Director, PK-ADA, Biologics
At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.
Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry. The Director, PK-ADA, Biologics will be a strong leader who has experience in managing, training, and developing advanced scientific personnel. You will oversee all the projects within the Biologics Department on daily basis to ensure the quality, timeline and deliverable are met. You will also be the main point of contact with clients for all biologics projects, ensuring timely communication and updates. This may include preparing and presenting proposals to the key pharmaceutical and biotechnology clients.
Role & Responsibilities
- Provide strong technical support to the team on different assay formats. Ability to trouble-shoot and solve technical issues.
- Review bioanalytical documentation that includes study protocols, method validation plan, sample analysis plans, data packages, validation study reports and sample analysis reports.
- Write and update SOPs. Maintain GLP compliant PK and immunogenicity Labs.
- Support Business Development including reviewing proposals and meeting with new clients.
- Ensure delivery of high-quality bioanalytical data and regulatory documents (IND, BLA, global filings) as well as health authority interactions and scientific contributions
- Maintain up to date knowledge of applicable scientific trends & technologies as well as industry regulations.
- Ensure new bioanalytical technologies are being assessed and incorporated when appropriate.
- Manage several concurrent responsibilities and projects
- Provide mentoring and career development of staff, and other employees as requested
- Hire, conduct performance reviews, train staff on laboratory procedures Ensure regulatory compliance and scientific oversight of bioanalytical programs
- Ensure a safe work environment is maintained at all times
- PhD in Biology, Immunology, Chemistry, or related field and a minimum of 10 years of directly-related experience
- Hands-on experience in ligand binding assays, especially PK and ADA method development.
- Experience in managing, training and developing advanced scientific personnel
- Strong experience and knowledge of method development / validation for supporting regulated studies
- Excellent communication and interpersonal skills and project management skills.
- Solid knowledge of GLP practices for bioanalytical laboratories and familiarity with ICH, FDA and EMA guidance, as well as USP and industry suggested best practices, regarding bioassay advancement and management
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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