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

The Role:

• Pivotal role in supporting the organization's talent needs, employee well-being, and HR initiatives that contribute to the success of groundbreaking research and developments in biotechnology.

• This role is essential in managing various human resources areas that support the organization's workforce and strategic objectives.

Key Responsibilities:

1. Recruitment and Talent Acquisition: 

Collaborate with hiring managers to identify staffing needs and develop effective recruitment strategies. The job holder will be involved in job postings, candidate sourcing, conducting interviews, and ensuring a smooth onboarding process for new hires with a focus on attracting and retaining top talent in the biotechnology field.

• Collaborative Hiring:

Collaborate closely with hiring managers and cross-functional teams to understand their talent needs, provide market insights, and guide them through the recruitment process.

• Talent Market Research:

Stay informed about industry trends, salary benchmarks, and the competitive landscape within the biotechnology sector. Use this knowledge to advise on recruitment strategies and maintain a competitive edge in talent acquisition.

• Candidate Experience:

Provide a positive and professional experience for candidates throughout the recruitment process. Ensure timely and personalized communication, feedback, and updates on the status of their applications.

2. Internal HR Communications:

Develop and execute communication plans to inform employees about HR policies, benefits, performance management, training programs, and other HR-related updates. Create engaging content such as newsletters, emails, intranet articles, and announcements to ensure employees are well-informed and connected with HR initiatives.

3. Employee Relations: 

Foster positive employee relationships by addressing employee concerns, mediating conflicts, and promoting a harmonious work environment. Ensure employees' rights are protected and that the company adheres to relevant labor laws and regulations.

4. Performance Management: 

Support the performance management process by assisting in setting performance goals, conducting performance evaluations, and providing feedback to employees and managers. Role may involve coaching managers on effective performance management techniques.

5. Training and Development: 

Coordinate and facilitate training programs to enhance employees' skills and knowledge in biotechnology-specific areas. Work to foster a culture of continuous learning and development to keep the workforce updated on industry trends and advancements.

6. Benefits and Compensation: 

Administer and manage employee benefits programs, including health insurance, retirement plans, and other perks. Participate in compensation benchmarking and assist in salary reviews and incentive programs.

7. HR Policies and Compliance: 

Develop and implement HR policies and procedures that align with industry regulations and the company's values. Ensure compliance with labor laws, employment standards, and industry-specific regulations relevant to the biotechnology sector.

8. Employee Engagement: 

Initiate and participate in employee engagement initiatives to boost morale and create a positive work environment. Encourage teamwork, innovation, and a sense of purpose among employees.

9. Organizational Development: 

Collaborate with HR leadership and management on organizational development initiatives. This may include succession planning, workforce planning, and change management to support the company's growth and adaptation to industry demands.

10. HR Metrics and Reporting: 

Use HR data and analytics to generate reports and insights for HR leadership and company management. Help make informed decisions related to talent management and overall HR strategies.

11. Health and Safety: 

Ensure compliance with health and safety regulations specific to the biotechnology industry. Maintain a safe and healthy work environment for all employees.

Qualifications:

• Bachelor’s degree in human resources, Business Administration, or a related field is required.

• Minimum 5 years of experience in HR Operations, preferably within the pharmaceutical or life sciences industry.

• Comprehensive understanding of nuclear medicine, oncology, and associated production processes.

• In-depth knowledge of HR processes, employment laws, compliance, best practices and industry trends.

• Excellent organizational and project management skills.

• Attention to detail and ability to work with sensitive and confidential information.

• Excellent communication and interpersonal skills.

• Excellent level of English and French, Mandarin would be a plus.

• Prior experience working in an international environment is a plus.

Key Responsibilities:

• Support program management in defining project scope, goals, and deliverables to advance programs through stages of early clinical development to commercialization.

• Compilation and monitoring of project timelines and milestones, assigning tasks, and ensuring timely completion by team members.

• Assemble, organize, and manage operations of a cross-functional Program Team including but not limited to Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, Preclinical, CMC, Marketing/ Commercial.

• Facilitate communication and information flow, comprising project updates, progress reports, and addressing any concerns or queries, across interdisciplinary teams and all relevant cross-functional stakeholders.

• Identify potential risks and assist in developing mitigation strategies to ensure successful project execution.

• Maintain project documentation, including project plans, schedules, budgets and reports.

• Assist in monitoring project quality standards and ensuring adherence to project specifications.

• Preparation of internal program team meetings, including agendas, participant and speaker preparation, meeting materials, meeting management, meeting minutes and follow-up.

• Assist with applying change, risk, and resource management.

Qualifications:

• MSc/Diploma in life science or a comparable field.

• 1-3 years' experience in the relevant area. Therapeutic knowledge in the areas of immunology or immuno-oncology. Knowledge in radiotherapeutics is beneficial.

• Experience to work cross-functionally/ in a matrix structure and fast paced environment.

• Understanding of project/program management techniques and methods.

• Certificate and/or experience in project management is a strong advantage.

• Excellent knowledge of MS Office (Word, Power Point, Excel, One Note and MS Teams); working knowledge of program/project management software, etc. is a plus.

• Fluent in English (oral and written).

• Eagerness to learn and grow withing the field of project management.

• Outstanding organizational skills, excellent problem-solving ability and hands-on work mentality.

• Excellent communication and interpersonal skills.