Senior Director, Biologics Drug Substance Manufacturing (AC20-225)

Catalyst Biosciences has an exciting opening and is seeking a Senior Director of Biologics Drug Substance Manufacturing. This impactful position will report to the SVP of Biologics Development and Manufacturing and has primary responsibility for managing the Contract Manufacturing Organization (CMO) activities including process development, process improvements, technology transfers, scale up and clinical manufacturing of drug substance compounds. Catalyst Biosciences is advancing several high potency parenteral recombinant compounds, targeted for subcutaneous delivery, through preclinical to late stage clinical trials with the intent of commercializing.

About Catalyst Biosciences, the Protease Medicines company

Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a pre-clinical C3-degrader program partnered with Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency and C4b-degraders designed to target disorders of the classical complement pathway as well as other complement programs in development.

Responsibilities

  • Manage relationships with Drug Substance CMOs, CROs and key suppliers including coordination, communication and technical oversight, to ensure timely delivery of cGMP products to support clinical trialsServe as primary technical and operational point of contact to the CMOs to support batch manufacture and testing, deviation investigation, batch review and release of GMP material
  • Collaborate with CBIO Project Management and CMOs in developing project plans and schedules and ensure that tasks are executed according to the operational plans, Development & Master Services Agreement, cGMP requirements and regulatory commitments
  • Lead manufacturing development activities, technology transfer and scale-up of process improvements with our CMO partners and our business collaborators.
  • Participate in preparation, review and approval of CMC sections of regulatory filings
  • Provide technical recommendations for assay development / validation, evaluating process data, trouble-shooting and root cause analysis as well as providing strategic recommendations leading to improved yields, cost of goods and process robustness
  • Support additional development activities and subsequent technology transfer and manufacturing of the drug substance, as needed
  • Arrange and oversee shipments of cell lines, drug substance and associated samples to third party warehouses, CRO and drug product CMOs
  • Liase and work with third party CROs for characterization testing of the drug substance
  • Travel globally as required to CMO, CRO and key vendor sites to represent Catalyst for Manufacturing oversight and partnership development purposes
  • Partner with key Catalyst functions including Quality, Project Management, Clinical Operations, Preclinical, Finance and Regulatory Affairs

**Title/Level to commensurate with education and experience.

Requirements

  • PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 10 years in the biotech/pharmaceutical manufacturing environment
  • Direct experience with managing internal recombinant mammalian and microbial GMP manufacturing activities required
  • Proven success in global CMO management with recombinant mammalian and microbial commercial and clinical products required
  • Technical expertise in development and full-scale manufacture of recombinant mammalian and microbial biologic products. Direct experience working with recombinant Factor drug substance is preferred.
  • Demonstrated ability to work effectively in a team-oriented CMC environment
  • Ability to effectively manage vendors globally
  • Excellent communication skills, both written and oral

Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to jobs@catbio.com, referencing requisition number (AC20-225) in the subject line.

Manager, Clinical Supply Chain (AC21-268)

Catalyst Biosciences is seeking a motivated Supply Chain leader to join our Biologics Development and Manufacturing team as our Manager, Clinical Supply Chain.The ideal candidate will play a key leadership role driving the planning, coordination, and execution of activities related to procurement, distribution, shipping logistics for clinical supplies to clinical sites globally in support of the Clinical trials.

About Catalyst Biosciences, the Protease Medicines company

Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a pre-clinical C3-degrader program partnered with Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency and C4b-degraders designed to target disorders of the classical complement pathway as well as other complement programs in development.

