Director, CMC and Life Cycle Management (LCM) Lead
Scorpion Therapeutics, Redwood City, CA, United States
Title:
Director, CMC and Life Cycle Management (LCM) Lead
Reports to:
Vice President, Technical Operations
Location:
Redwood City, CA
Classification:
Exempt
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; elevate 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.
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Director, CMC and Life Cycle Management (LCM) Lead
Reports to:
Vice President, Technical Operations
Location:
Redwood City, CA
Classification:
Exempt
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; elevate 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.
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