$100K — $150K *
Certara is seeking an experienced Chemistry, Manufacturing, and Controls (CMC) leader (Assoc Director level) to provide substantial CMC strategic support and stewardship with integrated drug development collaborations with a wide range of clients including global health, not for profits, as well as biotechs/big pharma. The candidate will work with the management to grow the CMC capability within Certara Strategic Consulting. Our team includes thought leaders who are among the most well respected in the growing industry of small and large molecule platforms! If working alongside smart and driven colleagues sounds exciting to you, we want you on our team!
Expand Certara CMC business
Provide strategic CMC support for Certara’s clients covering
Develop, manage, and coordinate a network of subject matter experts to meet technical specific needs
Product development strategies for client companies
Provide CMC Regulatory support and advice
Lead supply chain planning
Strategic assessment of acquisition opportunities through diligence activities, data review, and program planning oversight In conjunction with the SME network provide clients with:
Supporting the development of CMC strategies and execution plans, providing operational oversight when needed
Strategic CMC advice and support to clients
Ensuring compliance with national and international regulations including cGMP and ICH guidelines
Guidance on the impact of climate zone and storage/transportation conditions on stability and Regulatory requirements
Guidance and potentially overseeing the use of CDMOs for CMC activities
Technical leadership for client CMC programs in the areas of:
- Sterile product manufacturing (small molecules and biologics)
- Oral dosage forms, preferably including complex oral dosage forms such as fixed dose combinations
- Drug-Device combinations such as prefilled injection and inhalation devices
- Additional areas may include: topical products, medical devices, API manufacturing, analytical development, technology transfer, & quality systems
- Responsible for ensuring cross-cutting activities are facilitated in a manner that guarantees clear communication
Skills & Abilities
A minimum of 6-8 years of CMC development experience in industry.
PhD degree preferred.
An in-depth expertise of at least two CMC areas (API, Process Development, analytical, formulation, devices, GMP Quality, manufacturing, supply chain) with working knowledge of the others (extensive network of SMEs).
Experience leading CMC efforts as part of an integrated drug development team.
Team Leadership and Project Management experience, combined with working across multinational organizations.
CMC Regulatory experience is a plus.
Strong communication skills.
Entrepreneurial and self-starter skills.
Access to an extensive network of SMEs preferable.
Some travel may be required.
Excellent written, verbal and inter-personal communications skills.
Must be able to work well with a team in a multidisciplinary environment.
Requires a self-motivated individual who can work independently and remotely.
Should possess the requisite experience to work in a light-touch management environment and focus on client needs.
Valid through: 4/24/2021
$100K — $150K
4 days ago