Lead Process Development activities focused on small-molecules. Work with internal and external team members to meet Company time lines and objectives. Responsible for overseeing manufacturing, supply chain, procurement and distribution activities for drug substance as well as assist with preparation of process development sections for regulatory submissions. Also responsible for participating in and supporting novel drug development projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Lead the process development, manufacture, release and stability of portfolio drug candidates
- Assist in RFP writing, technical transfer, route optimization, qualification and validation of activities related to all manufacturing operations
- Manage drug substance specifications and supply chain to support GLP toxicology programs through clinical trials by efficient planning and maintenance of inventory and distribution of drug substance in all territories
- Alongside Quality Assurance and Regulatory Affairs, evaluate third-party manufacturers and assist in negotiating effective supply/technical agreements
- Design and oversee execution of process development activities in preparation for Registration and Validation activities.
- Assist in the management and execution of Primary/Registration activities in preparation for regulatory filings
- Assist with the writing of drug substance sections of regulatory documents, including Investigator's Brochure, Pharmacy Manual, Study Protocols, IND filings, IMPD, and DMFs
- Track proposals and invoices to insure alignment with approved CMC budget.
- Manage consultants, vendors, and CROs/CMOs to meet aggressive program timelines/budgets
- Perform other duties as required
- PhD in organic chemistry and 8+ years of hands on multi-step drug substance synthesis experience on process scale with increasing responsibility in biopharmaceutical development.
- Must have experience in writing/assisting with CMC documents for regulatory submissions and a good understanding of pharmaceutical development, quality and regulatory issues.
- Must have hands on working experience with early stage of drug development, as well as in-depth knowledge and understanding of GMP requirements and CMC regulatory requirements for small molecule drug candidates.
- Has demonstrated flexibility within a high paced, changing environment
- Excellent communication skills and the ability to work in a goal and team-oriented setting.
- Well-developed organizational skills with the ability to handle multiple projects and thrive under pressure
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.