Director/Sr. Director, Analytical Development/Quality Control

3 days 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, Analytical Development and Quality Control

    4 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, Analytical Chemistry

    4 days ago

    South San Francisco, California, United States Calico Full time $270,000 - $286,000

    Who We Are:Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico's...

  • Sr. Director

    6 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...

  • Director, Quality

    1 week ago

    San Francisco, California, United States Braveheart Bio Full time $200,000 - $293,000

    About us:Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. Our lead program is a next-generation myosin inhibitor, licensed from Hengrui Pharma, being developed to transform the treatment of hypertrophic cardiomyopathy (HCM)—the most common inherited cardiac disease.Currently in...

  • Director/Sr. Director, Patient Marketing

    1 week ago

    San Diego, California, United States Gossamer Bio Full time

    SummaryThe Director/Sr. Director, Patient Marketing, will execute marketing strategies to support the commercial success of our product portfolio. This role collaborates with cross-functional teams to drive product launches, market penetration, and brand awareness. The ideal candidate possesses deep knowledge of biotechnology and rare disease markets, with a...

  • Director, Commercial Analytics

    2 days ago

    San Francisco, California, United States BridgeBio Full time

    Mavericks WantedWhen was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks onIn 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This...

  • Associate Director

    2 weeks ago

    South San Francisco, California, United States Chryselys Full time

    Job Title : Associate Director - Commercial AnalyticsLocation:South San Francisco (Onsite)Job SummaryThe Associate Director, CommercialAnalyticswill provide integral support to commercial initiatives for pharma clients. This role develops strategic solutions for pharmaceutical clients using variety of industry specific datasets. The role will manage and lead...

  • Sr Director, External Quality Testing Operations

    1 week 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. Director of Manufacturing

    1 day ago

    San Francisco, California, United States Raizan Solutions LLC Full time

    Sr. Director, Engineering – Manufacturing & FacilitiesLocation: West Coast | Travel: Up to 50%Compensation starting from: $210, % Short-Term Bonus + 15% Private Equity Base IncentiveIndustry: Food Manufacturing / Insulation SolutionsSummaryThe Sr. Director, Engineering leads and oversees engineering operations across multiple large-scale food...

  • Sr Director, Product

    14 hours ago

    San Francisco, California, United States Autodesk Full time

    Job Requisition ID #25WD94257Senior Director, Product & Platform Central FinanceLocation:San Francisco, CA preferred given business partner location.Any US/Canada location willing to work West Coast hours consideredWork Arrangement:HybridPosition OverviewReporting to the Head of Corporate and Product Finance, the Senior Director for Product & Platform...