Responsibilities

  • Senior-level contributor responsible for leadership and management of network of Suppliers and vendors and establish an effective Supply Chain.
  • Manage relationships with CMOs, CROs, and key suppliers including coordination, communication, and technical oversight, to ensure timely delivery, shipment, and distribution of cGMP products, Standard of Care, and other ancillary supplies to support clinical trials.
  • Collaborates with other departments and stakeholders to identify and maintain resources needed to maintain an effective supply chain.
  • Establishes performance metrics for measurement, comparison, or evaluation of factors affecting the supply chain.
  • Develops and maintains detailed inventories of materials and supplies located at the CMOs, at sites, and in the Warehouse.
  • Maintains the required quantity of supplies and materials to optimize production. Actively monitors inventory of supplies and ensures a robust supply by proactively engaging with the third-party suppliers and vendors.
  • Analyzes current inventories and procedures; develops strategy and suggests improvements to increase efficiency of supply chain and minimize delays in procurement and shipment of supplies.
  • Develops policies to increase efficiency throughout the supply chain while ensuring quality and safety; implements subsequent changes to processes.
  • Identifies optimal shipment and transportation routes with attention to consolidation of warehousing and distribution.
  • Negotiates prices for raw material and delivery with suppliers, vendors, and/or shipping companies.
  • Participates as an advisory member of the product development team, providing information and guidance on availability and cost of supplies and materials.
  • Acts as part of the team coordinating engineering changes, product line extensions, or new product launches to ensure timely and orderly material and production flow transitions.
  • Monitors the performance of suppliers, assessing their ability to meet quality and delivery requirements; identifies and qualifies new suppliers in collaboration with other departments.
  • Performs other related duties as assigned.

**Title and level to commensurate with education and experience.

Requirements

  • Master’s degree in business or a scientific discipline with a minimum of 7 years direct experience in a development environment or bachelors with a minimum of 10 years experience in a relevant position is required.
  • Ability to effectively manage vendors globally.
  • Excellent communication skills (interpersonal, written, and verbal).
  • Must be well organized, proactive, detail-oriented, mature, and professional.
  • Excellent interpersonal and negotiation skills with a proven ability to create and maintain positive working relationships with vendors, suppliers, shippers, and customers.
  • Excellent organizational skills and attention to detail.
  • Thorough understanding of company products and logistics.
  • Strong analytical and problem-solving skills.
  • Proficient with Microsoft Office Suite or related software.
  • Experience in a fast-paced environment.
  • Demonstrated skills in Catalyst’s Core Competencies:
    • Leadership
    • Drive, Intensity, Enthusiasm
    • Goal Orientation/Commitment to Task/Follow-up
    • Teamwork
    • Attention to Quality & Detail
    • Decision Making & Problem Solving
    • Flexibility
    • Ownership & Accountability

Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to jobs@catbio.com, referencing requisition number (AC21-268) in the subject line.

Senior Scientist, Drug Substance Development & Manufacturing (AC20-219)

We are currently seeking to hire a motivated Senior Scientist, Drug Substance Development & Manufacturing with Purification and Drug Product experience to join our CMC team. The ideal candidate will play a key role in the planning, coordination, and execution of drug substance and drug product development at the CMOs.

About Catalyst Biosciences, the Protease Medicines company

Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a pre-clinical C3-degrader program partnered with Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency and C4b-degraders designed to target disorders of the classical complement pathway as well as other complement programs in development.

Responsibilities

  • Responsible for supporting drug substance/purification and drug product manufacturing activities
  • Managing relationships with CMO’s and key suppliers including coordination and technical oversight, to ensure timely delivery of cGMP products to support clinical trials
  • Review batch records, development protocols and reports
  • Supporting documentation for batch manufacture and testing, while providing trouble-shooting support as well as root cause analysis for deviations
  • Prepare formulation data summaries, technical reports, scientific presentation and regulatory documents. As well as preparation and review of CMC sections of regulatory filing
  • Analyze/interpret process data and write technical protocols and reports
  • Review batch release and stability data and trend process performance

Requirements

  • Ph.D. or Masters in Life Sciences of Chemical Engineering
  • Ph.D. with 4-5 years or Masters with 8+ years of direct experience in Biologics, Process Development, CMC, MSAT and manufacturing.
  • Drug Substance/Purification and Drug Product Experience (Biologics)
  • Experience with upstream and downstream Process Development including UF/DF, formulation and bulk fill.
  • Late stage Process Development Experience (Phase III to BLA) is preferred.
  • 4-5 years Experience working with or part of a Process Transfer or MSAT Team
  • Experience with Tech Transfer and Process Scale Up for recombinant proteins is highly desirable
  • Working and maintaining relationships with CMO’s, DS, DP
  • Flexible, adaptive attitude, ability to problem solve, multitasker, resilient with a positive outlook.

Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to jobs@catbio.com, referencing requisition number (AC20-219) in the subject line.

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