Calcilytix Therapeutics, Inc.
San Francisco, California
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.
- Oversee contract development organizations to lead development and optimization of drug product formulations 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.
- 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 product development activities.
- Generate and/or review Process Validation documentation, including Product Validation Master Plans, Statistical Product Sampling Plans, Cleaning Validation Plans, and Process Performance Qualification Protocols.
- Prepare technical reports in support of planned regulatory submissions.
- Write, review and approve CMC portions of study reports and manufacturing process documentation for compliance with cGMP and other appropriate regulations and guidelines.
- Assist in supply chain logistics for drug product manufacturing activities.
- Interface effectively with other disciplines (e.g., Clinical, Nonclinical, Drug Substance, Quality Assurance, Analytical Development and Quality Control).
Experience and Skills:
- Advanced degree in pharmaceutics, pharmaceutical science, chemical engineering, or other related scientific discipline.
- 10+ years of hands-on experience with increasing responsibility in solid oral dosage manufacturing process development. Experience with Drug Product validation and commercial manufacturing drug product manufacturing a plus.
- A robust understanding of quality requirements for GMP drug product manufacturing. Knowledge of ICH requirements.
- Experience managing engineering challenges of large scale solid oral dosage processes involved in manufacturing, such as blending, granulation, compression and packaging.
- Highly experienced in solid oral dosage form formulation development
- Experience in writing CMC documents for regulatory submissions (IND/NDA/MAA).
- Strong understanding of pharmaceutical development, quality and regulatory issues.
- Hands-on GMP experience with all phases of drug development, as well as in-depth knowledge and full understanding of GMP requirements.
- 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.
Competitive Compensation and Benefits
Calcilytix is located in downtown San Francisco, CA. easily accessible from BART.