Position Overview

As a key member of the Pipeline team, the Manager, CMC Development is responsible for contributing to strategic and technical management of CMC project(s) including guiding cross-functional teams, establishing and executing phase-appropriate manufacturing processes, and ensuring appropriate supplies of pre-clinical, clinical, and commercial material(s). Additionally, the Manager will contribute to phase-appropriate SOPs and documentation that support regulatory submissions and interactions. Ideal candidates will be highly collaborative, have a deep understanding of end-to-end CMC responsibilities, command strong communication skills, and be detail- and results-oriented.

Essential Functions

  • Provide strategic and technical guidance for the development and execution of phase- appropriate CMC strategies across the portfolio of products
  • Coordinate and facilitate CMC team meetings and CMO meetings (regularly scheduled and ad hoc) by providing meeting agendas, minutes, and tracking action items
  • Contribute to the management and monitoring of departmental budget development for CMC projects including owning and tracking purchase-to-pay activities and COGS to ensure project budget goals are achieved
  • Identify opportunities to create CMC synergy and mitigate costs across product lines
  • Represent CMC on program teams and work with Research, Nonclinical, Clinical, Regulatory, and program team leadership to ensure appropriate CMC strategy
  • Ensure the production of clinical products at external CROs and CDMOs
  • In conjunction with the Quality team, ensure products meet specifications, are compliant with cGMPs, and meet regulatory requirements
  • Provide clear, succinct, and timely communication regarding CMC developments
  • Establish and maintain positive and productive relationships with internal project teams and external partners
  • Contribute to manufacturing process investigations including upstream, downstream and drug products (i.e., fill/finish) and draft reports summarizing deviations, non-conformances, and CAPAs as required
  • Manage CMC material resource allocation and planning to support project deliverables including coordinating shipments, import/export activities, and tax coordination
  • Partners with the Quality team to address manufacturing CAPAs as appropriate
  • Write and/or contribute to technical CMC documentation including technical reports, batch records, protocols, and change controls
  • Develop and provide consistent project tracking and project reporting to CMC Senior Management and project teams
  • Author and/or review relevant drug substance and drug product CMC sections for global regulatory submissions (e.g., IND/CTA, BLA/MAA)
  • Actively identifies, recommends, and implements opportunities for continuous improvement
  • Work Safety – Ensure that all tasks and functions of position are always performed in a safe manner and that all procedures and requirements are properly followed to accomplish assigned tasks
  • Other duties as assigned

Required Qualifications and Skills

  • Master’s Degree in chemical or bioengineering, biochemistry, or related field
  • 4+ years of directly related professional experience in biotech or life sciences; startup experience preferred
  • Knowledge of biologics drug development lifecycle
  • Experience working with cross-functional groups on biologics process development and/or manufacturing
  • Experience scaling and optimizing lab procedures under GMP conditions
  • Understanding of FDA regulations including expertise in GMP systems
  • Experience in applying Pharmaceutical Quality by Design (QbD) principles
  • Experience overseeing, managing, and motivating external CMC partners and teams
  • Demonstrated ability to implement CI principles using phase-appropriate methods
  • Clarity in verbal and nonverbal communication including creating and communicating budgets, dashboards, and project plans
  • High degree of integrity to handle confidential and sensitive information
  • Strong ability to prioritize and manage multiple projects
  • High degree of detail orientation with strong organizational skills
  • Composure, positivity, flexibility, organizational skills, and time management ability necessary to succeed in a performance-driven environment
  • Ability to work well independently and without close supervision, keeping focused on short- and long-term objectives
  • Live near or willingness to travel to Pittsburgh, PA

Diversity & Inclusion: Our Foundation for Innovation

At Peptilogics, diversity, inclusion and equality are embedded in our DNA. Together, regardless of gender, race, ethnicity, national origin, age, sexual orientation or identity, education or disability, the Peptilogics team envisions a workplace where all employees feel valued and respected. We provide equal employment opportunities to all employees and applicants as we continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our team members. 

Peptilogics is committed to serving as a model of diversity and inclusion for the entire biotech and biopharmaceutical industry and to maintaining an inclusive environment with equitable treatment for all. It fuels our innovation, reinforces our vision, and more closely connects us to the communities we serve.

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