Director, CMC and Life Cycle Management (LCM) Lead

Overview:

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.

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

Qualifications:

• B.S. or B.E. in chemical engineering, bioengineering or related field. A postgraduate degree (e.g. MS, PhD) is a plus


• 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)


• Experience in managing late-stage commercial products is a plus


• 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 

The Base Salary Range for this position is $190,000 to $240,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.

Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.