Responsibilities:

1. Design and perform analytical analysis for chemical and biologics projects such as small molecule drug, antibody, fusion protein, and ADC, to support analytical method development and validation during chemical and biological drug development.

2. Literature search to solve problem as needed.

3. Analytical screening to support early-stage biologics project development, such as cell line and process development.

4. Analytical method development for early-stage chemical product (DS and DP) and stability study.

5. Analytical support for tech transfer of chemical and bio-product. Draft or review or approve related SOPs, study protocol and report to support chemical and biological product localization and comparability study.

6. Support RS, DS, DP retention sample and stability study management and compliance to regulatory requirement.  

7. Prepare CMC documents for IND, IMPD and NDA.

Qualifications:

1. Master or PhD’s degree of analytical chemistry or biochemistry related background with 3-8 years of industrial experience.

2. Highly self-motivated individual with hands-on experiences in analytical development for small molecule products or biologics large molecule like mAb, BsAb, fusion protein and ADC, including but not limited to HPLC, UPLC, LC-MS, CGE, CZE, ELISA. Support analytical development of chemical or biological products for drug-discovery and early CMC development.

3. Well trained with QC’s basic operation sense. Familiar with analytical/characterization requirement for CTD document preparation. 

4. Experience with writing and reviewing development reports, SOPs, and record in English.

5. English oral communication will be a plus.

Responsibilities:

1. Provide technical leadership, management, oversight and strategic guidance for early and late-stage programs including process development, scale up, tech transfer, scale-down model, process characterization, process validation and BLA-enabling activities.

2.  Author and review CMC sessions for regulatory submissions.

3. Oversee and define project scope and ensure successful delivery regarding technical quality, timeline, and budget.

4. Work with cross-functional teams and support senior leadership in defining and executing against short-term and long-term strategic goals.

5.  Work with internal team and external partners to create, optimize, and develop new process for cost and production efficiency improvement.  

6. Apply innovative thinking and technical knowledge to design experiment and analyze data.

7.  Ensure well-organized, clear and complete records of all activities across areas of responsibility.

Qualifications:

1. Requires a PhD with 6-10 years of process development leadership experience in biotech industry.

2. Significant experience in the areas of process development, scale up and GMP manufacturing, process optimization, tech transfer, process validation and BLA-enabling activities.

3.  Experience in preparing and defending regulatory documents (BLAs/INDS)

4. Knowledge of cGMP regulations. Strong experience and knowledge in process validation highly desired.

Responsibilities:

1. Work with internal team and external partners to create, optimize, and develop chemical synthetic path and process.

2. Prepare regulatory documents; prepare and review R&D reports, tech-transfer package, patent application and other technical documents.

3. Work with external partners (CMOs) to implement production of APIs or intermediates and ensure on time delivery of high-quality products to support drug development programs.

4. Work with external partners to implement tech-transfer.

5. Serve as the expert in the area of process chemistry, contribute to internal cross function project team and buildup of CMC function.

6. Other assigned duties to meet company objectives.

Qualifications:

1. PhD in synthetic chemistry with 5+ year experience in the field of chemistry or related; oversea education or work experience in multinational companies will be a plus.

2. Solid experience in preparation of regulatory filing documents.

3. Demonstrated scientific credibility in the field of process chemistry, strong skills of problem solving.

4. Experience in working with/at CRO or CMO; and experience on plant production.

5. Good technical writing skills in both Chinese and English; Strong communication and influencing skills.

6. Extensive knowledge of general drug R&D process and knowledge of GMP production. 

Responsibilities:

1. Provide strategic and technical regulatory inputs to contribute to decision making on drug development and life cycle management strategy

2. Responsible for regulatory activities of the assigned products, including pre-IND, IND/MRCT, pre-NDA/BLA, and NDA/BLA submissions, ongoing interactions/follow-up/supplemental submissions, with competitive timeline and high quality

3. Manage vendors as needed to support regulatory submission goals.

4. Interface with regulatory authorities as a primary contact person to Liaise and negotiate effectively to ensure timely regulatory approvals

5. Prepare and participate in audits/inspections (internal/external audits, supplier and document audits) when needed

6. Closely follow up the changes to the regulatory environment

7. Responsible to ensure full compliance to the regulatory requirements of NMPA, CDE, NIFDC, etc. as well as relevant overseas health authorities

8. Support internal R&D projects & clinical DD projects with timely and precise regulatory assessment.

9. Other related tasks assigned by supervisor

Qualifications:

1. Bachelor’s degree (advanced degree preferred) in a life science field (e.g., Medicine, Biology, Pharmaceutical sciences)

2. +5 years Regulatory Affairs experience of drug development and registration activities (esp. IND & NDA approval) in pharmaceutical or biotech industry.

3. Good communication skills, proven ability to work effectively with cross-functional teams

4. Familiar with Biologics Regulatory techniques throughout the whole product life cycle, CMC development, and/or pre-clinical to commercial etc preferred