Director Drug Substance Development and Manufacturing

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Company

Calcilytix Therapeutics

Location

San Francisco, CA

Calcilytix Therapeutics is a clinical stage biopharmaceutical company focused on addressing disorders of calcium homeostasis at the source. Our product candidate is an orally-administered small molecule that specifically inhibits the calcium sensing receptor, hypothesized to restore normal serum calcium and lower urine calcium.

Calcilytix is a member of the BridgeBio Pharma. BridgeBio Pharma is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio pipeline of over 15 development programs includes product candidates ranging from early discovery to late-stage development.

Responsibilities

  • Oversee contract development organizations to lead development and optimization of drug substance processes to support the program from phase I clinical through commercial launch. 
  • Oversight and direction of GMP production activities at contract manufacturing organizations (CMOs) to support clinical trials.
  • Review and approve master batch records, executed batch records, manufacturing deviations and investigations.
  • Write, review and approve CMC and manufacturing process documentation for compliance with cGMP and other appropriate regulations and guidelines. Prepare technical reports in support of regulatory submissions.
  • Provide on-site technical support during on as needed basis to oversee various manufacturing/scale up/validation activities.  Provide technical expertise to trouble-shoot manufacturing/packaging process issues.
  • Generate and/or review experimental plans and lead drug substance development activities. Utilize QbD principles, such as risk assessments, where appropriate in development. 
  • Establish Drug Substance control strategy.
  • Generate and/or review Process Validation documentation, including Product Validation Master Plans, Statistical Product Sampling Plans, Cleaning Validation Plans, and Process Performance Qualification Protocols.
  • Assist in supply chain logistics for drug substance manufacturing activities.
  • Interface effectively with other disciplines (e.g., Clinical, Nonclinical, Drug Product, Quality Assurance, Analytical Development and Quality Control).

Requirements

  • Degree (MS or Ph.D.) in chemistry or chemical engineering.
  • 10+ years’ pharmaceutical small molecule manufacturing/process chemistry experience.
  • Strong technical background in small molecule development and manufacturing.
  • Familiarity with state-of-the-art technology development and implementation to improve manufacturing processes and analytical methodologies.
  • A robust understanding of quality requirements for GMP drug substance manufacturing
  • Proven ability to manage CMO’s to achieve goals on aggressive timelines.
  • Thorough understanding of broad CMC aspects concerning the development, manufacturing, and analysis of small molecule therapeutics.
  • Experienced in the use of systematic investigation techniques to identify causes of process deviations, e.g., root cause analysis
  • Excellent working knowledge of process safety, QbD, PAT, and DOE
  • Experience in writing CMC documents for regulatory submissions (IND/IMPD/NDA/MAA).
  • Strong understanding of pharmaceutical development, quality and regulatory issues.
  • Ability to flexibly manage tasks (directly and indirectly) and variable workloads with demanding timelines.
  • Ability to critically evaluate and troubleshoot complex problems, while offering timely and informed options for resolution.
  • Strong verbal & written communication skills, with the ability to effectively interact with and influence different functional groups across all levels of management.
  • Proficiency with Microsoft software (Word / Excel / PowerPoint).
  • Position requires up to 20% travel.

What we offer:

  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts.
  • A culture inspired by our values: put patients first; think independently, be radically transparent; act nimbly; and let science speak.
  • Learning and development training to help employees be the best version of themselves. 
  • Collaborative business environment.
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs).
  • Excellent benefits package. 
  • Flexible PTO.
  • With office locations in San Francisco, Boston, New York and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs.
  • Fast-paced, data-driven, work environment with world-class R&D minds and capabilities.
  • Work with the most productive groups of R&D operators in the industry.
  • Partnerships with leading institutions.
  • A platform for meaningful scientific contributions to shine.
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead and supported in their efforts to do so.
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Director Drug Substance Development and Manufacturing

Apply Now