Associate Director / Director - CMC
Company: Certara Inc.
Location: New Haven
Posted on: June 12, 2021
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Job Description:
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
submissions. 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. Job Summary 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! Responsibilities 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: 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. About Certara 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
lives: 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
program Growth & Development - performance driven environment Community Impact - volunteering opportunities, matching gifts,
charitable contributions 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. #LI-LD1
Keywords: Certara Inc., New Haven , Associate Director / Director - CMC, Other , New Haven, Connecticut
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