Website HengRui USA
HengRui USA is the US hub for our parent company Jiangsu Hengrui Medicine (600276 SHA), a global pharmaceutical company with around $90 Billion market value, $3.6 Billion annual revenue (data by 2019) and over 30,000 employees globally. The product line includes antineoplastic drugs, angiomyocardiac drugs, surgical drugs, contrast agents and antibiotics. The pipeline across different therapeutic areas such as oncology, autoimmune, pain management, metabolics etc.
In HengRui USA, we recognize, appreciate, and reward our team’s contributions; we emphasize our people’s well-being. We want you to feel empowered to do your best work, in a place where you are respected, engaged, fulfilled, and developing!
Director Pharmaceutical Sciences
Location: Princeton, NJ
The Director of Pharmaceutical Sciences will be responsible for the establishment and alignment of the CMC development plan, manufacturing, clinical supply and the Analytical Development function for HengRui USA therapeutic clinical development programs. This person will work in close collaboration with the HengRui Medicines HQ and cross-functional CMC teams and will direct, oversee, and deliver scientific and analytical strategies, including but not limited to method development, method validation, phase-appropriate control strategies, characterization, and comparability.
- Provide technical and strategic leadership and support in the establishment of phase-appropriate analytical control strategies and the development of analytical methods for in-process and product release testing, and product characterization across the development lifecycle of HengRui’s products.
- Apply GMP manufacturing strategies of drug substances for development programs and commercial products.
- Support the process chemistry for rapid and innovative development and scale up of target compounds in R&D pipeline.
- Where appropriate, work with HengRui HQ to identify, select and manage CMOs for process optimization, cGMP manufacture and supply of API and DP in support of ongoing non-clinical and clinical programs
- Work to implement stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards
- Author/review/approve key documents such as analytical target profiles (ATP) comparability protocols, control strategies, relevant sections of regulatory documents (IND, BLA), etc.
- Support the preparation and approval of comprehensive supporting documentation for developed analytical methods.
- Maintain strong strategic partnerships across CMC partners to drive programs through clinical development efficiently and effectively.
- Build upon and shape the scientific knowledge, capabilities, and strategies that enable fast-to-clinic/fast-to-market product development for HengRui pipeline
- Operational focus, fiscal accountability and long-term strategy in sync with HengRui pipeline, commercial portfolio and company strategy.
- Identify and communicate risks and implement effective mitigation strategies.
- Act as Subject Matter Expert for knowledge of GMP regulations, ICH guidance, and current regulatory expectations regarding DS and DP development and control.
- Serve as Pharmaceutical Sciences subject matter expert for any business development diligence activities.
- Build and lead a strong Analytical Development team by providing guidance and mentorship. Provide and prioritize learning and development opportunities to build the skills and capabilities of the team.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS
The candidate has a broad understanding pharmaceutical development and CMC-related activities, including extensive in-depth and hands-on experience with analytical development across the product and process development lifecycle. Excellent leadership, communication, and collaboration skills, along with the ability to be nimble and work in a fast-paced environment are crucial.
- Masters or Ph.D. in life sciences-related discipline with 10+ years of pharmaceutical development experience.
- Proven leadership and delivery of new assets from discovery to market.
- Broad hands-on experience in analytical development and technology transfer, across all phases of development through to launch.
- Deep knowledge of phase-appropriate, analytical method, development, qualification, and validation requirements compliant with current global regulatory standards.
- Broad experience in directing the development, validations and implementation of analytical control strategies, characterization, and comparability approaches
- Understanding of product development life cycle and stage gates from research to clinical development to commercial operations
- Broad knowledge of FDA, EMA, and ICH regulations, industry standards, and quality control principles for GMP operations
- Experience with writing validation protocols, validation reports, relevant sections of regulatory documents, IND, IMPD, and BLA
- Excellent communication, collaboration, team-building skills, and interpersonal skills; genuine desire to be on a team and contribute to organizational and team goals
- Bilingual – English & Mandarin preferred