Vice President, Analytical Development and Quality Control
Yantai, Shandong, China
Full Time
Executive
POSITION DESCRIPTION:
The Vice President, Analytical Development and Quality Control, will provide strong scientific direction, technical and managerial leadership in support of Remegen’s clinical development programs and their commercialization. This individual will be responsible for interacting with analytical development, process development, quality control, manufacturing, quality assurance, and regulatory departments to enable the timely development, transfer, and implementation of analytical methods as well as management of all biologics release testing and stability programs. As a senior member of the company’s development team, this person will work closely with all functions throughout the organization, as well as key external parties and stakeholders at partner companies.
This is a full-time position based in Yantai, Shandong, China, and reports to the Chief Operating Officer (COO). Have excellent leadership, management, and communication skills; MUST be able to speak & read bilingual (English and Chinese) languages. Send your resume to [email protected].
Responsibilities include:
POSITION REQUIREMENTS:
The Vice President, Analytical Development and Quality Control, will provide strong scientific direction, technical and managerial leadership in support of Remegen’s clinical development programs and their commercialization. This individual will be responsible for interacting with analytical development, process development, quality control, manufacturing, quality assurance, and regulatory departments to enable the timely development, transfer, and implementation of analytical methods as well as management of all biologics release testing and stability programs. As a senior member of the company’s development team, this person will work closely with all functions throughout the organization, as well as key external parties and stakeholders at partner companies.
This is a full-time position based in Yantai, Shandong, China, and reports to the Chief Operating Officer (COO). Have excellent leadership, management, and communication skills; MUST be able to speak & read bilingual (English and Chinese) languages. Send your resume to [email protected].
Responsibilities include:
- Contributes as a key member of the company’s CMC development committee to ensure analytical development strategies meet the company’s program needs.
- Leads the ADQC department and manages internal teams and external partners (CROs/CDMOs) to ensure project timelines are met.
- Designs scientific approaches and uses best industry practices in support of method transfers and method validations while maintaining compliance with GMP guidelines at all times.
- Writes and reviews related CMC sections for the company’s IND and BLA filings.
- Leads the establishment of specifications for in-process controls, drug substances, and drug products.
- Works closely with Analytical Development, Manufacturing, Quality Control, Regulatory, and Quality Assurance to ensure successful tech transfers and validations.
- Maintains a current awareness about biologics development and associated drug/device combinations.
- Ensures the timely preparation, review, and approval of technical reports, monographs, appropriate sections of regulatory submissions, etc.
- Applies technical and management expertise to meet project goals and timelines, and to make technical and management decisions to keep projects on track.
POSITION REQUIREMENTS:
- A Doctorate (PhD) or Master's degree from an accredited college or university in one of the following areas: Biochemistry, Analytical Chemistry, Protein Chemistry, or a related scientific discipline with relevant industrial experience in analytical development and/or quality control with a major pharmaceutical, biotechnological, or a generic pharmaceutical company.
- 15+ years in one of the CMC functions with a proven track record of moving biologics products through the approval process. Demonstrated knowledge, experience, and successful track records in leading analytical development or quality control functions. Candidates must have exposure to late-phase development, be conversant with good manufacturing practices, and have a working knowledge of ICH guidelines.
- Possesses a broad technical experience/expertise across the following disciplines: large molecule characterization, mAb formulation/product development, large molecule analytical method development/testing, specification setting for antibody, fusion protein, and/or antibody-drug conjugates (ADC) products.
- Builds and maintains strong working relationships with relevant internal and external stakeholders as well as partner companies, ensuring that activities are managed collaboratively, efficiently, and effectively.
- Sound understanding of CMC regulatory requirements for biologics and direct experience with compiling CMC sections for IND and BLA. Previous active participation in writing and reviewing of CMC sections of regulatory submissions.
- Excellent written and verbal communication skills. Team-oriented, progressive thinker with a can-do attitude who enjoys participating in an innovative and creative work environment.
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