Associate Director, CMC Development

Location
San Diego, California, United States
Posted
Jul 10, 2021
Ref
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Discipline
Science/R&D, CMC
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
COMPANY
Prometheus Biosciences is a San Diego-based public biotechnology company pioneering a precision medicine approach to the discovery, development, and commercialization of novel therapeutics and companion diagnostic products for the treatment of inflammatory bowel disease (IBD). The company's precision medicine platform combines proprietary bioinformatics discovery methods with one of the world's largest gastrointestinal multiomics database to identify novel therapeutic targets and companion diagnostic approaches that will enable tailored treatments based on molecular patient stratification.

JOB SUMMARY

Prometheus Biosciences is seeking a highly motivated scientific leader to join as our Associate Director of CMC Development & Manufacturing. This impactful position will report to the Vice President of CMC Biologics and is primarily responsible for managing Contract Manufacturing Organization (CMO) activities in support of preclinical and clinical stage development programs. This is a high visibility role with opportunities for accelerated career growth.

RESPONSIBILITIES
  • Individual contributor responsible for technical leadership of drug substance, drug product development, manufacturing and supply chain activities in support of clinical and pre-clinical stage development programs
  • Apply scientific expertise to design and implement innovative solutions for development of therapeutic proteins to address key challenges and support project deliverables on accelerated
  • Independently designs, oversees, interprets and presents results from studies to proactively make recommendations for decision making and influence the direction of CMC development strategies and activities
  • Partner with internal and external stakeholders to develop and implement CMC plans in support of broader project team and organizational goals
  • Manage relationships with CDMOs, CROs and key suppliers including coordination, communication and technical oversight, to meet accelerated timelines and ensure timely delivery of cGMP supplies to support clinical trials
  • Serve as primary point of contact to the CMOs to provide technical oversight for cell line development, process development, formulation development, analytical method development and qualification, batch manufacture and testing, clinical packaging & labeling, supply chain management, stability studies, deviation investigation, batch review and release of cGMP material
  • Generate high quality data based on sound scientific principles and prepare data summaries, technical reports, scientific presentations and regulatory documents
  • Collaborate with internal and external stakeholders to support project plans and schedules, ensuring that tasks are executed in accordance with operational plans, cGMP requirements and regulatory commitments

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

REQUIREMENTS
  • Degree in a scientific discipline (e.g., Chemical Engineering, Biochemistry, or related field)
  • PhD with a minimum of 5 years' experience in a development environment, MSc with a minimum of 8 years' experience in early-stage clinical development, or bachelor's degree with a minimum of 10 year's experience
  • Highly experienced in one or more of the following areas: cell line development, process development, formulation development and/or analytical method development and qualification
  • Technical expertise in early-stage clinical development and cGMP manufacture of recombinant mammalian produced biologic products
  • Strong understanding and expertise in development and scale up of mammalian produced recombinant proteins
  • Sound knowledge and understanding in process development, formulation development, and analytical characterization therapeutic antibodies is desirable
  • Strong understanding of cGMPs, FDA, EU, ICH guidelines; as well as CMC content of regulatory submissions
  • Must have demonstrated experience in managing and influencing diverse project activities with third party manufacturing facilities at different geographical locations Strong project management experience with cross­ functional team leadership and participation skills
  • Demonstrated ability to work effectively in a team-oriented CMC environment and successfully influence others in cross-functional teams
  • Demonstrated ability to effectively manage CDMOs globally
  • Excellent communication skills (interpersonal, written and verbal)
  • Must be well organized, proactive, detail-oriented, mature and professional
  • Ability to multi-task and work efficiently in an environment with changing priorities
  • Experience in a fast-paced environment

The employee must conduct their work activities in full compliance with defined expectations, including Prometheus Bioscience's internal requirements, GMP and ISO, and all other applicable health authority. Prometheus Bioscience's internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

This document describes the major responsibilities of the job. It does not include all aspects of the position, such as the potential additional duties assigned by management, and the requirement for flexibility in assisting others for the company's overall benefit.

All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.