At a Glance
- Tasks: Manage projects to launch innovative therapies in the US and EU markets.
- Company: Join MoonLake, a dynamic biotech company revolutionising healthcare.
- Benefits: Flexible remote work, career growth, and a supportive learning environment.
- Other info: Collaborative culture with opportunities for professional development.
- Why this job: Make a real impact on global healthcare with groundbreaking projects.
- Qualifications: 5+ years in project management and biologics manufacturing experience.
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.
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 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 headquartered in Zug, with hubs in Cambridge.
Remote CMC Project Manager in Newport employer: MoonLake Immunotherapeutics
MoonLake Immunotherapeutics is an exceptional employer, offering a dynamic and innovative work environment where passionate individuals can thrive. With a strong focus on employee growth, we provide opportunities for learning alongside experienced professionals while contributing to groundbreaking projects that aim to transform global healthcare. Our hybrid work model promotes a healthy work-life balance, ensuring that our team members can excel both personally and professionally in our brand new Cambridge office.
Contact Details:
MoonLake Immunotherapeutics Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Remote CMC Project Manager in Newport
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at MoonLake or similar companies. A friendly chat can sometimes lead to job opportunities that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by researching MoonLake's projects and values. Show us you’re not just another candidate; demonstrate how your experience aligns with our mission to revolutionise healthcare.
✨Tip Number 3
Practice your pitch! Be ready to explain how your project management skills can help us meet our goals. Highlight your experience with DS and DP processes, and don’t forget to mention your knack for building relationships across teams.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows us you’re genuinely interested in being part of the MoonLake team.
We think you need these skills to ace Remote CMC Project Manager in Newport
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experience mentioned in the job description. Highlight your project management expertise, especially in CMC, and any relevant experience with regulatory submissions.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you're passionate about this role and how your background aligns with our mission at MoonLake. Be sure to mention specific projects or achievements that showcase your abilities.
Showcase Your Communication Skills:Since excellent written communication is key for this role, ensure your application is clear, concise, and free of errors. Use professional language but let your personality shine through!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity at MoonLake!
How to prepare for a job interview at MoonLake Immunotherapeutics
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of Chemistry, Manufacturing, and Controls (CMC) processes. Be ready to discuss how your experience aligns with the Drug Substance and Drug Product teams, and think about specific examples where you've successfully managed projects in a similar environment.
✨Showcase Your Project Management Skills
Prepare to highlight your project management expertise, especially in time, cost, quality, and risk management. Have concrete examples ready that demonstrate how you've delivered projects on time and within budget, particularly in fast-paced settings.
✨Build Relationships Virtually
Since this role involves working with various stakeholders across different geographies, practice how you'll communicate and build relationships remotely. Think of ways to demonstrate your negotiation and influencing skills during the interview.
✨Be Ready for Governance Discussions
Familiarise yourself with governance structures and processes, as well as how to prepare meeting materials and status reports. Be prepared to discuss how you would keep operational plans up to date and manage agendas effectively.
