1+ months

Director of Drug Substance Development

Kelly Services
Blacksburg, VA 24063
Kelly Services is actively recruiting for a **Director of Drug Substance Development,** who will be responsible for API and synthetic chemistries activities including route development, process chemistry and chemical manufacturing from early phase development through commercial launch.

**This is a Direct Hire, remote opportunity!**

This position will collaborate with members of the CMC team and Regulatory Affairs to develop and implement API manufacturing and regulatory strategies of development candidates. The Director of Drug Substance Development will be well-versed in analytical and synthetic chemistry, as well as FDA and EMA regulations, in order to navigate the development of small molecule therapeutics for autoimmune diseases.

Key Responsibilities includes:

**CMC Management** : Interact with contract manufacturing organizations to plan and

execute the production of drug substances for all phases of development. Provide a

critical detailed review of specifications, analytical procedures, process chemistry,

manufacturing batch records, product labeling, and other CMC data.

** Discovery Chemistry** : Provide critical insight for synthesis routes of novel chemical

entities to advance discovery-based R&D. Propose, troubleshoot and revise

synthetic routes outsourced to contract manufacturing organizations. Provide full

evaluation of potential process impurities and formal assessment of their potential

mutagenicity/carcinogenicity (ICH M7).

** Data analysis and reporting** : Utilize established and novel methods to analyze data. Data types will include but are not limited to NMR, HPLC, MS, in silico docking and surface plasmon resonance, among others. Provide detailed reports of current status of primary assets and new chemical entities. Generate figures, presentations and publications to communicate results with scientific community, investors, and collaborators. Support the development of patents and grants relevant to on-going research.

**Quality:** Assist the Head of CMC and Head of Quality to ensure that contract

manufacturers operate under cGMP in the manufacture and release of APIs used for

CTM manufacture for use in clinical trials.

**Regulatory Affairs** : Identify, assess and communicate potential project challenges and conduct risk mitigation strategies pertaining to drug substance activities. Coordinate and outline the necessary drug substance activities in line with the overall development plan of individual assets. As directed by Head of CMC, author, review and finalize drug substance documents for IND and NDA submissions, as well as annual reports. Maintain a current knowledge of CMC regulations and guidance.

Member of global cross-functional teams which require experienced interpretation of

applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization.

Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Provides solutions to prevent recurrence of issues.

**Education/Experience Requirements:**

+ Ph.D. in organic chemistry, medicinal chemistry or related chemistry discipline.

+ Minimum 10-15 years of drug substance experience in the pharmaceutical industry.

+ Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development.

+ Proven ability to liaise with Regulatory Agencies, having experience in CMC submissions and product development meetings; interactions with regulatory agencies.

+ International experience preferred.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2022-07-13 Expires: 2022-09-12

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Director of Drug Substance Development

Kelly Services
Blacksburg, VA 24063

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