Certara is hiring an Associate Director/Director in Early Drug
Development Services to support our Integrated Drug Development
team! This position can be located anywhere in the US.
About Certara Strategic Consulting
Certara Strategic Consulting is the largest MIDD organization in
the world and assures that various career pathways are offered to
match the ambition and personal interests of our employees!
Integrated Drug Development is a division of Certara which aims to
deliver value by leveraging the application of MIDD approaches into
drug development deliverables-to speed up drug development, inform
internal decision-making and strengthen global regulatory
This role will be part of the Early Drug Development support
services group within Certara delivering high quality drug
development consulting to client companies. Leveraging our
experience working on thousands of key drug development projects on
behalf of hundreds of biopharma companies, we bring a track record
of success and a broad range of expertise to each assignment.
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
Guidance and potentially overseeing the use of CDMOs for CMC
Technical leadership for client CMC programs in the areas
- Sterile product manufacturing (small molecules and
- Oral dosage forms, preferably including complex oral dosage
forms such as fixed dose combinations
- Drug-Device combinations such as prefilled injection and
- 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
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
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
Must be able to work well with a team in a multidisciplinary
Requires a self-motivated individual who can work independently
Should possess the requisite experience to work in a light-touch
management environment and focus on client needs.
Certara is a growing company that provides a novel and exciting
place to work. Our purpose is to assist in accelerating the
development of meaningful medicines that make an impact on our
society and the people that need them most. Innovation and
creativity are highly valued, and everyone is given the opportunity
for training and continuous development. Our portfolio spans the
discovery, preclinical, clinical and post-marketing phases of drug
development, working with 1,200 commercial companies, 250 academic
institutions, and numerous regulatory agencies.
The well-being of our employees is a priority at Certara, and
that is why we support the most important aspects of their
Financial - competitive pay, incentives, retirement plans,
income security programs
Health and Wellness - comprehensive benefit package, wellness
programs, healthy lifestyle office environments
Work/Life -unlimited paid time off and an employee assistance
Growth & Development - performance driven environment
Community Impact - volunteering opportunities, matching gifts,
Certara is an Equal Opportunity Employer. Certara does not
discriminate on the basis of race, religion, color, sex, gender
identity, sexual orientation, age, non-disqualifying physical or
mental disability, national origin, veteran status or any other
basis covered by appropriate law. All employment is decided on the
basis of qualifications, merit, and business need.