Position overview

The CMC Radiopharmaceutical Manager plays a critical role in overseeing the radiolabelling process, analytical and formulation development, and enabling preclinical and clinical development of therapeutic radiopharmaceuticals. This position entails providing technical support, managing technology transfer, and overseeing manufacturing and supply activities with Contract Development and Manufacturing Organizations (CDMOs). The post holder will collaborate with various teams, including CMC, regulatory, quality, and clinical operations, to ensure the successful development and supply of investigational therapeutic radiopharmaceuticals for clinical development.

Roles & Responsibilities：

• Oversee radiolabelling process, analytical, and formulation development.

• Provide technical support, technology transfer, and management of manufacturing and supply activities with CDMOs.

• Enable preclinical and clinical development of therapeutic radiopharmaceuticals.

• Support CMC, regulatory, quality, and clinical operations team.

• Manage outsourced therapeutic radiopharmaceutical CMC project activities at various stages of drug development.

• Manage projects according to milestones within agreed time, resources, and cost.

• Manage third-party CDMOs activities, partner network, and innovation, ensuring accuracy and reliability of generated data.

• Manage manufacture and supply of investigational therapeutic radiopharmaceuticals for clinical development, ensuring appropriate level of quality for patient safety.

• Review reports, batch data, and conduct trending/investigation of Out of Trend (OOT)/Out of Specification (OOS) results.

• Collaborate with and support the Quality Assurance function to ensure compliance with Good Manufacturing Practice (GMP).

• Collaborate with and support the regulatory function by authoring and/or reviewing electronic Common Technical Document (eCTD) modules.

• Monitor and highlight Intellectual Property opportunities.

• Comply with the Quality System.

• Provide input to company financial forecasts and budget setting activities; monitor expenditure and highlight any unplanned over or under spends.

Soft skills:

• Strong communication and interpersonal skills.

• Excellent organizational and time management abilities.

• Ability to work independently and prioritize workload effectively.

• Collaborative mindset with the ability to work effectively with cross-functional teams.

• Detail-oriented with a focus on accuracy and reliability of data.

• Demonstrated ability to address challenges and solve problems quickly.

• Adaptability and flexibility to navigate complex project requirements and changing priorities.

Experience:

• Extensive experience in pharmaceutical development, with a focus on radiopharmaceuticals.

• In-depth knowledge of ICH, FDA, and EMA guidance/regulations relevant to pharmaceutical drug development and manufacture.

• Proven experience in managing third-party vendors, including CDMOs.

• Strong project management skills.

• Experience in manufacturing pharmaceuticals, with expertise in process, analytical, or microbiology.

• Additional experience in the development of radiopharmaceuticals is highly desirable.

• Familiarity with authoring and reviewing eCTD Module 3 documents is a plus.

• Experience in outsourced manufacture, analysis, and/or supply chain management.

• Experience in sterile pharmaceutical manufacture/aseptic operations is a plus.

• Knowledge of radiopharmaceuticals analytical methods, process development, scale-up, or automation is advantageous.

Education:

Bachelor's degree in a relevant scientific field; advanced degree preferred.

Preferred industry background:

Life science or pharmacceutical industry

Other key points:

Ability to work from Denmark at least twice/month.

Position overview

As the Vice President of Finance, your role in crafting and executing financial strategy and planning is paramount to the success and growth of our organization, particularly as we navigate through the complexities of the biotechnology industry and prepare for potential public offerings. Your responsibilities will encompass a wide range of strategic financial activities aimed at optimizing financial performance, ensuring regulatory compliance, enhancing shareholder value, and guaranteeing the long-term sustainability of the company.

Roles & Responsibilities

Financial Strategy:

- Deeply understand business needs and develop and implement comprehensive financial strategies aligned with company’s overall objectives and growth plans.

IPO:

- Play a central role in preparing the company for its IPO, collaborating closely with external advisors and internal stakeholders to execute a comprehensive IPO strategy & planning from finance point of view.

