SVP, CDMO Services

Job Title: Senior Vice President, CDMO Services

Reports to: CEO

Location: Exton, PA (On-site)

Compensation: Competitive (includes base, bonus, equity & generous benefits)

About Us:
 

Frontage Laboratories Inc. is an award-winning, publicly listed, science driven, full-service global CRO, founded 24 years back and is HQ in Exton, PA. We operate over 25 state-of-the-art facilities across the US, Canada, China and Europe providing comprehensive portfolio of services including Drug Discovery, Drug Development, Bioanalytical Services, Pharmaceutical Product Development, CMC, clinical and Laboratory services. With a strategic vision to strengthen our CDMO services CMC (Chemistry, Manufacturing, and Controls) and PDM (Product Development & Manufacture), Frontage has recently built a cutting-edge, ~40,000-square-foot laboratory in Exton, PA. This state-of-the-art facility is now fully prepared to commence operations to support CTM and small commercial products.

Position Overview
 

We are seeking a well-experienced and visionary leader to join our team as Senior Vice President or VP (depending on experience) and lead our CDMO services, including CMC (Chemistry, Manufacturing, and Controls) and PDM (Product Development & Manufacture). This leader will play a critical leadership role in developing and driving the strategy, operations, business development, optimization, commercialization and growth of these services, with full P&L responsibilities. The SVP/VP will develop, lead and oversee all aspects of this business, ensuring the successful advancement of our pipeline from preclinical through clinical development and commercialization.

Key Responsibilities

• Business Leadership: Develop and execute the overall CDMO programs, including CMC and PDM, achieving corporate revenue and profit goals.
• CMC/PDM Strategy: Lead the development and implementation of strategies, including process development, scale-up, and technology transfer to manufacturing partners.
• Budget and Resource Management: Develop and manage budgets, resources, and timelines to ensure successful project execution.
• Client Management: Develop and maintain strong relationships with external partners, including clients, vendors and stakeholders, to ensure timely and high-quality deliverables.
• Regulatory Compliance: Ensure compliance with global regulatory standards (FDA, EMA, etc.) on GMP and support the preparation of regulatory submissions (IND, NDA, BLA, MAA).
• Cross-Functional Collaboration: Work closely with Quality Assurance, Technology, Business Development, Finance, Legal, Manufacturing, and Clinical Development teams to ensure seamless integration of analytical and CMC activities across the product lifecycle.
• Team Leadership: Mentor and lead a high-performing team of scientists and professionals in analytical development, Cell and Gene Therapy, and CMC functions.
• Innovation and Continuous Improvement: Stay abreast of emerging technologies and industry trends, driving innovation and continuous improvement.

Qualifications

• An advanced degree such as Ph.D., or equivalent in Biochemistry, Chemistry, Bioengineering or a related field.
• Minimum of 15 years of experience in the biotechnology, pharmaceutical or CRO industry, with at least 10 years in a leadership role within the CDMO sector including CMC and PDM
• Strong knowledge of global regulatory requirements and guidelines.
• Proven track record of successfully advancing services through product development and commercialization.
• Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate across all levels of the organization.
• Strategic thinker with strong problem-solving skills and the ability to manage multiple priorities in a fast-paced environment.

Salary and Benefits

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.