart from competitors who may focus on just one of these areas.
  • Their strategic partnerships with major pharmaceutical companies like GSK and AbbVie enhance their R&D capabilities and accelerate the commercialization of their therapies.
  • Alector's focus on early-stage clinical trials and rapid data collection increases the probability of success for their therapeutic candidates.

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