- Lead team to build internal system, processes and controls according to public company standards and ensure compliance with all regulatory requirements governing IPOs.

- Oversee financial due diligence process, ensuring the accuracy and completeness of financial information provided to underwriters, regulators, analysts and potential investors.

- Provide timely and transparent communications on financial performance and corporate strategy, develop and maintain finance investor presentations to investors   

- Develop and implement post-IPO financial reporting and compliance processes to meet the requirements of public company governance.

- Support strategic initiatives and business development activities to drive long-term value creation for shareholders.

Financial Planning and Analysis:

- Oversee comprehensive financial planning processes, including budgeting, forecasting and Long-range planning to ensure alignment with strategic priorities and financial targets.  

- Review the analysis of financial statements, reports and metrics and provide timely and accurate insights to support strategic decision-making.

- Monitor key financial performance indicators, identifying trends and potential areas for improvement.

Finance Reporting:

- Ensure accurate and timely reporting in accordance with applicable requirements, especially to ensure alignment with future IPO requirements like SEC filling.

Internal control / Risk Management & Compliance:

- Institutionalize finance SOP, system, policy on a global level in the purposes of robust internal control and risk management, as well as future IPO requirements

Treasure, Cash Management and Tax:

- Monitor cash flow forecasting, liquidity planning and treasury operations to optimize cash resources and mitigate liquidity risks.

- Oversee banking relationships and debt facilities, and other alternative financings to support operational needs and capital requirements.

- Research global tax rules and make proper arrangements to reduce tax burdens and risks.

Team Leadership and Development:

- Build and lead a high-performing finance team, fostering a culture of collaboration, innovation and excellence.

Provide mentorship, coaching and professional development opportunities to team members, empowering team to achieve their full potential.

Qualification requirements and skills

· Proven track record of success in senior finance roles, with significant experience leading IPO processes (NASDAQ preferred) in the biotechnology or life sciences industry.

· Strong understanding of SEC regulations, Nasdaq listing standards and corporate governance best practices.

· Demonstrated ability to manage complex financial transactions, negotiate with external partners and navigate regulatory requirements.

· Excellent communication and presentation skills, with the ability to articulate complex financial concepts to diverse audiences.

· Strategic thinker with a proactive and results-oriented approach to problem-solving.

· Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively.

· Strong leadership skills, with the ability to inspire and motivate cross-functional teams toward common objectives.

Soft skills

· Demonstrate a deep understanding of cultural differences, work comfortably in a diverse, dynamic, fast-moving working environment

· Leverage intercultural competence to build strong working relationships across borders.

· Navigate complex decision-making processes with a high level of tact and diplomacy.

· Adapt communication styles to resonate effectively with local C-level leaders.

· Demonstrate a holistic, end-to-end perspective in analyzing processes and identifying improvement opportunities, proven experience in creating sustainable processes that drive operational excellence.

· Foster a collaborative environment to ensure seamless integration of new processes and effective knowledge transfer. 

Experience

· At least 15 years post qualification experience with minimum 4 years gained from top tier CPA firm.

· IPO and public company experience is a must.

Education

· Bachelor’s Degree in business or accounting or other related discipline is required.

· A Masters degree in Finance or Business Administration is preferred.

· Professional certifications: Certified Public Accountant (CPA), Chartered Financial Analyst (CFA), or Certified Management Accountant (CMA).

Preferred industry background 

· Previous working experience with international Biotech is preferred.

· Pharma experience/medical device is must. 

Position overview

We are seeking a highly skilled, reliable, organized and motivated Operations Head to oversee our newly established laboratory operations in Chengdu. The ideal candidate will have strong organizational and leadership abilities, enjoy multitasking, project management experience, along with a deep understanding of laboratory procedures and best practices in a biotech setting. He/she will play a critical role in shaping Lab’s culture, implementing processes, and interact with local government officers as a critical bridge with Shanghai team.

