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- Tasks: Manage analytical test methods for clinical trials and vendor activities.
- Company: Join MoonLake, a dynamic biotech company innovating in healthcare.
- Benefits: Enjoy remote work options, career growth, and a supportive learning environment.
- Why this job: Make an impact on global healthcare with groundbreaking projects in a collaborative culture.
- Qualifications: Bachelor's degree and 5+ years in CMC analytics within pharma/biotech.
- Other info: Work in our new offices in Cambridge, Porto, or Zug, 2 days a week.
The predicted salary is between 43200 - 72000 £ per year.
As an Associate Manager, Analytics Technical Operations, you are responsible for supporting the oversight and management of the history, validation and implementation of analytical test methods that support characterization, stability and batch release testing for Phase II/III clinical trials, BLA preparation and post-marketing., * Support the oversight, management and review of third-party vendor activities, with accountability for technical approaches, compliance with current regulatory and industry standards, study level timeliness and quality.
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Support and technically contribute to the further development of methods for MoonLake’s proprietary trivalent Nanobody® sonelokimab.
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As appropriate to outsourced cGMP biologics manufacture, ensure CMC Analytical Development records, documentation and vendor reports support regulatory inspections and submissions. Ensures the delivery of high-quality CMC sections for IND/CTA/BLA filings.
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Act as contact for CMC analytics vendors to ensure effective communication between MoonLake and all external vendors.
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Communicate progress and identify risks and issues arising to the Director, Analytics Technical Operations and other MoonLake development team members as appropriate.
Education: Bachelor of Science degree in relevant scientific discipline.
Experience:
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5+ years of experience in the pharmaceutical/biotech industry of CMC analytics for the clinical development of biological therapeutics.
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Experience of managing outsourced activities at cGMP vendors.
Skills/knowledge/behavioural competencies:
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Experience in the development and validation of analytical methods to support in-process and release testing of biologics. Robust knowledge of cGMP and related regulatory standards for CMC analytics.
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Sound understanding of Critical Quality Attributes principles.
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Excellent oral and written communication skills.
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Highly organised, able to prioritise work, work well under pressure and meet deadlines.
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Independent, self-starter with a proactive, problem solving approach.
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Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external advisors including CROs and consultants.
Work Location: 2 days a week in our brand new Cambridge, Porto or Zug office(s)
Why us?
An exciting job opportunity awaits!
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.
Associate Manager, Analytics Technical Operations employer: MoonLake Immunotherapeutics
Contact Detail:
MoonLake Immunotherapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Manager, Analytics Technical Operations
✨Tip Number 1
Familiarize yourself with the specific analytical methods and regulatory standards mentioned in the job description. Understanding cGMP and Critical Quality Attributes principles will give you a solid foundation to discuss your relevant experience during the interview.
✨Tip Number 2
Highlight your experience managing outsourced activities at cGMP vendors. Be prepared to share specific examples of how you've ensured compliance and quality in past projects, as this will demonstrate your capability to handle similar responsibilities at MoonLake.
✨Tip Number 3
Showcase your communication skills by preparing to discuss how you've effectively collaborated with external vendors and internal teams in previous roles. This is crucial for the position, as you'll need to act as a contact for CMC analytics vendors.
✨Tip Number 4
Emphasize your proactive problem-solving approach and ability to work under pressure. Prepare examples that illustrate how you've successfully prioritized tasks and met deadlines in fast-paced environments, aligning with the expectations outlined in the job description.
We think you need these skills to ace Associate Manager, Analytics Technical Operations
Some tips for your application 🫡
Understand the Role: Make sure you fully understand the responsibilities and requirements of the Associate Manager, Analytics Technical Operations position. Tailor your application to highlight relevant experience in CMC analytics and managing outsourced activities.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 5+ years of experience in the pharmaceutical/biotech industry, particularly focusing on analytical method development and validation for biologics. Use specific examples to demonstrate your expertise.
Showcase Communication Skills: Since excellent oral and written communication skills are crucial for this role, ensure that your application is well-written and free of errors. Consider including examples of how you've effectively communicated with vendors or team members in past roles.
Align with Company Values: Research MoonLake's core values and reflect them in your application. Show how your work ethic and approach align with their commitment to stellar science, going beyond expectations, and unlocking value for stakeholders.
How to prepare for a job interview at MoonLake Immunotherapeutics
✨Showcase Your Technical Expertise
Be prepared to discuss your experience with analytical test methods and how they relate to CMC analytics. Highlight specific examples from your past roles that demonstrate your ability to manage and validate these methods effectively.
✨Demonstrate Strong Communication Skills
Since the role involves liaising with external vendors and internal teams, practice articulating complex technical information clearly and concisely. Prepare to discuss how you have successfully communicated progress and addressed issues in previous projects.
✨Emphasize Your Organizational Skills
The job requires managing multiple tasks under pressure. Share examples of how you've prioritized work and met deadlines in fast-paced environments, especially in relation to clinical trials or regulatory submissions.
✨Align with Company Values
Familiarize yourself with MoonLake's core values: Stellar Science, Going Beyond, and Unlocking Value. Be ready to discuss how your personal values and work ethic align with these principles, and provide examples of how you've embodied them in your career.
