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.
About us
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients.
We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.
Further information is available at www.moonlaketx.com