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

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

REQUIREMENTSEducation:A Doctorate (PhD) or Master 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.
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.

OTHERSupervisory Responsibilities:None.Equipment To Be Used:Laptop computer, other office equipment, and/or lab equipment.Typical Physical Demands:Manual dexterity sufficient to operate standard office equipment.Working Conditions:Works in a typical office setting. Occasionally called upon to work hours in excess of your normal daily schedule.
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

RemeGen Biosciences is an Equal Opportunity Employer. RemeGen Biosciences’ success depends heavily on the effective utilization of qualified people, regardless of their race, ancestry, religion, color, sex, age, national origin, sexual orientation, gender identity and/or expression, disability, veteran’s status, or any other characteristic protected by the law. As a company, we adhere to and promote equal employment opportunity (EEO) for all.

Must be able to work legally in the United States without sponsorship from the employer.

RemeGen Biosciences

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Director/Sr Director, Biologics Process Development