Director/Sr. Director, Analytical Development/Quality Control

19 hours ago

South San Francisco, California, United States Terremoto Biosciences Full time

Position Summary
Terremoto Biosciences is located in South San Francisco and is seeking a Director/Sr. Director of Analytical Development/Quality Control within the Technical Operations team. Reporting to the Head of Technical Operations, the incumbent will be required to work flexibly across multiple small molecule programs with responsibilities including but not limited to managing all internal/external analytical development activities across various stages of development, overseeing analytical and QC activities at trusted CDMO partners and contract testing labs, ensuring compliance with regulatory standards, and working cross-functionally with key stakeholders.

Key Responsibilities

  • Act as the analytical technical lead for multiple small molecule programs
  • Provide technical leadership while working with cross-functional team members
  • Develop strategies and oversee the execution of analytical activities associated with both drug substance and drug product development and manufacturing, supporting clinical development, and regulatory filings
  • Lead phase appropriate analytical method development and transfer, qualification and validation activities, in-process/release/stability testing, setting of specifications, product characterization, and quality control activities
  • Foster and contribute to a team culture of scientific rigor, accountability, and inclusivity through the management/mentorship of internal FTEs and supporting professional development
  • Effectively communicate progress (reports and presentations) regarding all drug substance/product related activities to key stakeholders both internally and externally
  • Author, review, and/or approve development/stability reports, specifications, controlled documents, standard operating procedures, deviation/investigation reports, and required sections of regulatory submissions
  • Travel to CDMOs for vendor assessment, troubleshooting, qualification, and/or analytical testing oversight as needed

Qualifications

  • Ph.D. in Analytical Chemistry or related field with 8+ years of experience in the pharmaceutical/biotech industry with a strong track record of technical expertise, leadership, and analytical development and quality control experience across various stages of development with small molecules
  • Extensive experience with the management of CDMOs and contract testing labs
  • Thorough understanding and working experience of pharmaceutical drug substance and drug products concerning cGMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements
  • Strong understanding of drug development process from preclinical through late-stage development
  • Strong organizational and leadership skills with the ability to effectively manage multiple priorities and clearly communicate results both written and verbally
  • The anticipated salary range for candidates who will work in South San Francisco, CA is $235,000 to $260,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Terremoto Biosciences, is a multi-state employer and this salary range may not reflect positions that work only in other states.

We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

  • Associate Director/Director, Analytical Development

    2 days ago

    South San Francisco, California, United States Septerna Full time $185,000 - $240,000

    Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company's Native Complex Platform recapitulates GPCRs with their native structure, function, and dynamics outside...

  • Associate Director, Analytical Development and Quality Control

    3 days ago

    San Diego, California, United States Kailera Therapeutics, Inc. Full time $160,000 - $200,000

    At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions.  We...

  • Director, People Analytics

    2 weeks ago

    San Francisco, California, United States Crusoe Full time

    Crusoe's mission is to accelerate the abundance of energy and intelligence. We're crafting the engine that powers a world where people can create ambitiously with AI — without sacrificing scale, speed, or sustainability.Be a part of the AI revolution with sustainable technology at Crusoe. Here, you'll drive meaningful innovation, make a tangible impact,...

  • Sr. Director

    5 days ago

    San Francisco, California, United States KayeBassman International Full time

    Kaye/Bassman International is a leading executive search firm that has been filling roles for Pharma and Biotech clients for over 35 years. Our Medical Affairs search practice is led by Michael Pietrack, a leading Medical Affairs recruiter and the host of The Pharmaverse Podcast.In this short video, Michael introduces the role.Senior Director - Health...

  • Sr. Director, Technical Program Management

    5 days ago

    San Francisco, California, United States Capital One Full time

    Sr. Director, Technical Program Management (AI/ML)Are you interested in leading programs that deliver on critical business goals and build large scale products & platforms?About Capital One -  At Capital One, we're changing banking for good. We were founded on the belief that no one should be locked out of the financial system. We're dedicated to helping...

  • Sr. Director, Clinical Operations

    7 days ago

    South San Francisco, California, United States ALX Oncology Inc. Full time

    POSITION SUMMARY:ALX Oncology seeks a dynamic leader with a proven track record of success in Clinical Operations. Reporting to the Vice President, Clinical Operations, the Sr. Director, Clinical Operations will guide the clinical team to achieve all milestones and deliverables from protocol creation to study completion. The candidate will actively...

  • Senior Director, Product Analytics

    3 days ago

    San Jose, California, United States McAfee Full time

    Job TitleSenior Director, Product AnalyticsRole OverviewWe're seeking a strategic Product Analytics leader to build and scale our understanding of how customers engage with McAfee's suite of online protection tools. The role will reporting into the VP, Analytics & Data Science, and lead a team of product analysts and data scientists embedded across our...

  • Director, Analytical R

    2 days ago

    South San Francisco, California, United States Merck Full time $210,000 - $330,500

    Job DescriptionThe Director of Discovery Analytical Research provides strategic and technical leadership at the discovery-development interface, enabling the identification and advancement of new drug candidates, including proteins, monoclonal antibodies, ADCs, and small molecules. This role oversees the development and implementation of advanced analytical...

  • Sr. Director, Investor Relations

    2 weeks ago

    San Francisco, California, United States Gilead Sciences Full time

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our...

  • Sr. Sales Director

    3 days ago

    San Francisco, California, United States Jobs via Dice Full time

    Dice is the leading career destination for tech experts at every stage of their careers. Our client, TRUGlobal, is seeking the following. Apply via Dice todayIndustry IT Services (Cloud, Infra, AI/Analytics, ERP, CRM, Security, Digital)Key Responsibilities:Expand accounts through upselling, cross -selling, and strategic growth programs.Build strong CXO/VP...