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- Tasks: Manage projects to launch innovative therapies in the biotech field.
- Company: MoonLake Immunotherapeutics is a cutting-edge biopharmaceutical company focused on transformative healthcare solutions.
- Benefits: Enjoy remote work options, career growth opportunities, and a supportive learning environment.
- Why this job: Be part of groundbreaking projects that aim to revolutionise patient outcomes globally.
- Qualifications: Bachelor's degree in science; 5+ years in project management or biologics manufacturing.
- Other info: Work in a hybrid model, with 2 days a week in our new Cambridge office.
The predicted salary is between 36000 - 60000 £ per year.
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Join to apply for the CMC Project Manager role at MoonLake Immunotherapeutics (NASDAQ: MLTX)
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.
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
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CMC Project Manager employer: MoonLake Immunotherapeutics (NASDAQ: MLTX)
Contact Detail:
MoonLake Immunotherapeutics (NASDAQ: MLTX) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CMC Project Manager
✨Tip Number 1
Familiarise yourself with the specific regulatory processes mentioned in the job description, such as BLA, MAA, and PAI. Understanding these processes will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the biopharmaceutical industry, especially those who have experience in CMC project management. Engaging with them can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Showcase your project management skills by discussing relevant projects you've managed in the past. Be prepared to explain how you handled time, cost, quality, and risk management, as these are crucial for the role.
✨Tip Number 4
Research MoonLake Immunotherapeutics thoroughly, including their core values and recent developments. Tailoring your conversation during interviews to align with their mission and values can set you apart from other candidates.
We think you need these skills to ace CMC Project Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in project management and CMC, particularly in drug substance and drug product manufacturing. Use specific examples that demonstrate your skills in managing timelines, budgets, and stakeholder relationships.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also reflects your understanding of MoonLake Immunotherapeutics' mission and values. Mention how your background aligns with their goals, especially in launching innovative therapies.
Highlight Relevant Skills: In your application, emphasise your strong project management skills, particularly in risk management and communication. Provide examples of how you've successfully navigated complex projects and built relationships across departments.
Showcase Your Passion: Convey your enthusiasm for the role and the company in your application. Discuss why you are excited about the opportunity to contribute to MoonLake's mission of transforming global healthcare through innovative treatments.
How to prepare for a job interview at MoonLake Immunotherapeutics (NASDAQ: MLTX)
✨Showcase Your Project Management Skills
As a CMC Project Manager, you'll need to demonstrate strong project management skills. Be prepared to discuss specific examples of how you've managed time, cost, quality, and risk in previous projects. Highlight your experience with regulatory submissions and vendor management.
✨Understand the Biologics Landscape
Familiarise yourself with the drug substance and drug product processes, especially in biologics. Research MoonLake Immunotherapeutics and their focus on sonelokimab. Being knowledgeable about their products and the market will show your genuine interest in the role.
✨Prepare for Behavioural Questions
Expect questions that assess your ability to build relationships and influence stakeholders. Prepare examples that showcase your negotiation skills and how you've successfully navigated cross-functional interdependencies in past roles.
✨Demonstrate Adaptability and Learning
MoonLake values a learning environment and adaptability. Share instances where you've taken on new challenges or projects outside your comfort zone. This will illustrate your willingness to grow and contribute to the company's innovative culture.
