CMC lead, SME

About GenScript

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

About ProBio:

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.

About the job

The incumbent will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical teams and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting Probio’s services at conferences/trade shows. This position will offer the candidate flexibility working remotely from home in US or EU locations.

Key Responsibilities:

- Provide project and technical support to BD during pre-sales activities, including delivering service presentations and engaging in technical discussions to enhance the "opportunity-to-order" conversion rate in the US/EU regions.

- Collaborate with CMC functional areas to ensure successful execution of various biologics CMC projects, and delivery of results on time and within budget.

- Engage efficiently with key stakeholders to ensure transparency on program status and alignment on program plans, goals, resource requirements, and timelines.

- Participate in face-to-face client visits with the BD team to promote company services and capabilities, ensure alignment between probio and clients.

- Collaborate with PM to provide technical insights and review proposals.

- Serve as the Project Leader for integrated projects from US/EU clients.

- Support BD efforts and proposal writing team to enhance current service offerings and develop new clients.

Qualifications:

- PHD. in Biopharmaceuticals or a related field with at least 3 years industry experience; or a master’s degree with at least 7 years of experience.

- The working experience should be in CMC related area and in biopharma/biotech, including cell line development, process development, GMP production, RA and so on.

- Good track record on IND and BLA project for antibody & protein biologics.

- Excellent expression capabilities and communications skills. Good cooperation with multiple internal functions including BD, PM, MKT and production teams.

- Strong leadership, problem solving, and project management skills.

- Strong motivation to achieve challenging goals and good understanding of the business workflow.

- Proficiency in both oral and written English.

#PB

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Benefits:

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.