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Associate Director / Director - CMC

Company: Certara Inc.
Location: New Haven
Posted on: June 12, 2021

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:

  • 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.

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.

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Keywords: Certara Inc., New Haven , Associate Director / Director - CMC, Other , New Haven, Connecticut

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