CMC Project Manager

MoonLake Immunotherapeutics; Cambridge; Hybrid; GBP 55,000 - 80,000; Full time

Job summary

Join MoonLake Immunotherapeutics as a CMC Project Manager and leverage your expertise in drug substance and product management. This role involves overseeing project delivery for regulatory submissions, fostering interdepartmental relationships, and contributing to innovative healthcare solutions in a supportive environment. Enjoy a flexible, dynamic workplace in Cambridge with clear paths for career progression.

Benefits

Flexible work-life balance

Learning Environment

Career Growth opportunities

Impactful work on global healthcare projects

Qualifications

• 5+ years of experience in a PM / PMO environment.
• 5-10 years DS or DP (biologics) manufacturing experience.

Responsibilities

• Ensure on-time and on-budget delivery of project goals and milestones.
• Support Senior Director in governance and operational plans.
• Manage external suppliers and vendors.

Skills

Project Management

Communication

Negotiation

Organizational Skills

Time Management

Education

Bachelor’s degree in science

Project Management Certification

Job description

Job Purpose

As CMC Project Manager, you will provide your Project Management and CMC knowledge and expertise to support the Drug Substance (DS), Drug Product (DP) and Device teams and management of their vendors/suppliers through BLA, MAA and PAI processes to launch Sonelokimab in the US and EU markets.

Major Accountabilities:

• Work with DS, DP and Device team to ensure on-time, in-full and on budget delivery of internal project goals and milestones and key documentation for regulatory submissions.
• Work with external suppliers and vendors (alliance / account management) to ensure delivery of MoonLake’s project goals and milestones and key documentation for regulatory submissions.
• Support the Senior Director Project Management in ensuring adherence to the Moonlake governance structure and processes.
• Keep MoonLake Operational Plans (MOPs) up to date in SmartSheets and other PM tools as required through interactions with key business stakeholders and translate these into meeting materials / status reports / priority lists etc. for the different governance meetings.
• Assist in the arrangement and management of governance meeting agendas, slide decks, minutes etc.
• Champion and foster a culture change promoting and identifying cross functional interdependencies.
• Provide the Senior Director Project Management with project status updates, feedback, and appropriate reporting on the MoonLake Operation Plan.
• Evaluating risk on company projects and assist with identifying owners and mitigations.
• Use the MOP to assess KPIs, capacity and resourcing, demand planning & actuals including 3rd parties.
• Run projects not within the CMC arena to further personal development and deliver MoonLake’s development and commercial strategy.

Your profile

Education:

• Bachelor’s degree in science; certification in Project Management advantageous but not essential

Experience:

• +5 years of experience in a PM / PMO environment
• +5-10 years DS or DP (biologics) manufacturing experience in a fast paced start-up or C(D)MO environment

Skills/knowledge/behavioural competencies:

• Strong project management skills in the areas of time, cost, quality and risk management
• Excellent written/verbal communication
• Prioritisation/organisation skills
• Ability to build Relationships with stakeholders across multiple departments and geographies, internally and externally
• Negotiation and influencing skills.
• Ability to scope, plan, execute, and track projects with autonomy, if assigned.
• Excellent skills with Microsoft Word Office, Excel, PowerPoint, Outlook Smartsheets etc.
• Identifying interdependencies and links for activities across functions not just within CMC

Work Location:

• 2 days a week in our brand new Cambridge Office(s)

Why us?

An exciting job opportunity awaits you!

MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.

What we offer:

Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.

Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.

Flexibility and Balance:Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.

Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.


Our Core Values

We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:

We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.

We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.

We unlock value: We aspire to create long-term value for investors and communities.