Roles & Responsibilities

Laboratory Management:

· Establish and oversee all aspects of laboratory operations in Chengdu, including new facility setup, equipment procurement & maintenance, EHS & Regulatory compliance, government relationship etc.

· Provide comprehensive support to our laboratories and staff, including maintaining lab functionality, managing stock and consumable inventories, handling urgent and regular bulk orders, daily monitoring and collection of biohazard waste, daily stocking of labs, receiving packages.

· Develop and implement standard operating procedures (SOPs) to ensure compliance with regulatory requirements and best practices in biotech.

· Coordinate and prioritize lab activities to ensure efficient workflow and timely completion of projects.

· Implement quality management systems (QMS) to monitor and improve laboratory processes, documentation, and data integrity.

· Evaluate new technologies and equipment, making recommendations for procurement and implementation.

· Provide Guidance and support to scientific team as needed.

· Stay abreast of advances in radiopharmaceutical science and technology, evaluating new methodologies and tools to enhance lab capabilities.

Government Interactions:

· Serve as the primary liaison with government agencies, regulatory bodies, and local authorities.

· Ensure compliance with all relevant regulations, permits, and reporting requirements.

· Prepare and submit documentation for regulatory approvals, inspections, and audits.

· Keep abreast of changes in regulations and advise management on potential impacts.

Site Management & Office Administration:

· Secure and optimize local benefits such as rental deductions and research grants.

· Research and apply for company/lab qualifications to enhance reputation and access new opportunities to best benefit for company.

· Manage Office facilities, supplies and vendor relationships.

Cross-functional Collaboration:

· Collaborate with other departments and remote teams to support company-wide initiatives.

· Communicate effectively with colleagues at all levels to facilitate information sharing and problem-solving.

Qualification requirements, experience and skills

· Minimum of 5 years of experience working in a laboratory setting, preferably in the biotech industry.

· Strong understanding of laboratory techniques, instrumentation, and safety protocols.

· Knowledge of regulatory requirements and compliance standards, particularly in the biotech or life sciences industry.

· Strong organizational and multitasking abilities, with attention to detail and accuracy.

· Excellent communication and interpersonal skills, with the ability to collaborate effectively with colleagues at all levels.

· Proven leadership skills with the ability to effectively manage and motivate a team.

Extremely reliable, organized, planning and hard-working. Willing to go the extra mile to ensure the lab operates smoothly.

Education

Bachelor's or master’s degree in chemistry, pharmacy, biology, biochemistry, or a related field.

Preferred industry background 

Biopharmaceutical industry

Mission:

As a RadioPharma Supply Operations Specialist, you manage an efficient and reliable supply chain for Radioisotope and critical components supply to the CDMO’s for drug manufacture. You also plan the dispatch of the produced drug to patients administration sites.

Key Responsibilities:

• Lead sourcing operations and execute procurement contracts and agreements for Radioisotopes for the Belgian Office.

• Expedite external and internal documentation related to the Purchase Orders assigned in order to have timely documentation submission and approvals.

• Make order management including follow up of the entire chain of logistics with import and export.

• Ensure the timely receipt of required permissions and other documents for customs operations by keeping close communication with third party partners (transportation and customs clearance companies)

• Manage day-to-day operation with suppliers

Profile:

• Bachelor’s degree or equivalent in Supply Chain or Logistics or Business Administration related fields.

• Minimum 3 years Industry experience in supply chain. An experience in Pharmaceutical or Radiopharmaceutical environment is a plus.

• Working knowledge of import and export requirements in a regulated environment.

• Fluency both in English and French.

• Strong analytical, planning and organizational skills.

• Experience in Multicultural, Global environment is an advantage.

• Solution-oriented and collaborative mindset.

• Flexibility to adapt to change.

Offer:

• A stimulating and challenging position within a fast-growing global startup company, in which you get to bring your knowledge and skills.

• The opportunity to work in a dynamic, professional, and multicultural environment.

• A permanent contract with an attractive salary package in line with the position responsibilities and your experience.