Full-Time

Development Program and Operations Manager

Posted on 5/23/2024

BigHat Biosciences

BigHat Biosciences

51-200 employees

Develops advanced antibody therapeutics using AI

AI & Machine Learning
Data & Analytics

Senior

San Mateo, CA, USA

Required Skills
Communications
Data Analysis
Requirements
  • Bachelor’s, Master’s, or Ph.D. degree in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Chemical Engineering, Biotechnology)
  • Five or more years of experience managing CMC activities within the biotech or pharmaceutical industry, with a focus on biologics
  • Understanding of cGMP CMC principles and processes, including process development, analytical characterization, and manufacturing
  • Experience managing tech transfer of CMC manufacturing and/or analytics
  • Excellent communication, organizational, and leadership skills
  • Ability to work effectively in a fast-paced, entrepreneurial environment and adapt to changing priorities
  • Experience with biologics drug development, including monoclonal antibodies, and/or recombinant proteins
  • [Preferred] Familiarity with regulatory requirements for cGMP, CMC development, including FDA, EMA and ICH guidelines
  • [Preferred] Familiarity with discovery stage processes and experience with program management of early discovery projects
Responsibilities
  • Provide PM support to early-stage research programs
  • Organize and coordinate cross-functional discovery stage project teams
  • Organize and manage CMC project teams
  • Organize and manage project teams conducting outsourced studies
  • Coordinate activities between key development functions
  • Collaborate closely with internal teams and external partners
  • Facilitate program decisions
  • Act as a liaison between internal teams and external partners/vendors
  • Support and track the preparation of regulatory submissions
  • Identify potential risks and challenges related to CMC development
  • Build and maintain internal CMC/GMP systems and business processes
  • Define roles and responsibilities of key staff positions
  • Identify, propose, and support solutions for organizational and operational challenges
  • Lead initiatives to optimize development team culture and staff development
  • Ensure compliance with regulatory requirements and industry standards
  • Prepare regular progress reports and presentations
  • Develop and maintain a structure for accurate and comprehensive organization of CMC documents
  • Maintain records of relevant communications within internal project teams and with external CDMOs

BigHat Biosciences, renowned for its integration of machine learning and synthetic biology, focuses on developing sophisticated antibody therapeutics. By harmonizing AI with a rapid-response wet lab, they accelerate the engineering process, enhancing potential treatment effectiveness and safety for complex diseases. This collaborative environment fosters a culture of innovation, making it an appealing workplace for those passionate about cutting-edge science and impactful healthcare solutions.

Company Stage

Series B

Total Funding

$99.4M

Headquarters

San Mateo, California

Founded

2019

Growth & Insights
Headcount

6 month growth

11%

1 year growth

21%

2 year growth

122%