Director/Sr Director, Biologics Process Development
Director/Sr Director, Biologics Process Development
RemeGen Biosciences
Pennsylvania, United States
See who RemeGen Biosciences has hired for this role
The Director/Sr Director, Biologics Process Development willprovidestrong scientific direction, technical and managerial leadership in support of RemeGen’s clinical development programs and their commercialization. The Director/Sr Director, Biologics Process development will build and manage a team of scientists and research associates to lead all process development activities. This individual will be responsible for interacting with analytical development, quality control, manufacturing, quality assurance and regulatory departments to enable the timely development and transfer processes of biologics drug substances to provide clinical materials for the company’s global clinical programs. The Position reports to the company's Vice President of Process Development.
KEY RESPONSIBILITIES
Experience:
10+ years in one of the CMC functions with a proven track records of moving biologics products through the approval process. Demonstrated knowledge, experience, and successful track records in leading upstream or downstream process development functions. Candidates must have exposure to late phase development, be conversant with good manufacturing practices and have a working knowledge of ICH guidelines.
Skills:
COMPENSATION & BENEFITSBenefits:
Must be able to work legally in the United States without sponsorship from the employer.
KEY RESPONSIBILITIES
- Designscientific approaches and usebest industry practices in support of process development and transfers for the company’s biologics drug candidates.
- Writeand reviewrelated CMC sections for the company’s IND and BLA filings.
- Workclosely with Analytical Development, Manufacturing, Quality Control, Regulatory, and Quality Assurance to ensure successful tech transfers and validations.
- Maintaina current awareness about biologics development and associated drug/device combinations.
- Ensurethe timely preparation, review, and approval of technical reports, monographs, appropriate sections of regulatory submissions, etc.
- Apply technical and management expertise to meet project goals and timelines, and to make technical and management decisions to keep projects on track.
- Buildand maintainstrong working relationships with relevant internal and external stakeholders as well as partner companies, ensuring that activities are managed collaboratively, efficiently and effectively
Experience:
10+ years in one of the CMC functions with a proven track records of moving biologics products through the approval process. Demonstrated knowledge, experience, and successful track records in leading upstream or downstream process development functions. Candidates must have exposure to late phase development, be conversant with good manufacturing practices and have a working knowledge of ICH guidelines.
Skills:
- Possesesa broad technical experience/expertise across the following disciplines: large molecule process characterization and validation for antibody, fusion protein and/or antibody-drug conjugates (ADC) products.
- 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.
- Bilingual in Chinese is a plus.
COMPENSATION & BENEFITSBenefits:
- 401(k) and matching program
- Medical, Vision, and Dental Insurance
- Flexible Spending Account
- Short- and long-term disability
- Life insurance
- Employee Assistance Program
- Employee discounts
- Paid time off/vacation/sick time
- Professional development assistance
- Referral program
Must be able to work legally in the United States without sponsorship from the employer.
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Seniority level
Director -
Employment type
Full-time -
Job function
Other -
Industries
Biotechnology
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