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OncXerna Therapeutics
Waltham, Massachusetts, United States
30+ days ago
OncXerna Therapeutics
Waltham, Massachusetts, United States
30+ days ago

Description

JOB SUMMARY: 

OncXerna seeks experienced and highly motivated individual to join its team in Waltham, Massachusetts. This is an ideal position for an individual with a strong background in biologics drug development who thrives in a team-oriented, fast-paced, and entrepreneurial biotech environment and who is hands on. The individual in this role will develop and maintain relationships with counterparts and functional leaders in clinical development, clinical operations, translational medicine and regulatory affairs, and will be an integral member of a dynamic and rapidly growing CMC team.  Core responsibilities will include CDMO management of all analytical development activities and oversight of Quality Control testing of our monoclonal antibody programs.

KEY RESPONSIBILITIES:

The Sr. Director of Analytical Development and Quality Control is responsible for the development and implementation of in-process, release and stability testing strategies for the manufacture of drug substance and drug product.  The position reports to the Vice President of CMC and will include the following duties:

  • Management of Contract Manufacturing Organizations (CMOs) to ensure technical solutions are GMP compliant and phase appropriate
  • Establishment of product control strategy for drug substance and drug product across multiple programs
  • Oversight of the development and validation of analytical methods, and the establishment of appropriate product specifications
  • Management of external Quality Control testing sites to ensure adherence to established drug product control strategy and drug supply timelines
  • Authoring of high-quality regulatory CMC documents to the health authorities in compliance with GMP and local authority requirements
  • Timely submission of all reporting requirements including annual and periodic reports
  • Leading CMC at internal meetings as well as at meetings with business partners and regulatory agencies for all analytical related issues
  • Partner with CMC team to provide responses with regulatory agencies/health authorities as needed
  • Providing creative and innovative solutions while being an advocate for compliance
  • Proactive management of issues and information sharing with key internal/external stakeholders
  • Participation in drug supply chain planning


Requirements

QUALIFICATIONS AND SKILLS

  • Advanced degree (e.g., MSc or PhD) or equivalent education/degree in Chemistry, Biochemistry, or related pharmaceutical science is required
  • Ten (10) – fifteen (15) years of experience in biologics CMC within the biotech/pharmaceutical industry with late-stage development (Phase 3) and commercial experience highly preferred
  • A demonstrated understanding of the interdependencies of research, technical development, GMP Manufacturing, Quality, Supply Chain, Preclinical, Clinical, Regulatory and Product Strategy functions
  • Strong technical background and expertise in protein characterization methods including ELISA, HPLC/UPLC, SEC, and cell-based assays; experience in Mass Spectrometry (MS) analysis a plus
  • Solid understanding of analytical assay development, qualification, and validation requirements to meet regulatory standards
  • Familiarity with regulatory agency guidelines and experience writing analytical CMC sections for regulatory filings; experience in representing CMC at regulatory agency meetings a plus (FDA, EMA, MHRA)
  • Experience in overseeing CMOs (including project management and technical oversight) to include GMP vendor adherence to best practices, timelines and deliverables
  • Experience leading technical and/or cross functional teams
  • Strong presentation skills
  • Strong communicator and good written/verbal skills
  • Must be a highly motivated, thoughtful, independent, results-driven individual capable of functioning in a fast-paced collaborative environment

LEADERSHIP COMPETENCIES

  • Places a priority on getting results with an emphasis on high quality outcomes
  • Participates in making timely, data-driven decisions
  • Develops and maintains effective working relationships with people across cultures
  • Actively seeks and receives coaching/mentoring; may provide guidance to junior members of team
  • Encourages collaboration across study teams, vendors, and geographies
  • Addresses conflicts in positive, solutions-oriented style
  • Displays a willingness to challenge the status quo and take risks
  • Responds resourcefully to changing business demands and opportunities

Job Information

  • Job ID: 58357868
  • Location:
    Waltham, Massachusetts, United States
  • Company Name: OncXerna Therapeutics
  • Position Title: Senior Director of Analytical Development and Quality Control
  • Job Function: Biochemistry,
    Drug Development,
    Quality Control
  • Job Type: Full-Time
  • Min Education: Master's Degree
  • Min Experience: Over 10 Years
  • Required Travel: 10-25%
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