Director, CMC and Life Cycle Management (LCM) Lead

Coherus Oncology•Redwood City, CA

6d•Onsite

About The Position

The Director of CMC and Life Cycle Management (LCM) Lead is responsible for creating and driving programs from development to commercial launch in collaboration with CMC leadership and cross functional teams and for leading Life Cycle Management (LCM) activities post launch.

Requirements

B.S. or B.E. in chemical engineering, bioengineering or related field.
8+ years of Pharmaceutical/ Biotech industry experience in technical operations
Strong technical understanding of CMC development from early to late stage, validation, and commercialization requirements
Working knowledge of GMP regulations, PPQ expectations, and regulatory filing timelines (IND, BLA/NDA, supplements)
Knowledge of applicable Quality and Regulatory guidelines
5+ years of Project Management experience and knowledge of project management methodologies, concepts and techniques is required; Project Management certificate is a plus
Prior experience working in a fast-paced, entrepreneurial, development-stage company
Prior experience managing third-party relationships
Ability to manage complex, cross-functional projects with internal and external stakeholders
Excellent written, communication and organizational skills
Expertise using Project Management software to build timelines and manage resources, risks, and costs
Rapidly integrate new information into existing plans
Work well under tight deadlines, with the ability to prioritize workload against deadlines and corporate objectives
Work well in cross-functional teams and be able to communicate effectively with external partners, peers, and senior management
Strong negotiating and interpersonal skills, and the ability to clearly present recommendations
Possess excellent decision-making, leadership, interpersonal, verbal and written communication skills

Nice To Haves

A postgraduate degree (e.g. MS, PhD) is a plus
Experience in managing late-stage commercial products is a plus
Project Management certificate is a plus

Responsibilities

Lead and facilitate CMC and LCM cross-functional teams, including scheduling, developing agendas, writing and distributing meeting minutes, and tracking decisions and action items
Partner with cross-functional leadership to establish comprehensive, functionally integrated, end-to-end CMC timelines that are aligned with overall program timelines and strategy
In collaboration with internal project teams and external vendors Implement project plans
Identify and manage critical path activities and their interdependencies
Identify and proactively mitigate roadblocks
Identify and communicate risks and key mitigations
Capture and communicate progress to senior leadership; escalate potential delays with proposed solutions
Develop and manage program budgets, including purchase orders and SOWs
Responsible for all project team documentation, including agendas, minutes, actions, decisions, timelines, scorecards, goals, and dashboards
Facilitate internal project team meetings and weekly working team calls with vendors
Present project updates, issues, path forward options, and recommendations to program team and functional Senior Management in timely fashion
Collaborate with personnel across Coherus to ensure alignment around key business objectives
Ensure that projects adhere to agreed-upon scope, timelines, resources, and budget; resolve or communicate departures